351

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

A pricing lesson for narso & Omer?
===================
Remdesivir Priced At More Than $3,100 For A Course Of Treatment
June 29, 20207:39 PM ET
Heard on All Things Considered
SYDNEY LUPKIN

Gilead Sciences, maker of the antiviral drug remdesivir, has come up with a price for the COVID-19 treatment that was less than some analysts expected.
ULRICH PERREY/POOL/AFP via Getty Images
The drugmaker behind the experimental COVID-19 treatment remdesivir has announced how much it will charge for the drug, after months of speculation as the company tried to figure out how to balance profit and public health needs in the middle of a pandemic.

In the United States, Gilead Sciences will charge $520 per vial for patients with private insurance, with some government programs getting a lower price. With a double-dose the first day, that comes out to $3,120 for the five-day treatment course. For governments in developed countries outside the U.S., it will cost $390 per vial, or $2,340 for the five-day course. How much uninsured patients would pay is still unclear.

Putting A Price On COVID-19 Treatment Remdesivir
"At the level we have priced remdesivir and with government programs in place, along with additional Gilead assistance as needed, we believe all patients will have access," Gilead CEO Daniel O'Day said in an open letter posted Monday morning.

Since then, reaction to the price has been mixed.

Some advocacy organizations and members of Congress say Gilead is taking advantage of Americans during a pandemic.

Rep. Lloyd Doggett, D-Texas, called the price "outrageous."

"Without a taxpayer investment of $99 million, this drug would have been abandoned. It would be on the scrap heap of failures," he tells NPR. "So it's the taxpayer who's really taking the risk here and ought to get the reward of the angel investors that taxpayers are."

Public Citizen, a nonprofit consumer advocacy group, echoed his remarks with a similar sentiment.

"In an offensive display of hubris and disregard for the public, Gilead has priced at several thousand dollars a drug that should be in the public domain," Peter Maybarduk, director of Public Citizen's Access to Medicines Program said in a written statement.

(In a quarterly financial filing, Gilead said its investment in remdesivir for 2020 alone "could be up to $1 billion or more," much of that money used to scale up manufacturing capacity.)

Still, analysts expected Gilead to set a higher price than the company did.

Geoffrey Porges, an analyst at the investment bank SVB Leerink, said the announced price for the drug offers a "spectacularly good value."


Early Results Show Benefit Of Steroid For Very Sick COVID-19 Patients
"It's unprecedented to price the drug below the medical costs that it's saving," Porges said, adding that remdesivir could save up to $40,000 per patient, if it prevents a COVID-19 patient from needing the ICU. And there's even more value that's not built into Gilead's price, he says.

"That ignores the enormous societal value that everybody else gets from making a patient less infectious, for getting a patient back into the community, for getting them back to work sooner," Porges said. "All of those societal benefits aren't even considered in this price."

The Institute for Clinical and Economic Review, or ICER, an influential nonprofit that analyzes drug pricing, said Gilead showed "restraint" and set a "responsible" price.

That said, ICER President Steven Pearson noted that this reasoning assumes remdesivir will eventually be shown to improve COVID-19 survival — something research hasn't yet proven.

A federally funded study by the National Institute of Allergy and Infectious Diseases published at the end of April indicated that remdesivir can shorten COVID-19 patients' hospital stays by about four days. But it's unclear whether the drug also improves survival.

"If further data do not show a clear mortality benefit for remdesivir, then the price of the drug should be dramatically reduced," Pearson said in his written statement.

The drug price will send a message to companies working on other treatments, vaccines and cures for COVID-19. They have been watching remdesivir closely to find out what kind of reward they might expect for their investments, should their own treatments pan out.

At the announced price, Gilead is still expected to profit from remdesivir sales. That should be encouraging for companies currently investing and developing additional COVID-19 treatments and vaccines.

"Gilead will make a good amount of money selling this product," Craig Garthwaite, who directs the health care program at Northwestern University's Kellogg School of Management, told NPR. "And that's really the return other people have been looking at. In the end, really, the other firms aren't necessarily looking at the price Gilead charges. What they're really looking at is, what is the payoff that they get on their investment? "

Until now, Gilead had been donating doses of remdesivir for use in clinical trials and under the Food and Drug Administration's emergency use authorization announced in May. The last of the donated supply was distributed by the U.S. Department of Health and Human Services on Monday.

HHS announced that it has "secured" an additional 500,000 treatment courses for the United States — the majority of remdesivir that Gilead plans to manufacture in July, August and September. Although hospitals and insurers will now be charged for the drug, the federal government will continue to manage distribution, which had initially been plagued by confusion when it began in early May.

Overall, the price is less than the highest estimates of what it might be, but more than the lowest ones, Michael Carrier, a professor at Rutgers Law School who specializes in antitrust and pharmaceuticals, told NPR.

"Shareholders aren't getting the maximum they wanted but that's to be expected in this environment," he wrote in an email. "With no simple way to determine what a drug is worth, there will always be plenty to debate!"

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: Narsoplimab, MASP2, Lectin Pathway & COVID

Why can't Omeros get a deal like this.  The deal is based on them getting FDA approval.  So why doesn't Greg do a similar deal for Narso to help support the Omeros stock price?

***********************

U.S. to buy about 1.7 million courses of Merck's COVID-19 treatment for $1.2 billion
1 hr ago

(Reuters) -Merck & Co Inc said on Wednesday the U.S. government has agreed to buy about 1.7 million courses of the company's experimental COVID-19 treatment, molnupiravir, for about $1.2 billion, if it is authorized in the country.

Molnupiravir is an experimental antiviral therapy Merck is developing with Ridgeback Biotherapeutics for the treatment of COVID-19 patients who are not hospitalized.

The drug is currently being assessed in a late-stage trial for its potential to reduce the risk of hospitalization or death.

Merck said it expects to file for the emergency use authorization of molnupiravir in the second half of 2021 at the earliest, pending favorable results from the trial.

The drug is administered orally in capsule form every 12 hours for 5 days and a treatment course contains 10 doses in total.

