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I cannot comment on that with any knowledge or authority.
Years back when I was in a Gilead trial I was curious where the drug batches came from for trials. I'm in Iowa, and as it happened it seemed that one location may have been my hometown.
I think there may be a difference between the early trials and small batches and the large scale final formulations. Recall that in NASH Enanta shifted I think from a liquid to pill form which changed the bio-availability.
I think both Enanta and Pardes maintained they had adequate funding (and I think adequate supply) until such a time as large amounts of drug (and I'd suppose some registered/validated process of mass production) was required. I'm absolutely out of my depth here. : )
I also wonder if the EUA amount of drug required, let's say for a phase 2 is less than a standard amount for a full blown standard phase 2. It seemed to me that in vaccines one of the criticisms was that the FDA was proceeding with scant data -based upon trial participant cohort size.
Finally, the trial I was in I was in a 24 week once a day 200mg dose. (if I correctly recall)
In the case of Enanta it could be once a day between 100 to 500mg for 5 days. That's a large difference in quantity required.
What takes a lot of time is generating enough API for high-volume output. Producing small amounts of the drug for early-stage clinical trials is not a problem.
[OT]—Registering for Twitter is free. Moreover, I never see any ads (a/k/a promoted tweets), and this can't be due to my having an browser-based ad-blocker (which wouldn't be able to recognize promoted tweets as ads). I access Twitter using the website; maybe things are different for those who access Twitter via mobile platforms.
I don't know, but possibly.... just as paywalls have become more stringent I think twitter has tightened up content provided as a means to lever the unregistered.
I used to be able to view months, perhaps years.
Over time, but today particularly by clicking on your link a few posts back I could view 3 tweets of yours.
By clicking on your profile I am able to view 4 (the Pharmasett tweet being one)
By viewing $ENTA daily I am likely able to read yours as they arrive.
I suppose I should register or pay. Probably true also-subscribe to Ihub. : )
I didn't realize there were restrictions on what a non-subscriber could read.
Yes. I read as much as I'm allowed to as an unregistered twitter lurker. I suppose I should register/join. I think in the past I could view more. It's a great resource. : )
Good points. Did you read the other tweets in the thread I linked to?
The article was primarily about Pardes which doesn't look that promising to me -albeit possibly better than Pfizer. In a recent pitch they mentioned that they were going to have to run more phase 1 in the USA, and the once a day dosing without boosting seemed a bit more tentative.
Further, a follow on compound so close to their lead covid program seems to suggest a rushed entry.
The very last line in the article stated the Pardes compound *could* be approved at the very earliest by year end. That seemed like a stretch.
Shionogi seems far more promising. (I've seen no response data tho)
The covid landscape keeps changing. There always seems to be a new resistant variant to vaccines. The seriousness of covid to the unvaxxed remains, and may take a while before it visits both the unvaxxed and the less protected or immunocompromised/ aged/ groups plagued by other co-morbidities and diminishing vaccine protection. (4th shot boosters not very effective?)
On the other hand the focus on the main players in antivirals will become more clear - as will the treatment tail of covid. Will it become like the swine flu and depart, or will it become something more like a continual almost endemic- leaving far more slowly than we first expected?
Much like early HCV programs, the initial players success may be short lived. Pfizer's Paxlovid seems the main player. The Merck compound molnupiravir seems far less important.
The Pardes covid presentations might be better than their lead compound. : )
Jay Luly exercised and held $600K of stock on 1/15/21:
https://www.sec.gov/Archives/edgar/data/0001177648/000106299322001104/xslF345X03/form4.xml
Exercising and holding—paying the withholding tax with cash rather than forfeited shares—is mathematically equivalent to an open-mkt purchase.
Even IF it was so that the Leerink price of $80.00 is correct....
we are still 20 dollars under that.
I feel as though once the covid molecule EDP-325 moves along and is de-risked the share price will move.
If ONLY the covid program is good- just that one thing will surely move us upward- well beyond $80.00/share.
Willow,
We are on the same wavelength as I bought more yesterday and bought again today.
