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But don't forget Bill - "IMHO" could be just a cover.  One never knows for sure.  But I would bet that it's his personal opinion, not            inside information he's passing off as his personal guess.  I've got more to say about this type of thing on the "Civil Unrest" thread, if I can find it.

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Re: Narsoplimab generally

Baffoe also was involved in raising money for Omeros in the early years, I think.

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

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Re: Narsoplimab generally

Correct, but only in the early years.  When Greg turned elsewhere, Joe was pissed. Understatement. NOT FOR DISTRIBUTION BEYOND TIPS!!!!!

I was more than a tad surprised to see him on ST, posting favorably.

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Is, or was, he an Investment Banker or VC, or a fund manager making early stage investments?  These people (e.g., Baker Bros) seem to have thin skin if companies don't take their money on their terms.  At the end of the day though it needs to be either about the money, the control, or the science.  Which category did he fall into?

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Joe was with an local/regional firm. Based in Chicago I think. Growing companies outgrow their initial investment banks and backers... and investors in most cases.

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

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I have been told by a European contact that Steve Brozack, one of the analysts covering OMER, had something to do with filing the BLA. I find that odd. I asked for more info. Brozack's analysis and CCall questions certain suggest he likes  Omeros a lot. This was brought up because one of Brozack's friends is Rick Bright, one of the founders of Operation Warp Speed. 

This background story is an illustration that some of the Bio/Pharma people in Washington did (and do) know about what narso did in Bergamo.

Bright was also the head of BARDA who did a pretty good/fast job of apportioning $Billions to attack the virus. He ran out of money fast and was fired for doing his job when he criticized the Trump Administration's negligence on combatting CV19.

But remember that BARDA didn't do anything for OMER while Bright was still there. Instead BARDA gave over 90% of the money to vaccine companies and related things and just a few percent to the search for an effective treatment. 

So with these supposed connections, it still took almost a year to get into an official trial. We don't know whether this Washington was unimpressed or was because Greg did not want to be in a trial BEFORE he made some sort of market deal that would protect narso's financial viability, or because OMER had to produce enough narso to run the trial and have enough left over to be able to treat patients if Emergency Use Approval was given.

The current best-case scenario I have in mind is that Narso is used to treat 20 ventilated patients in week 1 and by week 4, they are all alive and off ventilation.

What will the Independent Monitoring Committee do then?

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

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Update: Brozack did not have anything to do with the BLA. He signed a NDA (nondisclosure agreement) and this has kept him from issuing any reports or upgrading the target since he signed. I presume this means he CAN issue new reports when the info disclosed becomes public.

And the implication of this was that Omeros disclosed things about the CV19 program so that Brozack could help get the ear of Mr. Bright in Washington.

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

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BIOLOGICS LICENSE APPLICATION FOR NARSOPLIMAB IN HSCT-TMA ACCEPTED FOR PRIORITY REVIEW BY U.S. FDA
-- FDA sets PDUFA date of July 17, 2021 --

SEATTLE--(BUSINESS WIRE)--Jan. 19, 2021-- Omeros Corporation (Nasdaq: OMER) announced today that the Biologics License Application (BLA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) has been accepted for filing by the U.S. Food and Drug Administration (FDA). The BLA has been granted Priority Review with an FDA action date of July 17, 2021 under the Prescription Drug User Fee Act (PDUFA). FDA also indicated in its filing letter that the Agency is not currently planning to hold an advisory committee meeting to discuss the BLA.

FDA grants Priority Review to applications for therapies that, if approved, would be significant improvements in the safety or effectiveness of the treatment, prevention or diagnosis of serious conditions. Narsoplimab targets mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of complement, and has received breakthrough therapy designations and orphan drug designations from FDA for each of HSCT-TMA and IgA nephropathy.

"The filing of our BLA by FDA marks an important milestone on the path to commercialization of narsoplimab," stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "There is no FDA-approved product for the treatment of transplant-associated TMA, a frequently fatal complication of stem cell transplantation. We appreciate FDA’s collaborative approach throughout the development of our breakthrough therapy-designated product narsoplimab, and we are committed to continue working closely with the FDA review team to make the drug available to patients who need it."