Merck expects to have more than 10 million courses of therapy available by the end of this year and said it was in discussions with other countries interested in advance purchase agreements for molnupiravir.

Merck has decided to focus on its drugs for COVID-19 after two vaccines failed to generate desired immune responses, prompting it to abandon the program in January.

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Re: Narsoplimab, MASP2, Lectin Pathway & COVID

I can only guess.

1. Omeros is not capable of delivering that kind of volume in bulk, all at once or even in 3 or 5 lots.
2. Omeros likely would not sell a course of narso (4 to 10 infusions) for ~$1500 each, much less for the whole course (because the cost of the drug is much higher (and production must slower) than an an antiviral.
3. Merck owns manufacturing facilities and OMER doesn't.
4. The govt. seems focused on reducing the risk of infection or the severity of the infection, probably to get the antiVaxxers protected instead of being content to allow Darwin to act.
5. I don't think it is a high Govt. priority to get a cure, which says to antivaxxers that there is no  need to get mass immunity any more, so you don't need to get vaccination because we will self your lives if you get what you call "the flu".

I note that the State of Washington has been offering people a free joint if they get vaccinated.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: Narsoplimab, MASP2, Lectin Pathway & COVID

https://www.acsh.org/news/2021/06/10/co … ents-15596

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: Narsoplimab, MASP2, Lectin Pathway & COVID

This increases the addressable market for narso for covid (not that we want to see more people in hospital).

Delta variant doubles risk of COVID hospitalisation - Scottish study
Reuters
The Delta coronavirus variant doubles the risk of hospitalisation compared with the previously dominant variant in Britain, but two doses of vaccine still provide strong protection, a Scottish study found on Monday.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

356

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

I have just finished a preliminary analysis of all 17 CV19 patients treated with narsoplimab. I am doing this because I want to understand how many treatments are required to see some noticeable improvement, as required by the ISPY trial as well as the number of doses of narso it takes, to try to get an idea of the cost and amount of narso (although I can only estimate what Omeros will charge per mg).

I am also doing this so that I can estimate how long it takes for the patients to be cured enough to walk out of the hospital.

I have some preliminary results for the patients from BOTH Bergamo groups and the fellow from Lilly.

The number of doses of narso that it took to see measurable improvement ranged from 1 to 8. I think that 8 was the maximum allowed and there were only 2 that needed 8. Keep in mind that treatments were given twice per week, so 8 means 4 weeks of 2 treatments per week.

The treatment that occurred just before noting the observable improvement, like being taken off a respirator, was on average 10.6 days, with a range of 0 (improvement was noticeable shortly after the first treatment) and 27.

On average, it took patients 14 days to show the improvement, with a range between 0 and 42 days. There was 1 who took 42, 2 who took 27 and 1 who took 20. Everyone else took 16 or fewer days to show noticeable improvement.

I have a lot more work trying to organize and analyze the data, but I can characterize what happens to the average patient, so far:

The average person with severe covid, needing assisted breathing, requires a bit less than 4 treatments (as I had estimate before), and they get those treatments over the course of under 11 days. Three days later, on day 14, the doctors can see noticeable improvement.

Applying this to ISPY, which started approximately on March 6th and has been ongoing (25 days in March, 30 in April, 31 in May and 15 in June) 101 days, there has been plenty of time for EVERY cohort to show improvement as long as they started June 1st or earlier.

The data also suggests, to me at least, that by the end of March, it should already have been obvious that narsolimab works, in that the patients improve. That means that the number of subsequent assignments of patient to each of the different arms of the trial (each one using a different drug), a larger proportion of the available new patient pool should have been allocated to narsoplimab.

I presume that patients were allocated weekly because it makes more sense to start treating them asap, once they volunteer, to try to reduce their suffering. I can estimate that the average allocation to each arm assuming none of them showed efficacy signals was 5 per week. So assuming April started the increase in assignments to narso, we can estimate:

Month Weeks patients
March...3........15 all with results
April.....4........26 all with results
May......5........35 all with results
June.....2........16 none with results given it takes 14 days (or possible half with results if treatment started on June first.

So is 66 patients with result enough to prove that there is sufficient progress with narsoplimab?
Of course, my estimate of 66 could be far off.
There is some reason to think that they started off with the average arm getting an average of 10 new patients each week, because ISPY said they were doubling their patient intake, or were intending to do so. Then again, when the number of severe cases in the USA were declining, perhaps the trial patient intake declined, too.

I still have more to look at on the patients and will update you when i have something interesting.
The sooner we see results, positive results, the faster this share price weakness will be turned into strength and the greater chance Omeros can get the govt. funding to produce massive amounts of narso to be available if/when a EUA is issued by FDA.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: Narsoplimab, MASP2, Lectin Pathway & COVID

In my model of the ISPY trial we already have over 125 patients who should have responded with improvement.

If/when narso is proved to work, the way ISPY works is that a "winner" GRADUATES.

Read about Graduation: https://quantumleaphealth.webflow.io/me … u-patients

Graduation is when a drug that tests significant is graduated from one of the experimental arms to be added to the CONTROL arm. Put more simply, the old control arm is discontinued and the new drug (narso) arm, becomes the control.

I presume that OMER has to agree to this and would be unlikely to do so because it would would using narso up.... UNLESS FDA gives it a VERY fast EUA and the Govt. funds production.

This would be a HUGE announcement: NARSOPLIMAB BECOMES SOC IN ISPY TRIAL
This is what the adaptive trial design is meant to do,

I wonder whether Omeros had to agree to this to get into the trial.

If Quantum Leap wants to do this (and I bet they want to incorporate the first drug that proves successful) they will have to help arrange the conditions that OMEROS would accept.

Yet Greg says that he has been kept in the dark.
So we must assume this has yet to happen and if it did, Quantum Leap is arranging a package to present to OMER when Quantum Leap reveals the results to OMER....but obviously before they say anything publicly.

IMO is has to be a joint decision before an announcement of success, because it won't look good for either party, otherwise.

I may ask Greg if he agreed to this, but surely he will not tell me.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

358

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

I have asked Greg... and he's called me to discuss the subject of "graduation".

