Re: OMEROS (OMER) - Main Corporate Thread
The rolling aspect of the BLA should help reduce further processing time hopefully, although we don’t have benchmarks.
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The rolling aspect of the BLA should help reduce further processing time hopefully, although we don’t have benchmarks.
Should reduce the 2 month to acceptance to (maybe) 2 to 3 weeks at best (my guess).
Whether it affects the subsequent period, making it less than 6 months depends partly on whether they award Priority Review. Also may have something to do with FDA backlog, Holiday season vacations, and what files they want to close before 2021.
Acceptance in 2 to 3 weeks would be quite the coup for Greg. That would put a nice dent in the shorts arguments
I am presuming a few things.
1. everything submitted prior was already approved and made up at least half of the full submission, and it was fully reviewed in the long time the FDA had it.
2. The FDA normal "acceptance" scrutiny takes 2 months for a normal Phase 3 trial so that means they doubled the time it actually took to perform their task to make sure that they could consistently complete even the largest submissions within the 2 mmonths.
3. The average Phase 3 trial has 500 to even 1000s, of patients in multiple groups, with statistics and often years of data for each of the many patients. Omeros's trial had 28 patients for 100 days, only one group and that means there is actually less work.
4. The FDA has accepted other BLAs in less than two months and, I recall, as short as a 3 weeks to a month.
So, logic and a few logistical considerations tell me that they would not need 2 months if it was a regular, not rolling, BLA, so with less that half of a small BLA left, it should take the FDA less than half the time... unless they purposely sit on it to deliver in 2 months.
That could bring us good news before Christmas Day.
We deserve it.
And so does Omeros, IMO.
Omeros (NASDAQ:OMER) Given “Buy” Rating at HC Wainwright
Posted by Joseph Griffin on Nov 24th, 2020
HC Wainwright reaffirmed their buy rating on shares of Omeros (NASDAQ:OMER) in a research note released on Monday morning, AnalystRatings.com reports. HC Wainwright currently has a $32.00 price objective on the biopharmaceutical company’s stock.
Things could line up for a very nice tailwind into Spring, although with the short interest still 12+ millions shares I expect that those shorts will look to manufacture an opportunity to cover. Assuming Omer doesn't do another large financing, I don't see what information they could "know" which would enable them to cover without a large increase in price.
HC Wainwright certainly is consistent and unwavering. I still have one of their detailed reports from 2017/2018 I believe. I'm pretty sure it had a $32 price target or something close to that.
The analyst (Raghuram Selvaraju, Ph.D.) was a clock repairman and figures sooner or later his prediction will be correct, since the watches he couldn't fix are still correct twice a day.
I have some of those same reports in my files.
I shouldn't make fun of him.
I have the Q1'2020 report he did, and then, his target was $34.
Apparently, given how little the market has reacted to OMER in CV19 or finishing the BLA submission, he's scaled back his assumption that the Market will "get it".
But only by $2.
The stock could be worth $50 compared to its peers but shareholders have suffered so continuously, The Man of LaMancha starts to play in the background when any of us think of a price that starts with a $2......
A fellow mentioned doing call spreads on the January 2022 contract of Omeros.
The highest strike price then is $25 (there are also January 2023 contracts available). He was buying the $15 and selling the $25 and this gave him a potential 350% move., as if the share price had gone from $12 to $42.
Of course, you lose the whole investment if the stock is $15+your net spread cost.
And if OMER gets approved for CV19 and the price goes over $25, you profit won't go up.
But your loss is limited to the net premium and over a year in duration gives OMER time to finally got significantly higher. If it is not enough time, there are those Jan. 2023.
Of course, the Market Maker will carve out a profit for herself, because the spreads are wide.
Market activity is low volume and pitifully weak, aka 'normal'.
Painful and boring to watch.
I suppose that most of the impatient and short-term traders and gone, although there has been so days when this pattern led to a recovery late in the day.
