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@MS You didn't ask me but...
My degree says 'doctor' - not MD. But in medicine. If I say too much I can get kicked off the trials I'm currently helping with. I already had to sign a document stating I didn't own more than $__,___ of A____ ____ stock (which I do not) or I'd have been forced off that study too.
To your question, is there enough evidence in the Topline data for Ifenprodil for Covid-19? Well, there was going to be. For the one & only result that showed p </= 0.05, which was Time in ICU, Algernon wrote a poison pill into their own result by cautioning 'confounding variable found'. As I speed-read the Topline, all the references to 'needed to sufficiently power' made my Greed/Fear meter slam over to Fear. Then I spotted the p=0.0315 (Yay!!), then they crushed my flickering hopes.
When AGN states the numbers of participants needed in a Phase 3 to find Significance, it's running the math backwards from the 50/50/50 arm participants and the p-value found so far to come up with enough MORE participants at similar data trends to find p less than 5% or 1-out-of-20 odds that the findings are the result of random chance. This is the commonly accepted standard (for good reason) of statistical significance in FDA drug trials.
You can bitch & moan if you like but it's similar to the hot Tech company quoting non-GAAP earnings while big banks continue to downgrade the firm for showing a loss using GAAP accounting. You're not going to change the FDA's (or the big bank's) mind on what standard to use. Whining so just makes AGN apologists look like the Denial-inflicted bagholders on message boards for RLFTF, HGEN, and especially CYDY. We gambled, we crapped out.
I sold 5/6 of my position yesterday at a 35% loss. The remaining 1/6 will pay back all my cost basis if AGN ever hits $1 US. Not holding my breath. It's not the drug's fault, it's just really difficult to find any significance with 50 patients in a study arm on this particular disease.
Maybe AGN can sell Mark's ifenprodil patents but as far as your dream (and mine) of an outright company buy-out, I doubt it. Kal and his cast of con men will not look like a bright shiny prize to anyone at the scale of GSK or Pfizer. Peace, out.
Yo, don't forget the new Business Advisory Board - this party animal right here: https://en.wikipedia.org/wiki/Howard_Gutman
Merck's Gefapixant has a PDUFA date (FDA's self-imposed tentative Approval decision date) of Dec. 21, 2021.
https://www.hcplive.com/view/fda-accepts-nda-gefapixant-chronic-cough
If Algernon can get CC results in the next 90 days or so, you may see FDA get generous and set a similar up/down decision date for ifenprodil for CC. The challenge is recruiting enough participants currently diagnosed with chronic cough who want to be in a trial, during a pandemic.
As mentioned, the chances of an EUA for sars-cov2 are a coin flip and may take 2 months for FDA to announce up/down. The chances (my opinion) for Approval on lung scarring look great but no idea what the timeline would be as FDA would have to see enough positivity in the data mined from our currently locked Phase 2 trial, then recommend a Phase 3 architecture that can sufficiently power a study for:
1. sars-cov2
2. lung scarring
3. other long-hauler effects
Hope this helps.
PS - the mechanism for several other drugs recently discussed here (fluvoxamine, leronlimab, lenzulimab) to me - yes, doctorate - look very sketchy in terms of theory. The same way other failed ideas to me also looked sketchy - HCQ, azithromycin, colchicine, lopinavir-ritonavir. There was literally no reason to think they would work other than in-vitro suppression, if it was found, and case studies. Either of those reasons need solid (p < 0.05) statistical significance to back up what is otherwise an extraordinary claim of efficacy. Having said that, the list of currently approved drugs that have unknown or unrelated MOA but have shown efficacy anyway is very long. Something like half of approved prescribing is based on theory, the other half on evidence alone. We shall see.
CYDY failed, HGEN is next, competitors dying.
For comic relief, I invite you to skim over the Freudian denial that is sweeping through the Cytodyn bag-holder community:
https://finance.yahoo.com/quote/CYDY/community?p=CYDY
It's full of copy/paste 'letters' from either made-up or real MD's featuring impassioned pleas to Janet Woodcock at the FDA, begging her to not let more patients die. If the letters are real, it doesn't matter; the lady gets these all the time. Do they think she doesn't know they come from shareholders?
Too bad most of them didn't catch this article on their savior, the professor of mechanical engineering: https://www.bizjournals.com/portland/news/2020/09/17/embattled-cytodyn-ceo-is-undaunted-by-losses-setb.html
I believe Humanigen will be next to crash and burn. They have ONE cheerleader left, Cantor Fitzgerald. Who raised their price target - right after buying a ton of HGEN stock. HGEN's 3 month chart is ugly. https://sec.report/Document/0001214659-20-010872/
Yes, Algernon has its problems. But as M$ has outlined, its potential downside is ~35% while its upside at today's price is as high as 27x.