His understanding did NOT include the important part of it (that I was discussing above) and he admits that I may understand this more than he does. He read me from the trial treatment protocol and the number of patients, but not the "adaptive" part of the overall trial. He's correct in what he read to me, but the GRADUATION is a separate subject and is about what happens AFTER a drug is found to be a SUCCESS.

I told him I will send him some documentation.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

359

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

Alan Robert Ross wrote:

I presume that OMER has to agree to this and would be unlikely to do so because it would would using narso up.... UNLESS FDA gives it a VERY fast EUA and the Govt. funds production.

i must be missing something - so a successful trial is bad because it uses more of the drug? the price bump from the announcement should fund whatever extra narso they need once the "graduate."

360

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

Either I mis-explained or you misunderstand, Steven.

First, here is the relevant quote from Quantum Leap, which sponsors ISPY:

The I-SPY COVID Trial will have up to 4 experimental treatment arms being studied at any one time. Agents can be dropped in or out of the trial without stopping the trial. Each arm will receive a standard-of-care treatment as a common "backbone" which will serve as a control. If therapies are found to be effective, they will "graduate" at which point they will stay in the trial, or if the signal for patient improvement is strong, a successful therapy could become the new standard-of-care when appropriate. New therapies could then be added to the new standard-of-care which becomes the backbone, enabling testing combinations of therapies that may be essential to improve outcomes in this complex disease.

See it here:
https://quantumleaphealth.webflow.io/me … u-patients

Careful reading says (to me) that IF the experimental drug was successful it MAY be added to the Control Arm as part of standard of care and the experimental arm for testing that drug would be terminated.

Just prior to termination of the experimental arm (using narso) patient accrual would have been much higher than accrual  in the average arm because the rules give more patients to the arm that is performing best.

The control arm (with SOC treatment) always accrues the standard number of patients, neither increasing or declining.

IOW the control may add 5pt/week and narso arm 20pt/wk. If the narso arm terminates and narso is added to the drugs in the control, use of narso declines to treat only 5 new pts/week.

But I am pretty sure Greg would have to agree to this.
I presume he would only agree under very favorable conditions:

For example: if the US Govt. would help with manufacturing, FDA would issue a EUA, and perhaps the US Govt. would BUY many thousands of doses.

Just a pipedream so far.
Greg did not seem aware of this possibility.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

361

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

More good analysis Alan and we need Narso to graduate because even if they do temporarily exhaust the supply of Narso.  With them being the only company with a drug that has graduated they would have no problem raising substantially more money at much better terms than they can now.  Nars has to get getting close with IPSY.

362

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

Can't Narso get some of this $3 billion although its technically not an antiviral drug?

***************************************

HHS to invest $3 billion for antiviral pills against COVID-19
Marisa Fernandez
Axios
6/17/21

The Biden administration will invest $3.2 billion to foster the development of antiviral pills to help fight against COVID-19, the Health and Human Services department announced Thursday, with hopes the medication becomes available to the public as soon as the end of this year.

The big picture: Researchers had tested existing antivirals like remdesivir in hospitals on patients with severe COVID-19, but they produced underwhelming results and little to no benefit.

The Food and Drug Administration has given emergency authorization for three monoclonal antibody drug treatment for early COVID infections.

Why it matters: The newly announced program, called the Antiviral Program for Pandemics, looks to close the gap on financial investment and research directed toward COVID-19 treatments and antivirals.

The program will also support research on entirely new drugs that could help respond to future pandemics.
NIAID director Anthony Fauci told reporters at a briefing Thursday the government has a “great deal of optimism that this program will be as successful” as similar federally-funded projects for viruses like HIV and Hepatitis C.
What they're saying: “I wake up in the morning, I don’t feel very well, my sense of smell and taste go away, I get a sore throat,” Fauci told the New York Times. “I call up my doctor and I say, ‘I have COVID and I need a prescription.’”

Details: The funding, which comes from the American Rescue Plan, is aimed at speeding up the clinical trials of a few promising drug candidates.

More than $300 million will be reserved for research and lab support, nearly $1 billion for preclinical and clinical evaluation and nearly $700 million for development and manufacturing through the National Institute of Allergy and Infectious Diseases and Biomedical Advanced Research and Development Authority, the agency said.
Noteworthy: The Biden administration announced last week it's buying about $1.2 billion worth of Merck's experimental COVID pills Molnupiravir.

The drug is taken every 12 hours for five days. It has not been approved, but appears to help newly diagnosed, non-hospitalized COVID patients.

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Re: Narsoplimab, MASP2, Lectin Pathway & COVID

It is a long shot, Larry.
If they succeed in ISPY THEN there is a chance, probably a good chance.
And if they become part of the SOC in ISPY there would be a VERY good chance of manufacturing support, an order from the Govt. and a fast EUA from the FDA. At least that all is made more likely.

The email groupI am in were discussing the NYTimes article about wasting Billions on more Anti-Viral.
These are Omeros investors and they don't get it.
I wrote the following to hit them over the head with the reality.

Perhaps it will help if we read it every once in a while.

Anti-virals do not work except if they are taken within the first day or two of infection.

Acyclovir was one of the first effective antivirals and has minimal efficacy after 2 days of post-infection.

Remdesivir is another failed antiviral, for Covid, even though it is still being used.

Big Pharma pushes anti-virals.
Even the article notes that the pills are for early in the virus.

The people who are wasting this money are doing so foolishly. Just about every company that has an antiviral has tried theirs in hopes of making a fortune. The authorities are so addicted to Hopium they can't think straight... or they think the great unwashed out there need to be fed Hopium.

They can't put 2 and 2 together and get ZERO.

A. If you can't treat within 2 days, antivirals don't work well enough.
B. Covid-19 symptoms show up, at the earliest, after 2 days.

So tell me which people without any symptoms are going to take the new antiviral? or any antiviral.

The average person who gets the virus and has symptoms, first shows those symptoms some time before the 8th or 10th day. But many people never have noticeable symptoms. They have the Virus and can give it to other people.