Enanta is thinly traded. So it doesn't take much trading to move the needle.
There was ONE downgrade of 5 dollars and it fell over $10 in two days. A downgrade might do that. A retiring board member selling shares adds fuel and velocity to the selling..... triggering yet more selling.
What will the stock trade at when they start covid clinic work in a few weeks?
When they post (and if) positive RSV data soon?
When (and if) they start covid phase 2/3 in second half of year?
I bought more today.
Why the plunge today on a $5 price target drop?
Correct—the "second" MoA is an off-patent nuc.
The main differences between the 1/11/22 slide set and the previous (11/18/21) slide set are in slide #15 (EDP-323 info) and #30 (2022 news flow).
Shionogi—(SGIOY)—is a Japanese Big Pharma—certainly not under-the-radar. I mentioned Shionogi’s COVID program in #msg-167153263; the program is in phase-2/3 in Asia, but hasn’t yet started in the US.
As you know I bought a small amount of Pardes (at this moment green)- not so much as a hedge, but as a sort of surrogate real time notification system, and to force myself to pay more attention to the competition.
One could do the same with other covid compounds being developed.
When I look at Enanta's slide 20 (2022) I see another competitor with a PI. They are in phase 2/3 and project once a day dosing.
It is even more thinly traded than ENTA and in spite of possibly being a contender their stock has been flat- perhaps the opposite of AVIR in a few ways. SGIOY (?). It seems wholly off the radar. All things being the same- approval before Pardes.
If PFE will have the major covid antiviral- whose will unseat PFE's?
Any thoughts?
One unknown in this, which I expect that no one knows the answers, are two factors (perhaps this would be better as a separate post)
1) The trajectory of covid which could mutate into another delta like scenario which escapes vaccines OR conversely promptly winds down to endemic
2) The path of EUA (Emergency Use Authorization) and it's effects upon drugs in development. The outcomes for drugs being developed could change radically (along with their stock price) contingent upon -for example purposes only- if the EUA extended into next year versus if it ended next month.
I'm forced to imagine how the EUA will impact drugs in development- both in best and worst case scenarios.
The difference is timing is so small I consider it insignificant.
It was ALGS' lead HBV candidate, which is why the stock was down >50% yesterday.
This is yesterday's ALGS PR:
https://finance.yahoo.com/news/aligos-halting-further-development-stops-130000126.html
*Correction* “Hep B asset”
(ENTA)-ALGS drops Hep B program.
from: @OxAnalyst on Twitter
$ALGS dropping STOPS hep B asset* due to lack of efficacy (no meaningful HBsAg reduction)
— . (@CrocsAnalyst) January 6, 2022
one of two clinical candidates in their pipeline pic.twitter.com/IqC5poNCwM
ENTA 2022 newsflow:
https://www.enanta.com/investors/news-releases/press-release/2022/Enanta-Pharmaceuticals-to-Provide-Updates-on-its-Research-and-Development-Programs-and-Outlook-for-2022-at-the-40th-Annual-J.P.-Morgan-Healthcare-Conference/default.aspx
• EDP-235 phase-1 starting Feb 2022. (EDP-235 is a SARS-CoV-2 protease inhibitor.)
• Phase-2 ‘RSVP’ data for EDP-938 in 2Q22.
• EDP-323 (RSV L-protein inhibitor) phase-1 starting 2H22.
CEO, Jay Luly is a 6.5% shareholder:
https://www.sec.gov/Archives/edgar/data/0001177648/000119312521361165/d273825dsc13da.htm
I'd like to think that this is a bottom.
I've been waiting and today I bought a bit more.
It appears that I wasn't alone.
Anyway, the day ended with a hammer on good volume.
Covid isn't going away.
ENTA will benefit by PFE's success with their PI. IMHO
Protease inhibitors as a therapeutic treatment for covid will soon be validated. People will see patient success, prescription numbers/$$$ and realize that theraputics will help recovery and transition from pandemic to endemic.