I think the "normal" you are talking about is the result of people simply waiting for the next step to happen. In my view, this stock has been just about as completely derisked (up to this point in the process of development) as it can be. But not for a second do I think the shorts are finished here.
Whether BoA and JPM end up as friendly warriors on our side remains to be seen.
This is a jpg file so I can't edit it. Most of it is Peter Lynch talking, except at the end, where it is the guy recommending you pay attention to Lynch and Buffet's buy and hold great company strategies.
Certainly is less work.
And I'd like to do it.
Keeping in mind that my friend Dave bought PCYC at about $1 and sold it over $3 but did not own it when it went over $260/shares....
Which is why I am posting this little story on the OMER thred.
There is another story from Lynch:
He said his wife invested $750 into her IRA from 1974 to 1978, and in total she put in $3,750. Obviously, he invested it for her.
Over the years she withdrew $3 million during her lifetime.
When his wife passed away in 2014, the account was worth $8 million.
In post 60, I pointed out that I kind of expected the rise at the end of the day in OMER.
I was tempted to buy more when it was down in anticipation of selling at the end of today, which I could have done, for a nice little profit, if I had the time. I have been doing last minute traveling preparations and had 2 orders in, so I passed on the opportunity, but I shouldn't have.
Volume zoomed at the end.
So, the MMs or shorts pushed the price lower all day and then accumulated all the shares on the way up, mostly in the last 15 minutes.
Either the MM is accumulating for a large buyer with a buy on close, EOD, order... or it is short covering, after having driven it lower.
We could get positive CMS news on Omidria this week. I seem to recall the 2021 rules are due out this week or in the last week of the month. Don't recall which.
Look at the buying that knocked it lower in the morning and how sustained volume sent it up in the last 15 minutes.
This doesn't happen every time, but it happens to Omeros relatively frequently.
Alan and Geri should drive between Boquette and their new villa more often .......
Something certainly seems to be up. Could be any number of things, but my guess would be Omidria related news
What happened? I just hooked up to the net.
How much can we collect from Omer shareholders for me to drive tomorrow?
I think the 2021 Rule may be released tomorrow, as Jim said. But as I wrote a few days ago, if not tomorrow, then at end of Dec.
There is Govt. deal news possible... maybe.
I'll buy you a coffee - on the other side of town!
Honestly - I think the real reason it jumped was because i closed out my out-of-the money december 12 options yesterday - so as soon as the market saw that, it realized the stock could go above 12.
"CMS released the annual Physician Fee Schedule (PFS) final rule about 20 min ago. Should have an update on OPPS and ASC 'very soon'"
I received 2 press releases from CMS today and neither were concerning PFS final rule. The ST person did not provide a link and I can't find anything on it.
My setup here is not fully functional & I am having trouble with the new keyboard ... plus all my CMS and Omeros news were set to come to email@example.com, which has not yet been set up at the new website host.
Zacks downgraded OMER a couple of weeks ago to sell. They do this by computer and their computer is an idiot.
Today they say they were right all along and then say to buy something else:
Omeros (OMER) in Focus: Stock Moves 8.5% Higher
Zacks Equity Research
Wed, December 2, 2020, 8:57 AM EST·2 min read
Omeros Corporation OMER was a big mover last session, as the company saw its shares rise nearly 9% on the day. The move came on solid volume too with far more shares changing hands than in a normal session. This continues the recent uptrend for the company—as the stock is now up 24.1% in the past one-month time frame.
The company has seen one positive estimate revision in the past month, while its Zacks Consensus Estimate for the current quarter has also moved higher in the same time frame, suggesting that more solid trading could be ahead for Omeros. So make sure to keep an eye on this stock going forward to see if this recent jump can turn into more strength down the road.
Omeros currently has a Zacks Rank #3 (Hold) while its Earnings ESP is 0.00%.
Omeros Corporation price | Omeros Corporation Quote
A better-ranked stock in the Medical – Products industry is Quidel Corporation QDEL, which currently carries a Zacks Rank #1 (Strong Buy).