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I note that Omeros mentions the indication (HSCT_TMA and not something more broad, darn-it). And says they will continue to work with the "FDA review team to make the drug available to patients who need it."

More then just HSCT patients NEED IT, of course.

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

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Good news (at last!) but i am confused. I thought it was on tract to be accepted as a treatment - not on track to to be "priority reviewed" as a treatment.

not that i am complaining, but it sounds like the approval date was just pushed out to july. it took them 60 days to say we will take a look at this in 6 months?

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You have misunderstood the process.
FDA has 2 month to evaluate whether it will ACCEPT the APPLICATION.

Priority Review cuts the time allowed for review from 10 to 12 months to 6 months.

Drugs FDA wants approved fast may be approved before the respective deadlines.

I have seen Priority Review drugs approved in 3 months, 1 or 2 approvals for new indications for already-approved drugs have taken only 2 months.

No ADCOM is scheduled, which means FDA doesn't need outside experts to review the data before approval. This allows early total approval for commercialization.

Any questions?

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

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i guess i did.
one another note, the extra 6 options were never exercised.
at 6 cents, not a big deal.
having the extra 600 shares when it jumps this morning is a nice bonus.

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Sure it!
Boy, whoever had them is kicking themselves, today.

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

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Alan Robert Ross wrote:

You have misunderstood the process.
FDA has 2 month to evaluate whether it will ACCEPT the APPLICATION.

Priority Review cuts the time allowed for review from 10 to 12 months to 6 months.

Drugs FDA wants approved fast may be approved before the respective deadlines.

I have seen Priority Review drugs approved in 3 months, 1 or 2 approvals for new indications for already-approved drugs have taken only 2 months.

No ADCOM is scheduled, which means FDA doesn't need outside experts to review the data before approval. This allows early total approval for commercialization.

Any questions?

Great summary Alan.  I feel we are now at the point  where the value of the rolling BLA will truly be realized.  We don't know how much FDA review has already taken place, but it seems reasonable to assume enough has been done to make a decision as far out as July 17th very unlikely.  Skipping ADCOM is huge.

I would be surprised if we did not have a decision by mid April or May. Call me optimistic.

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I have called you that for quite some time, Ed!
And I'd like to call you Mr. Underestimation.

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

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I like the sound of that!

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HSCT patients have worse CV19 outcomes

https://www.thelancet.com/journals/lanh … 4/fulltext

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

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These authors (Eleni is a sometime consultant for Omeros but declares no conflict and Omeros did not pay for the paper) is apparently saying CAR-T(adoptive cell therapy) cancer therapy can induce EIS and narso can fix it. CAR-T patients sometimes die from the treatment. Have we just been told WHY and that Narso can theoretically treat it ?
==========================
"In conclusion, novel cellular therapies have introduced a new era of endothelial injury syndromes. CRS and neurotoxicity present with a different phenotype but share many similarities with the endothelial injury syndromes post HCT (TA-TMA, GVHD or SOS/VOD). The interplay between complement, endothelial dysfunction, hypercoagulability, and inflammation emerges as a common denominator in these syndromes.

Similarly, recent lines of evidence suggest that endothelial dysfunction, hypercoagulability, and inflammation are also key players in the pathophysiology of CAR-T cell toxicity. Since complement inhibition has shown safety and efficacy in patients with endothelial dysfunction syndromes (such as TA-TMA), as well as in patients with excessive inflammation (such as severe COVID-19), it can by hypothesized that complement inhibitors will show efficacy in these new patterns of toxicity"

For the paper (Omer supported)
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7312228/

A New Era in Endothelial Injury Syndromes: Toxicity of CAR-T Cells and the Role of Immunity
Eleni Gavriilaki,1,* Ioanna Sakellari,1 Maria Gavriilaki,2 and Achilles Anagnostopoulos1

This article has been cited by other articles in PMC.