I bought another 4000 shares. It's the spike at 11:24. You're welcome.
E
Bonjour Monsieur Money $hot
To clarify (this is new to me) - Mark Williams developed and patented Diamedica's treatment agent DM199? As used in the REMEDY trial and REDUX trial? Gotta say that is some good work.
I agree that the recent activity with private placement and Mark leaving *before* the data read-out all points to the insiders expecting a very positive result and as you say, a share price in the $1 to $5 range.
I think getting AGN listed on the NASDAQ is a stretch but who knows - in a few years, maybe that's possible. Meantime I don't mind getting PAID out of the OTC exchange. Fingers crossed that is this month.
Yeah, Kal may still F over our near-term stock chart but I've got a strategy for that. Time to plan your work and work your plan kids.
Holding the bag with a grin on my face,
Dr. E
Look what happened to Pandion with today's buy-out by Merck.
https://finance.yahoo.com/quote/PAND/
Thank you M$
Mark's been a busy beaver. I got no issue with his 4M shares in the company; fingers crossed that's a 12M-16M USD payday for him real soon.
Yo Merck - hard times lately? Holla at your boy Chris, let's do this.
E
Recommendations frequently *are* made by a Data Monitoring Committee aka DSMB to end a study for lack of efficacy. The prologue, beginning, middle, and end of every clinical study is 'all worded up' with the ethical consideration of the study participants which includes not shuttling them to & from clinics for blood draws, labs, infusions, monitoring, etc for no good reason.
Gilead example
Dr. Wiki's write-up
This is actually pretty smart - thanks Mark.
From the February 5th Annual Information form which can be downloaded here: click YES to all the agreements
The Company’s early research program identified a number of genericized drug candidates as possible compounds for the management and treatment of new diseases. However, only drugs that were approved in Russia, Korea, Ukraine and Japan were chosen for screening. This was to avoid off-label prescription writing in the U.S. in the event one of the compounds achieved FDA approval. Off-label prescription writing can interfere with the normal economic pricing models and revenue potential of newly approved drug treatments and may make them less attractive targets for licensing or acquisition by a large pharmaceutical company.
^ This is truth. No country lets physicians write any drug for any reason nearly as much as the USA. It's like the Wild West was never tamed.
Really once you read down to the drug entities and studies done so far, it reads pretty well, while (to me) obviously being written by one scientist, with few or no physicians contributing, editing, or clarifying. Oh well. To continue:
In light of the Company’s current resources and limited experience, it may need to establish successful third-party relationships to successfully commercialize its future product candidates.
The long-term viability of the Company’s future product candidates may depend, in part, on the Company’s ability to successfully establish new strategic collaborations with pharmaceutical and biotechnology companies, non-profit organizations and government agencies. Establishing strategic collaborations and obtaining government funding is difficult and time-consuming. Potential collaborators may reject collaborations based upon their assessment of the Company’s financial, regulatory or intellectual property position or based on theirinternal pipeline; government agencies may reject contract or grant applications based on their assessment of public need, the public interest, the ability of the Company’s products to address these areas, or other reasons beyond our expectations or control. If the Company fails to establish a sufficient number of collaborations or government relationships on acceptable terms, it may not be able to commercialize any future drug candidates or generate sufficient revenue to fund further research and development efforts.
Even if the Company establishes new collaborations or obtains government funding, these relationships may never result in the successful development or commercialization of any drug candidates for several
reasons, including the fact that:
...and on and on regarding the risks to shareholders, for what looks like half the pages of this 63-page document. Again, if this many investigational molecules were being run in studies by Pfizer, the document would be many hundreds of pages long, but yes we are on a shoestring budget here.
The last part showing the number of shares and warrants issues is a bit nauseating. I'd feel much better hearing that ALL the warrants have expired but I doubt it. Again, please elucidate.
The ending about a lack of known conflicts of interest is hilarious but as we know, this is the bed AGN made & I jumped in it. Wow, now I"m sleepy.
Nite-nite Algernauts.
F*k me dead, this stuff is depressing.
Does anyone ever point Chris to this board and get anything more than a fake hearty laugh?
I thought Canada was supposed to be like America but with a soul. Now I find that Canada is merely well-positioned to pick our pocket.