Antivirals have a Mode of Action that has Face Validity (i.e. it looks logical to the average person) so they engender Hope to the uneducated masses and present a possible winning lottery ticket for any drug maker that gets the authorities to approve their antiviral.

Narsoplimab is a new drug, the first in a new class of drugs, for a part of the immune system >95% of people have never heard of (complement, much less the Lectin Pathway).

Everyone KNOWS that the virus kills people.
So it is logical to fight it with an Anti-Viral drug.

But in fact, the virus does NOT kill you.
The body's maladaptive response to the endothelial damage is what causes the fatalities.

Narsoplimab takes care of this maladapted immune response, but does not have Face Validity because people do not know the biology.

Even some Omeros shareholders fail to understand the biology.

And, so far, there are no completed controlled trials that prove narsoplimab efficacy.

This is one of the reasons why the popular press does not cover the promise of narsoplimab.
Yet.

If you do not understand the biology or the reasoning I have outlined, some more research would probably be a good idea so you can explain it to other potential Omeros investors.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

364

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

I have been contemplating some sort of public article on the Omeros Covid19 results, based upon my compilation of all the existing public data on each individual. I figure it can't hurt and I already spent the time on the data.

I think I already have offered a copy of the data spreadsheet to those of you who want it (the individual data and my analysis of the data and there were not takers. I may put that sheet on Google drive to share it and include anyone in a small WhatsApp group started by my Britalian friend...or something like that (but I haven't come to a decision).

So I am soliciting your opinions about any of this, this morning, because I am going to clean up the sheet to make it presentable and while I do that, I will decide what to do.

It is fine with me if you are not overly interested in anything other than the conclusions (which are that ISPY should already know narso works... but we don't know how good the data needs to be before they make that a public conclusion).

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

365

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

I am thinking there would be no downside to making the CUP data synthesis public in some form, although perhaps my description of the data, not necessarily my raw transformation of the patient by patient data...because the shorts and bashers could not cherry pick negative outliers if they only had group data.

As I said in the last post, I solicit your views on this.
In today's data mining I was looking at total #doses per patient and days to last dose (given dose 1 is given at day ZERO).

This is useful in projecting the average cost of narsoplimab per patient. It also brings up a question about why some patients got less than the maximum number of doses even though they remained in the hospital. It also gives me the potential to look at some relationships between when the patients undergoing different breathing support were dosed, or not.

Mean doses for the 15 survivors was 6.4 and median was 7.
Range was between 5 and 8.
3 patients got only 5 doses and 4 got 6, but 7 got all 8.

From the Lilly description, I don't think  the patient needed all 8, and if they had stopped earlier, MASP2 would have already been shut down.

IOW, research needs to determine how many treatment shuts down MASP2 and for how long. We know (or believe) that once MASP2 is shut down, we rely on the patients' (CV19, TA-TMA, IgAN....whichever) recuperative powers to repair the endothelium. If MASP2 level is close to zero, it should not be necessary to continue to administer more MASP2 inhibitor until the amount of MASP2 is almost high enough to start causing more damage.

IMO knowing this may cut down on the amount of narso needed, to be effective, reduce the cost to the  healthcare system so less severely ill patients could be treated and avoid progression... and reduce the pressure to reprice narso lower... across indications.

So I wonder what could they have been measuring in blood that directly or indirectly can be used as an indicator of no effective MASP2?

Omeros surely has the pharmacokinetics of narsoplimab... after all they just issued a PR about the PK of OMS906 (how much drug is needed to send MASP3 to near zero and how long it lasts, so they know how frequently they need to dose.

A SINGLE DOSE of 906 at 3mg/kg IV kept MASP3 UNDETECTIBLE for FOUR weeks.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: Narsoplimab, MASP2, Lectin Pathway & COVID

Hi Alan. I don’t have internet here, nor email, just cellular data. Otherwise I would have asked to be sent your data. I think putting your data/conclusions on your friends blog is a good idea. Our stock needs all the positive publicity it can get. What could be wrong about writing the truth about Narsoplimab? Tailoring your post to give the shorts/badgers minimal opportunity to negatively reply is also a good idea. Thanks for your work.

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Re: Narsoplimab, MASP2, Lectin Pathway & COVID

Thanks for sharing your view, Avi.
It is not a friend's blog, but a small working group of people actively researching Omeros and things related.
To make it generally available, I will do it one way or another, if it seems advisable.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

368

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

Alan, sorry for delayed comments. You're doing terrific analyses and posting them could be very worthwhile.

I like what you wrote to hit the group over the head.

EE: Narsoplimab takes care, not "take case".

If you send me taht Excel spreadsheet, I'll check it out.

TIA!

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Re: Narsoplimab, MASP2, Lectin Pathway & COVID

Thanks Bill.
I do not know what you mean about this: "I like what you wrote to hit the group over the head."

I spent a lot of time today searching through all the earliest narsoplimab PRs that OMER published, which started in 2013.

I found that in the beginning OMER was bragging how a SUB-CUTANEOUS dose of narso would last weeks...kind of like what they are saying now about OMS906.

And, in fact, for aHUS they went with SubQ dosing... but not weekly.
Every Day.

And then for IgAN and HSCT-TMA they went twice weekly IV Infusions, the same as for CV19.

You should be thinking WHY did he do that.

I did it because the standard treatment for CV19 is supposedly twice a week for 4 weeks (total 8).
But some people only had 5 or 6 infusions (2 per week). Median was 7, so half had less then 7.

And it looks to me that some did not need as much narso as they were given. So it was a logical question about the PK of narsoplimab:

How much do they need to give a patient to stop MASP2 from triggering the Lectin Pathway?
and
How long does that dose last?
***********************
Why is this important?
If OMER could use half the narso to treat each CV19 patient, the cost would be cut in half and the narso stockpile (which is not large enough to treat many people with cV19, plus run the ongoing trials, and reserve enough narso for the TA-TMA launch) would treat twice the number of patients.

Using less narso for each CV19 patient would reduce the cost per patient and would have less of a price lowering effect on the amount Omeros could charge to treat HSCT-TMA which saves about $1M in healthcare costs spent trying to keep patients who die from HSCT-TMA, alive.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

370

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

Alan Robert Ross wrote:

I do not know what you mean about this: "I like what you wrote to hit the group over the head."