Abstract
Immunotherapy with chimeric antigen receptor T (CAR-T cells) has been recently approved for patients with relapsed/refractory B-lymphoproliferative neoplasms. Along with great efficacy in patients with poor prognosis, CAR-T cells have been also linked with novel toxicities in a significant portion of patients. Cytokine release syndrome (CRS) and neurotoxicity present with unique clinical phenotypes that have not been previously observed. Nevertheless, they share similar characteristics with endothelial injury syndromes developing post hematopoietic cell transplantation (HCT). Evolution in complement therapeutics has attracted renewed interest in these life-threatening syndromes, primarily concerning transplant-associated thrombotic microangiopathy (TA-TMA). The immune system emerges as a key player not only mediating cytokine responses but potentially contributing to endothelial injury in CAR-T cell toxicity. The interplay between complement, endothelial dysfunction, hypercoagulability, and inflammation seems to be a common denominator in these syndromes. As the indications for CAR-T cells and patient populations expand, there in an unmet clinical need of better understanding of the pathophysiology of CAR-T cell toxicity. Therefore, this review aims to provide state-of-the-art knowledge on cellular therapies in clinical practice (indications and toxicities), endothelial injury syndromes and immunity, as well as potential therapeutic targets.

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

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Dr. Eleni on narso in TA-TMA
https://twitter.com/VJHemOnc/status/135 … 97635?s=19
https://pbs.twimg.com/card_img/1358800407141703681/mcbpdOqC?format=jpg&name=small

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

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Here's Joe Baffoe's tweet right after the video - Joseph M. Baffoe
@_joebaffoe
·
2h
Replying to
@VJHemOnc

@elenicelli
and 2 others
Everyday the FDA waits to approve #Narsoplimab for TMA is another day a patient dies without access to the Drug. @US_FDA
do the right thing and approve Narso now.

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Joe has been pumping with all his might, even on STwits. I have considered suggesting privately that he tones it down a bit.

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

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As a point of interest, do you think he could be in financial difficulty, such that he is desperate for a big winner, soon, in Omeros?  I have read in several books over the years that this type of behavior and vocalization could be a manifestation of financial difficulty.  Not a definite, but a possibility.

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Maybe, if he lost his job as CEO.

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

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A good primer on the endothelium
*******************
MYELOMA NEWS
By Paul Kleutghen | Posted - Jan 28th, 2021

TMA, a Rare Complication of Stem Cell Transplants
The title of this post is somewhat misleading in that the word ‘complication’ may conjure up a host of reasons why not to consider stem cell transplants (SCT). To the contrary. This post actually will turn out to be GOOD news.

First, what is TMA? TMA is shorthand for thrombotic microangiopathy (more in a bit). In specific, this post is about stem cell transplant related TMA (HSCT-TMA). The treatment regimens that we are familiar with (conditioning regimen prior to transplant, toxicities associated with immune-suppressive drugs as well as infections that may occur during our treatment), may cause injury to endothelial cells. Graft-versus-Host-Disease (GvHD) in allo stem cell transplants is also a leading cause for TMA. The endothelium is a single, fragile, layer of cells that line all the blood and lymph fluid carrying vessels in the body, including the chambers of the heart as well as the ‘filters’ in your kidneys. You may not know that it exists,  but it plays a vital role in keeping you alive. An average person has about 1 kg (2.2 lbs.) of endothelium and its total surface inside the body is estimated to be between 4,000 to  7,000 square meters (or 40,000 to 70,000 square feet – approximately  1 to 1.5 acres).

And what does the endothelium do?