I've been in regular contact with staff from Nonopioidchoices.org (Choices) regarding NOPAIN and participating in the monthly webinars as well as doing some outreach to house and senate members representing Massachusetts on their behalf.
From a recent email with Choices dscussing possible passage of NOPAIN this year by including it in the spending bill or stimulus. 'We are hoping it will be included. Need as big of a push as possible this week so thank you for your help! Thanks Ed - Kali'
They do seem increasingly optimistic, but certainly obvious it's not a done deal (or they don't want to project that.)
Good work, Ed!
Perhaps there will be more shareholders who write, call, email their Congressional representatives....
$16.52 in AH trading???
I just got back in...wash shopping for to stock the kitchen.... you sure you don't want me to stay away from the computer, tomorrow???????????
I will look for the news.,, or rumors
Omidria NOT in NOPAIN Omnibus Bill... or may be but not needed (now) because CMS relented and followed their own rules.
CMS gave separate payment
The people who tipped off by CMS made a fast fortune. I wonder how many were politicians or political appointees.
Does make you wonder...
Anyway, excellent news Alan!
I have to caution that we will hear that it is only temporary as CMS makes a new rule every year.... So NOPAIN inclusion will not hurt.
so not to be a pessimist, but any bets on how long the burst will last until the fade? 3 hours? 4 hours? how fast can the shorts marshal their troops?
The Omidria development requires updates from all analysts given that none of the were confident this would happen.
It is an excuse to upgrade for the ones who are already positive. And may trigger an initiation of coverage from JPM.
Is this be end of the beginning or the beginning of the end?
True Alan. They will say separate payment is temporary because it is a yearly rule.
However, I would say to them look at Exparel, a non-opioid anesthetic that got a CMS exception to being bundled as a supply and successfully gained separate payment. As far as I know it has been granted separate payment every year since.
Agree NOPAIN would be a nice benefit.
You're so reasonable, Ed, for a guy who is as strong a long as I've ever seen (other than Greg1).
Are there any examples of drugs that were granted separate payment, which was then taken away? If none or few, perhaps that point could help thwart the shorts. Although I suppose they have no interest in truth or logic, their only interest being in Trump-like fantasies of crowd control, to their financial benefit. The thing is, it's not the shorts so much, but the weak-minded people who believe them or are scared to stand tall on their own.
A lack of precedent will not deter shorts from suggesting that.
This is actually quite poor from BAM, IMO
I have not seen anything but this.
CMS issued a final rule providing separate payment for Omidria for calendar 2021. We think the decision solidifies Omidria's potential as a continued source of funding for high-potential R&D programs. We forecast Omidria sales of
in 2020 with a peak of
Maintains Buy~$21 PT
Seems like they are saying that narso has zero value
I don't read that level of detail, at all... except that they do not address market cap as a sum of the parts, at all. We can say that, if they think it should be $21 then that is $1.25B market cap. I 2026 Omidria only has $100 million revenue, it is probably not worth more than $400 million today. So everything else is logically worth the remainder... but they did not say it.
The analyst report has as much to do with BAC policy as about Omeros.
I do read that that have a foolish revenue estimate for 2026. The written off $8Million from Q3 will be recaptured in Q4, and revenue should pick up in the remainder of this month, although revenue in October were small and I presume that will be the case for Nov.
Next year CMS will have new political masters.
Yes, I'm referring to sum of parts, especially with omidria revenue of $80 this year and growing over 5 years, albeit slowly. It seems to be that such a revenue stream could be valued at more than $400 million based on pharma comps, but I'd guess there are various comps one could chose to make whatever story they like.
My guess is that they do not want to express a target price (and underlying fundamentals) until they think the Market will support it.
IOW, the stock needs to hold gains, for a change.
We know why it doesn't tend to do that, of course.
And we have no effect on it except to the extent we buy and hold shares without trading.