I was referring to the comments you made, and reposted to us, in post #363 above which you prefaced with, "I wrote the following to hit them over the head with the reality."

371

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

Ahhh, about the bad track record of anti-virals.
Too much face validity without efficacy in Covid because of incubation periods and so many cases with mild symptoms.
Thanks for explaining

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

372

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

I think getting the information out to the general investing public to help support the stock price would be good.  At this point Tipsters have had plenty of opportunity to get as many shares as they wanted.

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Re: Narsoplimab, MASP2, Lectin Pathway & COVID

Thanks for sharing your view, Larry.

The way to make it non-controversial but obviously positive is to just present the synthesis of the data and only refer to the speed at which the CUP suggest that it should be evident that the drug works.

I could also show the ISPY enrollment model but that is full of assumptions that skeptic can attack or not believe.
Of course, we all are wondering what is taking so long. More than 60 patients should have already been discharged accoring to the CUP data.

I point out (again) that the Gilead statement that their drug has "real world" use that shows that it works, is certainly also true of Omeros' narsoplimab.

So what do you think of not presenting the ISPY enrollment model?

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

374

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

I would vote for staying away from ISPY because there are too many unanswerable questions that we retail investors cannot answer, and which the shorts and bashers would love to answer themselves.  Unless you could point to unquestionable conclusions...All I know for sure re ISPY is that Narsoplimab has not been kicked out of the trial so far, and that enough time has gone by to conclusively prove that Narsoplimab works. My feelings are that Omer, ISPY, and who knows how many Government agencies are tied in a knot trying to figure out how to bring Narsoplimab to market. It may take multiple compromises before everyone can move forward. I have no public evidence of this of course, but it makes sense to me at this point in time.

375

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

alaskasalmonfisher wrote:

I would vote for staying away from ISPY because there are too many unanswerable questions that we retail investors cannot answer, and which the shorts and bashers would love to answer themselves.

I agree with Avi.

376

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

You must be right because you agree with me. smile

I will likely say something like with the median #days to improvement occurring at the 10 day market, half the patients treated so far were better before they had the 4th narso treatment.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

377

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

just sent:

Good morning, Greg.

I accessed the "Coronavirus-related stocks" on the CNBC website
https://www.cnbc.com/coronavirus-related-stocks/

And found that ALXN is listed, but that Omeros is not listed. I think this should be fixed and that Omeros needs a stronger public recognition profile. Few get Omeros news, apparently.

Best....
Alan


MARKETS
CORONAVIRUS-RELATED STOCKS

    US
    .COVID-19 INDEX
    CORONAVIRUS LATEST NEWS

SYMBOL      NAME      CHANGE      %CHANGE
ABT     Abbott Laboratories     +2.16     +1.95
ABBV     Abbvie Inc     +0.99     +0.87
ADPT     Adaptive Biotechnologies Corp     +0.24     +0.59
ALXN     Alexion Pharmaceuticals Inc     +2.06     +1.15
ALNY     Alnylam Pharmaceuticals Inc     -0.665     -0.381
AMGN     Amgen Inc     +2.34     +0.98
APLS     Apellis Pharmaceuticals Inc     +0.19     +0.29
AZN     AstraZeneca PLC     +0.92     +1.59
BDX     Becton Dickinson and Co     +0.68     +0.28
BIIB     Biogen Inc     -16.16     -4.345
BNTX     BioNTech SE     +0.845     +0.37
EBS     Emergent BioSolutions Inc     +1.25     +2.08
LLY     Eli Lilly and Co     +18.655     +8.59
FUJIY     Fujifilm Holdings Corp     +1.64     +2.27
GILD     Gilead Sciences Inc     +1.275     +1.91
GSK     GlaxoSmithKline PLC     -0.08     -0.201
HOLX     Hologic Inc     +0.66     +1.02
INO     Inovio Pharmaceuticals Inc     +0.225     +2.59
JNJ     Johnson & Johnson     +0.915     +0.56
LH     Laboratory Corporation of America Holdings     +0.14     +0.05
LZAGY     Lonza Group AG     +2.146     +3.05
MRK     Merck & Co Inc     +0.745     +0.99
MESO     Mesoblast Ltd     +0.09     +1.07
MRNA     Moderna Inc     +6.73     +3.17
NNVC     NanoViricides Inc     -0.08     -1.683
NVS     Novartis AG     +0.51     +0.552
NVAX     Novavax Inc     +2.045     +1.06
PFE     Pfizer Inc     +0.18     +0.46
QGEN     Qiagen NV     +0.87     +1.84
REGN     Regeneron Pharmaceuticals Inc     +8.67     +1.64
ROCHE HOLD     Roche Holding AG     +0.7     +1.52
SNY     Sanofi SA     +0.45     +0.86
SRNE     Sorrento Therapeutics Inc     +0.18     +1.99
TMO     Thermo Fisher Scientific Inc     +3.41     +0.69
VIR     Vir Biotechnology Inc     +1.03     +2.19
DGX     Quest Diagnostics Inc     -0.14     -0.108

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

378

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

I received a reply a few minutes ago that he'd "try to get this fixed".

IMO this suggests he agrees that the company should have a higher profile.
He did not have to reply, at all.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

379

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

I assume any media would like to be the first to break a story. If CNBC was smart they’d talk to Greg, and come out with a story about Narsoplimab.

380

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

I'd hope that Greg would get himself interviewed or go on Cramer or both.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

381

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

That sounds good too. Greg should turn himself into a rock star. My most realistic hope is that the Reddit people start pumping the stock once news comes out.

382

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

I hope you are not going to hold you breath in anticipation.
smile

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

383

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

"Greg" and "rock star" don't fit together IMO.  I think he's a brilliant scientist, knowing exquisite detail about "all things OMER" but he's a very monotonic speaker most of the time, suppressing (deliberately, IMO) excitement when speaking about really important things.

384

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

I agree with you, Bill. His accomplishments are pretty outstanding.