Monitors and controls the release of water and electrolytes in the blood
Controls blood pressure by relaxing and contracting blood vessels, in response to hormonal or other signals
Prevents blood from clotting inside the blood vessels by releasing anti-clotting factors when needed
It keeps things OUT of blood vessels that shouldn’t be there and keeps things INSIDE blood vessels that shouldn’t be elsewhere
Grows and repairs blood vessels
It does not take much imagination to start thinking of a number of health problems that may result from injury to the endothelium or to endothelial cells from our treatment for cancer. Transplant associated TMA is increasingly identified as a complication seen in both auto and allo stem cell transplants. If not promptly diagnosed and treated, it can lead to significant long-term organ damage. Thrombotic microangiopathy means that tiny blood clots have formed inside the smaller/smallest blood vessels and often manifests itself as kidney damage and kidney failure. There has been no approved treatment, to date, for the treatment of HSCT-TMA.

The good news for today, though, is that the US Food and Drug Administration has accepted the regulatory submission for the compound narsoplimab a few days ago. The Agency had labeled this drug with its rare ‘Breakthrough Therapy Designation’ and has granted its developer (Omeros Corporation) Priority Review. For all practical purposes, this means that we may say this drug come to market and into clinical practice as early as July 2021. Patients that have been treated with this drug, in accordance with the study protocol, during its clinical investigation showed a 65 % complete response rate.

This medical milestone is summarized in the Company’s press release:

‘Endothelial damage, which activates the lectin pathway of complement, plays a central role in the development of HSCT-TMA. The condition occurs in both autologous and allogeneic transplants but is more common in the allogeneic population. In the United States and Europe, approximately 25,000 to 30,000 allogeneic transplants are performed annually. Recent reports in both adult and pediatric allogeneic stem cell transplant populations have found an approximately 40-percent incidence of HSCT-TMA, and high-risk features may be present in up to 80 percent of these patients. In severe cases of HSCT-TMA, mortality can exceed 90 percent and, even in those who survive, long-term renal sequalae (e.g., dialysis) are common.’



This news may not be of value to all of us, myeloma patients, but is certainly a welcome development for those of us who will be walking the road of allo stem cell transplants.

Find more myeloma news and information on www.myelomacrowd.org

Paul Kleutghen
ABOUT THE AUTHOR
Paul Kleutghen - I am a patient diagnosed in 2014 with primary plasma cell leukemia (pPCL), a rare and aggressive variant of multiple myeloma and have been very fortunate to find treatment at the division of Cellular Therapy at the Duke University Cancer Institute. My wife, Vicki, and I have two adult children and a grandson who is the ‘light of my life’. Successful treatment has allowed Vicki and I to do what we love best : traveling the world, albeit it with some extra precautions to keep infections away. My career in the pharmaceutical industry has given me insights that I am currently putting to use as an advocate to lower drug pricing, especially prices for anti-cancer drugs and, very specifically, CAR-T therapies, with recent contributions posted by Health affairs, the Institute for Clinical and Economic Review and the Centers for Medicare and Medicaid Services.

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

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https://charts.stocktwits.com/production/original_286514270.jpg

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

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Seems like a chicken and egg problem

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Solved by the egg for breakfast and the chicken for dinner, I hope.

I think there are Omeros shorts handing on, who are like amateur longs. They have had to change their thesis, now that a belief that Omeros is a scam is just as stupid as Trump never lying.

My guess is the shorts are hoping that the whole market tanks and saves their ass because it takes Omeros down with it (which is likely but not sure, depending on the news).

With the FED printing and supporting the $1.9T in added spending by the Biden Admin how will the market really crash?

Famous Last Words?
I hope not.

The more pumping the higher it has gone...even if the price is weaker US$ and slowly rising interest rates, which can be fixed by the FED whenever it wants.

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

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One of the email group points out some evidence endothelial injury could be a/the cause of Alzheimers

So do we think this will be an indication Narso will be able to treat?  It looks like endothelial damage plays a significant role.