Well perhaps the late day buying this week, and especially on Tuesday, was from shorts, and not longs, and that the shorts were looking to reshort 2 to 3 dollars higher, just enough to mute an advance.
I think pass-through is one piece of the puzzle. Hopefully NOPAIN is another, BLA acceptance, AA, approval, and narso sales are pieces 2 through 5, and some good CV19 news and then IgAN results will be overwhelming.
It seems to me that between the recent secondary and omidria sales, OMER will have the money to be much more aggressive, and I'd like to see them be ready ahead of time to amp up their PR campaign once they get narso over the goal line.
I wrote about the price being pushed lower and then volume increased in the last 15 to 30 minutes. Could have been short covering. And going long.
The shorts may have a CMS source, for all we know, and could have known early. Some think there is a source in Omeros. Nobody knows for sure.
Experienced shareholders either trade or they are patient. It is still aggravating when I think of hown many dollars in share price we lost over and over, each time there was bad Omidria CMS news or the anticipation of it.
We are priced as if there is NO pipeline.
We should perhaps spin it off and sell the stub with Omidria & the name OMEROS (but Greg would not want to do that).
One way to hurt the shorts would be to sell Omidria for say $500 million, if they could do that, and then announce a $x/share special dividend on say a Saturday with half the money after narso is approved if the price doesn't climb substantially.
There are a variety of ways to make the shorts' life difficult, but if you do it, and they decide to commit unlimited funds to hurt the company, you need BIGGER money as an ally.
It should be mentioned that we need to recall that Omeros did a share offering at $14.50 not too long ago and investors who bought have been underwater ever since.
They are natural sellers at $14.50 plus and maybe just under their purchase price. If the shorts bought a lot of the shares to cover, they effectively had sold them earlier at a higher price that was trashed by the reveal that OMER was issuing more shares.
Volume is over 4 million today. It was 1.2 million yesterday and 2.33 million on Monday.
This is all fishy.
I emailed Greg yesterday after the close, describing why I think there was a leak of the CMS information and it could have been to the shorts. I wrote about the things I wrote on TIPS with the daily take-down and late session high volume buying, and the abnormally high volume for 2 days prior to the official CMS announcement.
I did not expect anything in return.
Not long after, he called me (I travel with my Magic Jack US phone number), apparently for more than 1 related reason. He assured me that the leak was not from Omeros, indicating that the information came to HIM, not others, and he only found out at the last minute. I said I expected it was someone on CMS or HHS and he mentioned that would be a serious breach with very negative consequences. I replied that people do illegal things with serious negative consequences every day.
I also suggested that the Shorts were buying once they knew about CMS, making money on the rise and then to use the long shares to attack the price by selling them and shorting the rise.
We talked about the lame analyst reports (except perhaps the Maxim one, below, that raised the price target). And that the shorts have huge profits tormenting Omeros they can deploy to hurt us, so that we need a counter-force.
There were a number of talk-less pauses in the conversation. After 2 or 3, I had to ask..."are you still there?" and he said he was thinking.
A number of times in the discussion, he said some variation on "we'll see". While I am certain I am reading something into that phrase that is related to my own view/hopes, my impression was that he was saying "that's not all we've got to throw at the shorts...there is more good news coming."
That was my honest impression.
Not something you take to the bank.
I did not press for details about things he cannot divulge.
Perhaps this Maxim price target increase is reducing or eliminating the pullback (hopefully more than just for today). How can analysts see the return of full reimbursement of about $100 million in 2021 and NOT say that makes the company worth more?
Omeros price target raised to $25 from $20 at Maxim Maxim analyst Jason McCarthy raised the firm's price target on Omeros to $25 from $20 and keeps a Buy rating on the shares. The analyst is citing the recent CMS guidelines, which confirm that Omidria will qualify for separate payment under the ambulatory surgical center payment system as a non-opioid pain management drug. McCarthy adds that this decision marks a significant event for Omeros, as Omidria is the cash engine for the company.
Big addition to the prior post, in case you read the short version.