Two takes for price of one.
1. For co vid therapeutics, here is some of AGN's competition:
IL-6 inhibitors trial
another look at same trial
investigational IL-1B inhibitor
alternate link
or Google PMID 33385581
Novartis defensive write-up
2. For P&D 5-day charts, look at the 3 most recent Chris Moreau initiated trading halts on:
- June 4, 2020
- August 8, 2020
- December 14-16, 2020, the mother of them all
There were other 5-day excursions with similar charts, like 16-21 July and 23-29 July 2020 (with a weekend) - if you know of anything CM released on those dates please elucidate. Peace
E
I think there's the Team, and there's Uncle Kal. He's like that crazy uncle you don't want to invite to Thanksgiving dinner because he always gets into the liquor cabinet and makes a complete ass of himself. But your brother & sister keep inviting him so you're stuck with his act, time & again.
Whether Chris is the one holding the leash or more likely Kal, this is less a united team and more of a dog walk. My take anyway.
I don't know how many shares the fat swarthy one controls or how cheap he got them. What I know of his previous penny-stock charades comes from longs like yourself and from his own website:
King Porn Stache
Disrupting the Dumpster
Completely agree that our zip-line to salvation is a buy-out. Hook me up on that ride ASAP please. No f*ckg way I want to hold through a Phase 3 as they struggle to enlist 30 of the 3000 patients they need to power for p < 0.05 - my pain tolerance pales in comparison to the true speculators in this stock. Not holding for micro-psychedelics either. It's a fkg story. Like the leronlimab story the CYDY crew tell each other at bedtime every night. Peace brutha
I get 3 posts a day (training wheels, yo) so I'll try to drop fresh takes.
Science? Yeah:
The AGN guys are amateurs. If you compare their team, their studies, and their submissions to the FDA it's second-grade spelling class compared to the mic-drop PhD-level flash produced by Moderna for their vaccine and Gilead for getting the Remdesivir EUA. But if Mark & crew are really effing lucky, they chose a sleepy little molecule that just happens to work, and we get PAID. But,
Pump & Dump? Yeah:
I learned investing from books, vids, and podcasts that never mentioned what a shit-pool that penny stocks are to swim in. So after pouring a decent chunk of my bank into AGN, more than 100,000 shares at 0.30, I find out there's this f*ckstick antagonist named Kulwant, who has 7.1 million shares. And I learn the candlestick pattern warning of a Pump & Dump. Typically 3 days of Pump followed by the Dump on the next day's open or in AGN's case, after a trading halt, breathless CEO press release read by tens of Canadian people, followed by BAM!!! instantaneous stock dumpage.
Example:
Damm, it feels good to be a gangsta.
Left: Kulwant Malhi, looking well-nourished.
Right: Michael S.M. Sadhra, bespeckled and whimsical.
E
Fair enough. Yep, I used the word 'you' too often. I concede your point.
Proceed to Phase 3 to me looks like the only positive information. But my take is: the FDA is fine with the safety of this and many other trial agents for COVID19, and for no cost of their own are fine with many firms like AGN continuing to look for promising data. A well-powered P3 would do that. But I expect the post-March 5 announcement to be weakly worded as that's all we've seen so far out of Chris.
I hope MedChem is wrong, I hope M$ is right. My strategy is somewhere in the middle of theirs. Preserve capital, don't risk it all, don't walk away early either. Peace
If Wednesday's drop tells us about sister firm Cannabix's price manipulation by Kulwant 'Kal' Malhi, why are you not concerned about him pumping and dumping AGN long before the March 5th data lock?
I've read a lot of your posts; it's hard to believe you will blindly hold your entire position past March 5th knowing that:
1) Kulwant had 7.1 million shares of AGN and apparently sold (dumped) all of them in December (then likely bought them back at 0.19 usd).
2) You're flat stating that he's pumping & dumping Cannabix. (P&D is often a 5-pump strategy over several months or years).
3) You seem to be aware Kal has a significant portion of AGN's stock and that he's getting inside info from CEO and CSO.
4) ... and that CSO/team are desperately hunting for statistical significance AKA 'signal'.
5) Absent strong 'signal' our friend (Hi Kal !!) will sell all his shares - probably right after another Chris Moreau-directed dramatic *trading halt*.
Please share your strategy for dealing with the above scenario without losing all of your potential gains. Or have you already made back all your initial investment? I want to play with 'house money' but that requires me to sell a significant portion during the run-up we will see in the next two weeks. Looking forward to your wisdom which is rarely found on this board.