I understand people not wanting to buy until EDP-235 enters clinic, but that could be in the near future and Luly has mentioned phase 2/3 in 2022.
I would think a partner in covid would bolster share price dramatically. Would it be reasonable to compare it to the AVIR/Roche collaboration?
It's an aside- but Luly has mentioned a few times that EDP-235 shows potency against other coronaviruses.
At some point if successful that may also have some non-covid value attributed and some follow on compounds.
Even by ENTA's standards, day-to-day and intra-day share-price volatility have been crazy high lately.
It's harder to add now than when ENTA was half this price- but I've added small amounts recently.
The days volume (w/ after hours added) was over 500K! I hadn't checked since the AM- not bad for a stock that could only muster 1300 shares the first 20 minutes. Talk about thinly traded. : )
ENTA presentations the next 2 days -Dec 1 and 2.
Not only does Molnupiravir improve outcomes for the covid infected- it even improves the placebo arm!!! : )
Thanks Dew. I've not heard that one. ~ It's awesome!
(AVIR take note!!)
Re: Observed fall-off in Molnupiravir efficacy
From #msg-166912284 (posted last week):
Something is better than nothing after all.
And there is money to be made by merely being first.
Remdesivir has probably sold over 2 billion now.
AVIR is up some more- about 5%. Hope springs eternal. : )
MRK's Molnupiravir is being evaluated by an FDA adcomm today:
AVIR’s COVID antiviral has already failed:
#msg-166797909
#msg-166425975
Investing in a thinly traded stock is confounding.
This morning Merck is down for a few reasons
Moderna is down due to concerns about vaccine effectiveness against the new variant.
Pfizer is up (IMHO) due to faith in it's vaccines (relatively) but perhaps more so due to faith in it's covid antiviral (a PI)
Who else is up? AVIR at 8.06 this moment up 3%+ presumably an on hopes of it's Covid antiviral will work 225K shares traded.
And then there's ENTA which sat forever at -1.44 cents and 5800 shares traded.
My take on it is people aren't buying or selling their ENTA.
They are holding for news, waiting for catalysts.
Due to the new variant no one really knows where to put their $$$.
I held.
Generally speaking I think we are seeing the strength of vaccines being tested and the importance of antivirals growing.
In general, Merck's antiviral has lost some credibility, AVIR's will probably be worse. Pfizer's looks best at the moment- one reason it is up- while Moderna is down.
(Enanta's covid antiviral - a PI- looks promising but no human data- and that's months away)
AS I was typing ENTA has RALLIED to -.51 (minus) cents and 82 hundred shares. and AVIR hit 4%+
So much of investing is merely waiting.
More on the same topic (ENTA's HBV program):
https://twitter.com/DewDiligence/status/1463579276842881034
ENTA’s fully-diluted share count @9/30/21=24.4M—an increase of 0.3M since 6/30/21 (#msg-165355921).
The 24.4M figure above consists of: 20.2M basic shares on the 9/30/21 balance sheet (https://www.sec.gov/ix?doc=/Archives/edgar/data/0001177648/000095017021004895/enta-20210930.htm page F-4 ); and 4.2M options outstanding at 9/30/21 (whether or not exercisable) (ibid, p.64).
ENTA’s pro forma cash @9/30/21=$391.3M—a decrease of $16.9M since 6/30/21 (#msg-165355929).
The $391.3M figure above consists of: $282.8M of net current assets on the 9/30/21 balance sheet (https://www.sec.gov/ix?doc=/Archives/edgar/data/0001177648/000095017021004895/enta-20210930.htm page F-4); and $108.4M of marketable securities on the 9/30/21 balance sheet designated as long-term (e.g. bonds with a time to maturity greater than one year).
Note: Among the current assets is a $37.3M tax-refund receivable from the IRS, pursuant to a provision of the 2020 Cares Act that permits businesses to carry losses backward to offset previously paid US federal income taxes. This provision of the Cares Act has now expired, so ENTA will have no future tax refunds of this nature.
ENTA did not give an estimated time for that.
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