385

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

I just sent the following to Greg, having contemplated the difficulty in getting FDA approval to treat Long Covid (LCV), given that there are so many organ systems potentially causing problems in LCV.

I presume someone is working on addressing LCV at Omeros and I don't really expect a reply.
I also know that the OPTIMUM dose for LCV may be much different that the dose used in ISPY, but that can be worked out in a subsequent trial.

I want to ensure he's thinking about doing it my way, to start, because my way is as close to zero cost as you can get.
======================
Good morning, Greg.

I was contemplating the difficulty in getting FDA approval for LongCV prevention, which is what your data so far suggests narso can do. Given the variety of LCV symptoms, a global (rather than symptom by symptom) indication would be very valuable and save time + money, assuming the FDA would allow it.

While I understand there would be complications in extending the patient monitoring from 2 months (in the current endpoints) to 6 (or more if necessary) in the ISPY trial, doing so for narso and controls would be inexpensive and relatively quick. It would require no more narsoplimab, for example. As long as you could get access from ISPY, it might even suffice to just have access to patient medical records for an added 4 months (or more).

Given the ongoing mutations and vaccinations, LCV will be an increasingly expensive addition to the healthcare landscape needing a solution. Any company providing a solution will help a lot of people, make a lot of money and become famous, creating a halo effect for their other efforts and share price.

It also provides a good reason to be in touch with ISPY.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

386

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

OMEROS COVID-19 NARSOPLIMAB DATA
PART 1: DATA TO DATE
Alan Robert Ross and Peter Cowling
trustintelligence.com
July 2, 2021
 
TERMS
CUP - Compassionate Use Program 
Narsoplimab - a monoclonal antibody, MASP2 inhibitor
CV19 - Covid-19
ARDS - acute respiratory distress syndrome
QLHC - Quantum Leap Healthcare Collaborative
CPAP - Continuous Positive Airway Pressure apparatus

SUMMARY
- Omeros is running a CUP that makes Narsoplimab available to severely ill CV19 patients with ARDS.
- Only patients who are very ill and have not responded to conventional therapy are eligible for enrollment.
- Results are available from 3 sources, for a total of 17 CV19 patients.
- Narsoplimab is now being used in a Phase 2 CV19 trial sponsored by QLHC.

Part 1 combines the 3 datasets to get a better picture of how Narsoplimab has worked in a real-world setting.
Part 2 applies the Narsoplimab CUP dataset to the structure of QLHC’s independent Phase 2 “I-SPY” trial.

NARSOPLIMAB & CV19
Narsoplimab does not kill the CV-19 virus.  What it does is manage an overreaction by the body's immune system, in its attempt to fight it off.  When the CV-19 virus first arrives, patients’ immune system has no prior knowledge of how to fight it.  The body therefore deploys a general purpose immune response mounted by what is known as the "complement system". 

The complement system tries to fight the virus off long enough for other parts of the immune system to develop a tailored response, designed to kill CV19, specifically.  Unfortunately, in some patients, the virus caused the immune system to overreact.  The overreaction doesn't help... it makes the situation far worse.  The overreaction itself is what triggers patients to become severely ill; at risk of dying (and later suffering from LongCovid).  ARDS is the most prominent risk, but every organ has been shown to be compromised by CV-19, and all of them lead back to the immune overreaction that narsoplimab can eliminate.

Many other companies have had high hopes that their drugs could manage overreaction of the initial immune response; with drugs that address the ‘cytokine storm’ or ‘IL-6’, for example.  There have also been attempts to address the coagulation issues & ease breathing problems; to eliminate the damage caused by the immune overreaction.  All of these approaches may or may not turn out to help reduce symptoms, but none of them hold the key to them.  Narsoplimab addresses the problem in a unique place in the immune system and both 

- turns down the body's over-active immune response
- addresses the coagulation problems at their source 

CUP BACKGROUND
The data shows that, before Narsoplimab treatment commences, all patients are having significant problems breathing. Many are anesthetized, intubated and ventilated - meaning they are in critical condition. Further, the patients have failed normal treatment, and have pre-existing conditions. Overall, all patients have a very high mortality risk. 

COHORT 1: During the winter of 2020, Papa Giovanni Hospital in Bergamo, Italy treated six patients.
- The day before the initial Narsoplimab treatment all patients were on CPAP
- All 6 (100%) recovered, were discharged and had no LongCovid symptoms at 6 month followup
- Only 47% recovered in a control group using similar patients assigned by the same lead investigators

COHORT 2: On May 28, 2021, Omeros reported the results of a second CUP cohort.
- 9 patients were intubated on the day prior the first treatment
- 1 patient was first treated on CPAP
- all patients had a range of comorbidities & 8 of the 10 patients survived and were discharged.

LILLY PATIENT: In spring of 2021, Kneirman et al. published a case study of a CV19 CUP treatment of a severely-ill, ventilated employee of Omeros-competitor, Eli Lilly.
- the patient had failed multiple treatments and was intubated for 7 days prior to 1st narsoplimab dose
- the patient recovered and went back to work.

https://scontent.fpac1-2.fna.fbcdn.net/v/t1.6435-9/210197767_1896708503837725_9028258188013128053_n.jpg?_nc_cat=104&ccb=1-3&_nc_sid=730e14&_nc_ohc=Iv3KtrR12mUAX_J_HnY&_nc_ht=scontent.fpac1-2.fna&oh=e360b336254bc408e0ac8e1aadb21aee&oe=60E2C11E

DATA
I have compiled the data that describes the milestones during the treatment of these patients and present it, patient by patient, so you can see it for yourselves. Source data came from publicly available charts, published by Rambaldi et al. [https://doi.org/10.1016/j.imbio.2020.152001], Omeros Annual Meeting Presentation [June 11, 2021], and Knierman et al. [J. Allergy & Infectious Disease (2021: 2(1):24-28].

SURVIVAL RATE: Fifteen of the 17 patients (88.2%) fully recovered. No signs of LongCovid have been reported to date. Regrettably, two members of the most severely ill group, Cohort2, died during treatment.