They are already talking about:traumatic brain injury, ischemia-reperfusion injury,
in the last 10Q

https://pubmed.ncbi.nlm.nih.gov/24251393/

Alzheimer's disease (AD) is characterized by a progressive decline of cognitive functions and represents the most common form of dementia and a major cause of morbidity and mortality in the modern, westernized societies. There is accumulating evidence to support the hypothesis that a primary cerebral vascular dysfunction initiates a cascade of events that lead to neuronal injury in Alzheimer's dementia. The endothelium, in specific, constitutes a part of the blood brain barrier, the dysfunction of which is thought to play an important role to disturbed amyloid-β homeostasis and infiltration of the brain parenchyma with circulating toxic molecules in the disease. Furthermore, the endothelium itself is under certain conditions capable of producing neurotoxic and inflammatory factors, whereas common growth factors regulate the development and maintenance of both neurons and blood vessels. Reliance of both endothelial and neuronal cells on mitochondrial integrity and common molecular pathways for apoptosis also imply that there is a link between vascular pathology and neurodegeneration. The present article intends to review available evidence on molecular players implicated in the above mechanisms with the potential to develop biomarkers or novel therapeutic targets.

Somehow Greg has found a key to the lock that nobody really knew about or paid attention to. EIS could be causing heart attacks, kidney failure, strokes, blindness, and a variety of other syndromes thought to be separate from other things, like Alzheimers (which has not been even close to cured, or even stopped (much less reversed) by following the recent theories of what causes it)

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

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And by owning the key, he has removed some of the incentive for others to look for the lock.

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I am not sure I understand your analogy, Jim. There seems to be companies pursuing the same old theories about the causes of Alzh (plaque buildup) even though there is good data (IMO) is it NOT plaque, or at least not plaque alone. There are data from a large number of old people followed for a long time before death, given mental tests to detect deficits and progression over time. When these people, who had agreed to have their brains studied after death, died, the examined their brains and the amount of plaque had no correlation with the decline in mental abilities. Some people with lots of plaque were normal and some have varying level of lost mention ability in short and long-term memory and everything that affects (like naming things, places, people, loss of sense of direction and location, etc.).

If plaque plays a role it is only when something else turns it into a problem.

EIS perhaps.
Or it could be EIS alone or with a variety of other causes.

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

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Yes, fully agree that Greg is uncovering relationships with huge potential therapeutic and business value.  I was being a bit tongue in cheek, but the basic premise was that Omer control of the Lectin pathway in general and for EIS, may lead to some researchers or companies to not focus research in that direction.  The NIH paper you reference certainly is not an example of avoidance, but there may be other that look elsewhere if all roads lead through Omer (roads would lead through Omer if Lectin pathway is the key).

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I see, so you were alluding subtly to something like ALXN's support of some of the researcher who's research was illustrating how the Lectin pathway is more crucial for safety and efficacy than the drugs of the competitors, including ALXN.

Greg not only recognized that INFLAMMATION is blamed for many illnesses/conditions/symptoms and auto-immune diseases and problems seem to be more and more common... and causing inflammation..but there is only something to treat the end-effect of inflammation.

IOW, treatment damps down the inflammation, usually with steroids or NSAIDs.

Greg recognized the work on the Lectin Pathway as what was the earlier link in the chain... the part of the immune system that caused the inflammation.

So narso inhibiting the inflammation starting, or reversing it eliminates the need for steroids (which have very significant negative effects, especially with chronic use).

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

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Add another one:

Endothelial dysfunction, cardiovascular disease/premature cadiovascular aging, and Covid-19

This is a general report, not Narsoplimab-specific, presentation on endothelial injury.

Looking forward for Narsoplimab to prevent premature aging.... If only it would treat non-premature aging.

video
https://www.youtube.com/watch?app=deskt … Lq-ece2fS0

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

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Note that Dr. Perales is the top rated KOL in the list near the bottom of this post.

https://charts.stocktwits.com/production/original_289392476.png


#TCTM21 Conference Hashtag
Transplant and Cellular Therapy Meetings of ASTCT and CIBMTR
Mon 8th Feb 2021 - Fri 12th Feb 2021
The TCT | Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR (TCT Meetings) are the combined annual meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR).
Conference Website