Patient 8 (in the Table) was 76 years old, and died from complications of pre-existing cardiomyopathy.  The patient died nine days after treatment started, and received only three of the planned eight doses of Narsoplimab. 
Patient 11 was 68 years old.  He was intubated for 13 days before Narsoplimab was first administered.  He died 27 days after treatment started, of multiple organ failure. Note that, generally, death rate in CV19 is highly correlated with being intubated - particularly intubation duration.

CRUCIAL ENDPOINTS
Two important CUP milestones were 1) how fast patients improve and 2) how long before they were discharged from hospital.

IMPROVEMENT: ‘improvement’ here is defined as going from a more extreme form of breathing assistance to a less extreme type of assistance. For example, a patient was considered to have improved if they had their breathing tube removed, were brought out of anesthesia, and were put on a CPAP device. Someone who changed from assisted breathing to breathing on their own would be a clear improvement. Applying this qualitative approach, we find:
- 15 patients improved and were discharged.
- The median number of Narsoplimab treatments before first improvement was three.
- The median number of days it took for improvement was eight.

DISCHARGE 
‘Discharge’ is defined by the patient leaving the hospital. In effect, this means that the patient has recovered from the effects of CV-19 enough to no longer need hospital-level medical care.

- 15 patients were discharged between 15 and 91 days after treatment started.
- The median number of days to discharge was 33.
- The median number of Narsoplimab doses before discharge was seven.
- Only seven patients had all eight doses to recover.
- The median time until the last dose of narsoplimab was 19 days. The patients’ subsequent recovery implies that, by this time, Narsoplimab had done its job.

CLINICAL SUMMARY
Of the patients who survived:
- half of them started improving after only three treatments, a bit over a week after their first dose of Narsoplimab.
- 11 of 15 only needed two weeks or less of treatments before they improved.
- 11 of 15 left the hospital in 34 days or less, and seven of those left in four weeks or less.

IMPLICATIONS FOR NARSOPLIMAB PROGRESS IN THE I-SPY TRIAL
Narsoplimab is part of the ongoing I-SPY trial that seeks to finds therapeutic agents that can save the lives of people with severe cases of CV19, at risk of dying. Narsoplimab started in the trial in early March 2021, so it has been treating a succession of patients for about 17 weeks. Treatment only lasts a maximum of 4 weeks and QLHC only allows a maximum of 125 patients for each drug tested.

The CUP data presented and discussed in this article indicates that people treated with Narsoplimab
1. usually start to improve in their second week of treatment and
2. are likely to be discharged within 5 or 6 weeks

This suggests to me that all or almost all of I-SPY trial’s Narsoplimab patients have already improved,  recovered and gone home. Unless there is a surprise press release very soon, the second part of this article, next week, will tackle this question in more depth.

Note: Hat Tip to WT for his valuable help in the various stages of this article.

The foregoing is not investment advice. I own shares in Omeros and no one has compensated me for writing this article. © 2021 by Alan Robert Ross

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

387

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

NYTimes story illustrates the need for narso
-----------------------------------------
The Rationing of a Last-Resort Covid Treatment
By Sheri Fink
NYTimes
While ventilator shortages have been largely averted in the U.S., this lifesaving therapy is scarce. How to choose which critically ill patients get it?

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

388

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

Visitors still coming for the articles. Since the last was posted, there have been 630 views.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

389

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

I am wondering about this quote:
In light of our present results, and the encouraging performance of our clinical candidate MASP-2 inhibitor Narsoplimab in recently published clinical trials, we suggest that the targeting of MASP-2 provides an unsurpassed window of therapeutic efficacy for the treatment of severe COVID-19.

because there is only 1 publication  and it is NOT a clinical trial. It is the CUP from Bergamo.

https://www.frontiersin.org/articles/10 … 00_ARTICLE

Front. Immunol. | https://doi.org/10.3389/fimmu.2021.714511
Lectin Pathway Mediates Complement Activation by SARS-CoV-2 Proteins
Youssif M. Ali1,2*, Matteo Ferrari1, Nicholas J. Lynch1, Sadam Yaseen3, Thomas Dudler3, Sasha Gragerov3, Gregory Demopulos3, Jonathan L. Heeney1 and Wilhelm J. Schwaeble1
1Department of Veterinary Medicine, School of Biological Sciences, University of Cambridge, Cambridge, United Kingdom
2Department of Microbiology and Immunology, Faculty of Pharmacy, Mansoura University, Mansoura, Egypt
3Omeros Corporation, Seattle, WA, United States
Early and persistent activation of complement is considered to play a key role in the pathogenesis of COVID-19. Complement activation products orchestrate a proinflammatory environment that might be critical for the induction and maintenance of a severe inflammatory response to SARS-CoV-2 by recruiting cells of the cellular immune system to the sites of infection and shifting their state of activation towards an inflammatory phenotype. It precedes pathophysiological milestone events like the cytokine storm, progressive endothelial injury triggering microangiopathy, and further complement activation, and causes an acute respiratory distress syndrome (ARDS). To date, the application of antiviral drugs and corticosteroids have shown efficacy in the early stages of SARS-CoV-2 infection, but failed to ameliorate disease severity in patients who progressed to severe COVID-19 pathology. This report demonstrates that lectin pathway (LP) recognition molecules of the complement system, such as MBL, FCN-2 and CL-11, bind to SARS-CoV-2 S- and N-proteins, with subsequent activation of LP-mediated C3b and C4b deposition. In addition, our results confirm and underline that the N-protein of SARS-CoV-2 binds directly to the LP- effector enzyme MASP-2 and activates complement. Inhibition of the LP using an inhibitory monoclonal antibody against MASP-2 effectively blocks LP-mediated complement activation. FACS analyses using transfected HEK-293 cells expressing SARS-CoV-2 S protein confirm a robust LP-dependent C3b deposition on the cell surface which is inhibited by the MASP-2 inhibitory antibody. In light of our present results, and the encouraging performance of our clinical candidate MASP-2 inhibitor Narsoplimab in recently published clinical trials, we suggest that the targeting of MASP-2 provides an unsurpassed window of therapeutic efficacy for the treatment of severe COVID-19.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

390

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

http://www.trustintelligence.com/viewto … 8273#p8273

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

391

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

Overnight the hits on the last public article, about the CV19 CUP data as interpreted according to the endpoint of the I-SPY trial has hit over 1000 views.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

392

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

Excellent work on that piece Alan.  Pleased to hear it's being more widely read.

393

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

Thanks Ed. I am glad because the continued hits indicates interest in narso and Omeros. I have not done any more PR for the article and I am thinking of Tweeting the data chart showing how the eligible CUP patients would have fared on ISPY.

We are now at about the point in time that my patient accrual assumptions would predict that the final patient would have provided all the required data. I don't expect to have perfectly modeled it, but it certainly suggests we should here (the proverbial) "soon".

Then again, it is possible that ISPY has already told Greg and he is holding onto the information
- until he gets more details
- until ISPY is ready to comment on the data analysis
- until Omeros has gone through the data to say things correctly in a PR

But I presume that he doesn't want to hold onto material news like this, for long, and risk a leak.
And a leak could happen from the ISPY or OMER side.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

394 (edited by dorcse 2021-07-24 10:06:48)

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

Agree with all the possible reasons for holding data.  Could we add still finalizing/securing funding for drug production and distribution as another?  I don't know that it would cut it to announce great data without details about how the drug will be made available?

395 (edited by Alan Robert Ross 2021-07-24 10:48:00)

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

That certainly could be a reason, since I am pretty sure it is a reason why Greg suppressed news of treating CV19 so successfully, for so (too, IMO) long.

As in the recent post I did in the Pandemic
http://www.trustintelligence.com/viewto … 8293#p8293

my focus is the Long Game.
IMO Greg has been playing the long game for years. Shareholders suffer in the short run because of this but someday, hopeful they will profit... the few who still own the stock... because most of those who suffered will have exited along the way.

I am talking about Sequelae.

IMO the long game for Omeros should be treating people with sequelae and preferably, treating people so they do NOT GET SEQUELAE.

I have an idea that if you knock out the lectin pathway activation and give the endothelial system a change to heal, you will avoid sequelae and, if you get this treatment before the disease gets severe, like as soon as starting to have breathing problems, you will eliminate (almost?) all severe cases of CV19.

After all, it is not the virus that directly causes the deaths.

Tell me the price of narso for HSCT or Igan makes any difference if it is smart to treat 100s of millions of people with narsoplimab!

If there are Billions of people who would want narso to preclude death and Long Covid you could sell narso for a 25% to 50% markup and still easily make $50 or $100 Billion a year.

And along the way, I am guessing that treating people with narsoplimab would lead to counter-inflammation effects that will reduce overall deaths from cardiovascular, kidney and other kinds of inflammation-caused diseases.

Of course, Omeros would have to speed up its development of narsoplimab in a pill form or injection if necessary. Infusions take too much time and cost more money to administer.

I suppose part of the problem to getting narso as a treatment for sequela is getting the needed data.
Narso-treated patients need to be tracked for 6 months to a year to prove lack of sequelae. To do a trial just for sequelae, you need to burn through a lot more narsoplimab and Omeros does not have the spare cash to do that. So they need to tract past-treatment for everyone they treat for other reasons (like in the cup or ISPY), also tracking a matched control group who did not get narso)... and try to use that data to get FDA approval (to treat or prevent sequelae) of some kind.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

396

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

The few.  The proud.  The Omeros shareholders.

Hey I agree with you Alan on greatly broadening the application for Narso to prevent Covid sequelae.

Can I add that along with your idea that giving Narso for Covid and letting the endo system heal, there MAY be value in giving all/most HSCT patients Narso?  What are the chances that all the brutal pre and post treatment regimens are NOT causing some degree of endothelial damage and complement activation in this group?  Sure this theory has to be proven, but if it did prove out and treatment with Narso could lead to better outcomes in most HSCT patients, what kind of market opportunity does this represent, assuming Narso is priced right?

I've said all this before,  I know.  Just wishful thinking?

397

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

US healthcare is not big on prevention... and prevention trials are more expensive than treatment trials because N is larger and you have to follow them longer.
The resulting data are less robust (with severed HSCT you don't need stats, you can just count 9 died out of 10 versuse 1 died out of 10... not so clear cut with a prevention trial (50/500 died with narso and 62/500 died without).

I think Omeros' tactic is to move to treating all patients with at least 1 high risk factor for severe HSCT-TMA instead of waiting for Severe TMA. I don't know what the pitch is in the BLA so we await to see the full description of the INDICATION on the approval. If the cost of treatment is reasonable...(my guess) $200k or less, it could be cost effective to give narso to all transplant recipients and, at the same time, reduce the risk of GVHD.

But the extra transplant-related cash earnings will be a drop in the bucket compared to narso for CV19 AND its Sequelae (especially by pill or a shot IM or subQ.   

I have written a note to Greg, which I really don't expect a reply to, asking for him to outline his longterm plan for narso in CV19 and sequelae. If he responds he will give me the information he has already made public, but I asked some specifics and told him that for shareholders to appreciate his vision, he needs to clue them in on what the Long Game really IS.

May not help, but I figure that giving it a try can't hurt.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

398

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

Thanks for the efforts Alan!  Always greatly appreciated!

399

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

As is the feedback

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

400

Re: Narsoplimab, MASP2, Lectin Pathway & COVID

A review article about complement system and CV19, including the various mechanisms and data showing that the Complement system is important. Narsoplimab is mentioned once, as are other drugs in trials. MASP-2 is mentioned more prominently because it is important in the body's response to CV19 (and only Narso affects MASP-2).
https://www.dovepress.com/complement-in … rticle-ITT

One of the authors is doing research on CV19 and ALXN (AZN) drugs and gets support from them, but the paper isn't overly biased. Note that there are many non-Lectin Pathway, non-MASP2 Complement inhibitors, so there is more coverage of these than of the lone MASP2 inhibitor.

In case you forgot, the other complement pathways, the Classical and Alternative, do not have the ability to control the hyper-clotting problem, much less shut it off, like inhibiting MASP does.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.