#TCTM21 is a conference hashtag

What is #TCTM21?
Healthcare Topics
Cancer
Hematology
hematologic malignancies
stem cell transplant
Related Hashtags
The influencers of #TCTM21
    ASTCT @ASTCT    100
    Miguel Perales M.D. @DrMiguelPerales    100
    Navneet Majhail, MD, MS @BldCancerDoc    97
    CIBMTR @CIBMTR    92
    Akshay Sharma MD @AkshaySharmaMD    91
    Uroosa Ibrahim @uroosaibrahim    91
    Hemalatha Rangarajan MD @hmgcoa2    89
    Krishna Komanduri, MD, FASTCT @drkomanduri    75
    Samer Al Hadidi, MD MSc @HadidiSamer    73
    Tania Jain @TaniaJain11

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

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It is usually a struggle to get MDs to change how they treat patients. They are very conservative. Pharma sales people personally visit MDs all over the world to encourage prescriptions... but Covid has disrupted this.

It is unlikely to hurt narso for TA-TMA very much since there are few transplant centers, but it won't help.

A short article about using Tech-enhanced marketing can be found here:
http://www.trustintelligence.com/viewto … 3253#p3253

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

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A week ago OMER got a new patent that reveals something that is VERY interesting and that, I would have thought, would have led to a press release.

To get the patent approved they showed data that proves that the way the complement system is thought to work IS WRONG.

THEY will have to rewrite the medical textbooks on complement and give Greg and Schwaeble credit for discovering that the Alternative Pathway is NOT an independent pathway. It is controlled by the pathway controlled by

OMEROS

and we know that is the LECTIN PATHWAY.

New patent from Feb 11, 2021.

https://patents.justia.com/patent/20210040229

The present invention is based upon the surprising discovery by the present inventors that MASP-2 is needed to initiate alternative complement pathway activation. Through the use of a knockout mouse model of MASP-2−/−, the present inventors have shown that it is possible to inhibit alternative complement pathway activation via the lectin mediated MASP-2 pathway while leaving the classical pathway intact, thus establishing the lectin-dependent MASP-2 activation as a requirement for alternative complement activation in absence of the classical pathway." "These results provide strong evidence that the alternative pathway is not an independent, stand-alone pathway of complement activation as described in essentially all current medical textbooks and recent review articles on complement." "In other words, the alternative pathway is a feedforward amplification loop dependent upon the lectin and classical complement pathways for activation, rather than an independent linear cascade."

Those who have a drug that affects the Alternative Pathway will have to face competition from drugs that can turn it off by using Narsoplimab or its successors.

People who really know the complement system find this very bullish. I still have lots to learn before I try to explain it to you (I'd be happier if you would explain all the advantages this gives Omeros... to me).

Bill? Ed? Jim?

So, it also tells me that when we were thinking that narso treatment was turning off the LP, it was also turning down/off the AP.

Makes me wonder if there are situations you want the AP on and the LP off.

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

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From everything I have gathered so far, the real trouble would be interfering with the classical pathway and suppressing the body's natural immune response.

As interesting as that filing is, Omeros is still pursuing alternative pathway inhibition separately with MASP3 inhibitor OMS906.  Which makes me believe they feel it is a better approach, perhaps a more defined approach than what Narso could do in complement inhibition of the alternative pathway tied to the action in the lectin? Above my pay grade I'm afraid.

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My technical understanding of the complement system and "pathway stuff" is way too shallow to provide any meaningful comments.

I'm basically just spectating in that area.

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Yes, I think that is a valid question.  I assume that the LP and AP don't both exist in nature for the exact same reason.

90

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And we are wondering what takes so long?  Someone inside Omeros wrote that, right?  And what is more interesting to me, someone at FDA actually understood all of it?  If so, I wonder what their salary is, compared to what they might make inside the industry, instead of in Government.  Just curious about that.....I'm like Bill, no understanding of the bio-chemistry, but still, it sounds like an important patent to me.

91

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Maybe for hard cases they prescribe 721+906=#1627

Doubly inhibit the AP.

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

92

Re: Narsoplimab generally

Some turkey just ask people on ST whether the FDA "could" approve narso before the PDUFA date.

Isn't this a silly question?
The questioner admits he doesn't know the data (yes, FDA has been know to approve drugs with Priority Review in less than 6 months) but his thinking is fluffy, indistinct, inexact, naïve.

Almost anything COULD happen. The FDA could approve Narso tomorrow. But is it likely? (NO)

I thought it worthwhile to use the question to remind everyone that I have seen approval as fast as after 2 months for a new indication of an already approved product, and 3 months for a new drug.

That said, I do not monitor all FDA approval decisions (with or without Priority review) so I cannot handicap the probability OMER will get an approval in less than 6 months. I have reasons why I think it is very possible, but that relies on logic, not really on hard data.

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

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Yes, that person used some poor language.  Greg made a statement at one point that he expected revenues during the 2nd Q, or something to that effect.  Certainly can't take that to the bank though. 

I think it's a  discussion best left to have after the earnings release and call presumably next week or perhaps the week after.

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Only the language.
It is not unknown on a message board for people to predict the future definitively.

Others ask people who presumably know more than they do, to tell them what is going to happen, when the persons being asked cannot know the answer and has no good way to estimate the probability.

A basic skill is to know when you don't know.
Another is to know when someone else telling you something definitive cannot know what they are telling you.

It is the old BS detector thing.
How can you  be a successful investor without asking how a source can know what they are saying is correct?

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

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Re: Narsoplimab generally

Best Practices in the Diagnosis of HSCT-TMA

Faculty: Edwin P. Alyea, MD (Chair) Christopher C. Dvorak, MD Vincent T. Ho, MD Miguel-Angel Perales, MD

https://cdn.fs.pathlms.com/5Q2B3TAkSs2R … cache=true

IMPLICATIONS FOR CURRENT AND EMERGING TREATMENTS

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

96 (edited by dorcse 2021-02-26 09:23:26)

Re: Narsoplimab generally

Thanks Alan.  I've looked at one drug mentioned there multiple times, Defibrotide.  Derived from pig guts (no kidding), this treatment has shown some efficacy.

Of note is a Phase 2 Defibrotide TMA Prophylaxis Pilot Trial

"The feasibility, safety, and efficacy of defibrotide prophylaxis in a pediatric transplant population is unknown. Twenty five patients age 0 to 30 years receiving autologous or allogeneic hematopoeitic stem cell transplant who meet TMA high risk criteria will be enrolled. Patients will receive Defibrotide for 28-35 days starting before conditioning, and will be closely monitored for any adverse events up through 6 months post-transplant. The feasibility of administering defibrotide will be evaluated as well as incidence of TMA."

Two things. 


1.  They concentrate on pediatric transplant population only (0-30 yrs.) I believe this is a group proven to do better with TMA and easier to treat. 

2.  The long conditioning regimen of a month or more pre-transplant looks cumbersome and probably not preferred given all the pre-transplant drug regimens patients are already subjected to (in my opinion anyway.)

https://clinicaltrials.gov/ct2/show/NCT03384693

97

Re: Narsoplimab generally

Is it possible to evaluate, or compare, the efficacy of Narsoplimab vs the other drugs used, from this article?

98

Re: Narsoplimab generally

What specifically, Avi.

A drug in a trial has no real results.
We have not seen data on narso in a pediatric population, but it should not be much different and narso is the only complement intervention that doesn't ruin a person's immunity... which in this case is already super low because their marrow has been purposely killed.

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

99

Re: Narsoplimab generally

That article was from May 1, 2020 ...... containing info we've seen for some time.

100

Re: Narsoplimab generally

IMO The REALITY is that nobody is going to get an approval of a TMA drug before Omeros.

And nobody has a safer drug to stop and reverse and prevent TMA, as far as we know.

And Nobody has a TMA (or any other focused) drug that affects the Lectin Pathway (LP).

So this gives Narso time to take the HSCT-TMA market.

If there is not many people needing the drug, the price can be higher as long as narso is not approved for anything else.
When it is approved for something else, I presume that revenue will soar even if the price per ml will be reduced if necessary.

There is no competition breathing on narso's  neck.

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