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The UCLA clinical trial site changed from 15 minutes ago. The only trial for non-hospitalized confirmed cases is:
Evaluating the Efficacy of Hydroxychloroquine and Azithromycin to Prevent Hospitalization or Death in Persons With COVID-19
So, AZT added. Or, possibly I imagined the prior variant. Implications?
There is still a mono vs. combo trial for hospitalized patients:
Hydroxychloroquine Monotherapy and in Combination With Azithromycin in Patients With Moderate and Severe COVID-19 Disease
Thanks, your perspective changes my estimate of likely distribution of HCQ SAEs. Still, the non-hosp UCLA trials are neither megadoses or with zpac. Continue when we know more ...
Reading the study designs on the UCLA clinical research site.
For the non-hospitalized HCQ trials, anyone with a personal or even a family history of elongated QT interval is excluded. One has to note that a trial cannot properly measure the QT risk if it excludes those patients.
Still looking forward to the SAE side of HCQ treatment trials, with that qualification.
Data, data, data.
Thanks again, my small sample of docs was likely biased to cardio - you know the QT elongation thing with HCQ. I also know people who lived in Africa and took HCQ for years never noticing side effects.
Thanks, Misiu143. You are the first physician I've heard say that, given benefits and side effects, and used properly, HCQ is superior to RDV. Let me know if I misinterpret you.
Saying it again: IMO, a factor in Fauci's RDV decision was that it directed people away from HCQ, or whatever Trump would say next, saving lives in the process.
Would be wonderful if NP issued a statement clarifying his warrant exercise, stock sale (if it happened), and use of the proceeds. There are a lot of posts saying that the proceeds were used to benefit the company, particularly, by paying Samsung. It would be comforting for a lot of investors to hear that from NP.
"Impact factor," english language medical journals
NEJM 70
Lancet 59
JAMA 51
Nature 44
Thanks, tikotiko, Be there or be square.
UCLA Health - 23 patients and counting - the key to leronlimab credibility.
The UCLA Health clinical research website links to both of the randomized trials (mild-moderate and severe-critical) and a compassionate-use "trial."
The 23 "southern California" patients in NP's last presentation are all UCLA compassionate use - that's a lot of confidence to keep adding patients - now they see the results.
We don't know how many patients UCLA Health has put into the trials. But, hey, confidence.
I assume we'll be soon be able to refer publicly to UCLA. Nice.
How confident are you Patterson's article will appear Tuesday in JAMA? How solid are your sources? This would be huge to know with certainty.
There is a number called the "impact factor" for journals, which tries to measure, well, impact. On that score, the top 3 english-language medical journals are NEJM (70), Lancet (59) and JAMA (51).
Be aware there is one journal simply called "JAMA," and about 15 specialty journals. JAMA Internal Medicine, perhaps? More room for longer articles and discussion. There is an "online first" click-thru on their site.
I was a biostatistician way back in the 1970s - coauthored 8 peer reviewed papers - one was actually in JAMA. Honor, reputation, wow. I think I was one of only two non-MD coauthors in the entire issue.
Is this supposed to educate me in some way?
Correct, (using 4m warrants, a .65 exercise price and a 3.25 end of day share price), NP paid no cash and took 3.2m shares in return for warrants; he could have paid $2.6m and taken 4m shares - same value.
To file the form 144, he did have to have a "bona fide intention" to sell the shares "within a reasonable time," but he's allowed to change his mind. We've seen no evidence he has sold.
There is a deleted post that seems to say he either (a) sold the shares and used the proceeds (personal funds) to pay Samsung, or (b) pledged the shares to Samsung to assure payment. In either case, per that post, Samsung agreed to increase volume.
For starters, the FDA letter only applies to patients on oxygen with SpO2 <94%.
Second, RDV won't be available to blanket the country in a day. Current trials will have a window to enroll.
Third, your concern will indeed be addressed in future trials:, which wil be (RDV+another drug) vs. (RDV only). There will be no problem picking up the leronlimab signal in such a trial.
I didn't see that post - it was deleted. Certainly, he could have sold the net amount of shares he did receive from the the company, or taken out a loan with those shares as collateral, and then personally loaned the money he received to the company.
Not exactly. The company just issues him the net amount of shares - effectively he sold a portion back to the company. The usual clause uses closing price. That's what "cashless exercise" means on his form 144.
This way, only the net amount of shares hit the open market.
I still think part of Fauci's calculation was the clinical benefit of getting a lot of unfortunate folks off of hydroxychloroquine (and bleach, and whatever Trump would have recommended next).
"Q. If I file a Form 144, do I have to sell my shares?
A. A person filing a Form 144 must have a bona fide intention to sell the shares within a reasonable time after the filing of a Form 144. However, the filing of Form 144 does not prevent the filer from changing their decision about selling their shares or obligate the filer to sell their shares."
(per a law firm's "securities law 101" page)
What's a reasonable time?
"Cashless exercise" (as on NP's Form 144) allows the recipient simply to take fewer shares, rather than take all the shares and sell some in the the market to cover exercise costs.
For example, if his exercise price was $0.65, and the market were $3.25, he would take 80% of the shares and put up no cash. The shares would go into his brokerage account.
Also read that he sold 4m shares, BUT ...
Mostly, CEOs can only sell about 55 days each quarter (quiet periods usually start a month before end-of-quarter, i.e May 1 for CDY), and
Selling at the end of a day when you gave a complete public update, and allowed time for the info to disseminate, is appropriate transparency.
Calling it "insider trading" when you just gave a public update is self-contradictory. Stockaudit?
.Re: possible NP filing
My guess is that once the S-3a made those shares available for sale, some software picked up the link to his name in that document as CEO.
Under this theory, any reporting would in no way indicate intent to sell, but only the legal availability of the shares for sale.
Lawyers on the board - your view?
Reminder: RDV only authorized for Severe, defined as SpO2 <94% and requiring supplemental oxygen.
Worth reading the FDA letter. No impact on mild-moderate patients/trials.
"The remdesivir covered by this authorization will be used only to treat adults and children with suspected or laboratory confirmed COVID-19 and severe disease defined as SpO2 ≤ 94% on room air, requiring supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO); "
Warrant exercisers need to sell 20% just to cover exercise price. That's 9.2m new shares on the market even if they hold 100% of the rest. Over how long? Compound that with shorting.
That said, the share count has been growing over 10m per month for well more than a year, so we'll work through it.
Say you own 1m warrants @ $0.65, and want to help grease the company's path to the NASDAQ by exercising them.
Also say you don't have a spare $650k sitting around. At a share price of $3.25, you would have to sell 200k shares just to cover exercise costs. And that doesn't address taxes (do warrant exercises trigger recognized gain?)
Now say holders of 46m shares sold just enough to cover exercise costs over 10 trading days. That's 920k shares per day sold into the market.
Black Ops - I thought one bit was new - 46m shares of additional float (if i read the 10-Q right 29m happened before April 6th). That's over 750k per trading day of newly tradable shares since 2/29. Worse than short pressure. Pls let me know if I've got this wrong.
Hadn't heard of baricitinib, thanks. However, it's a small molecule, not a MAB, so it's not on Fauci's indicated shortlist.
Fauci stated clearly he wants a cocktail: Remdesivir to limit replication and an anti-inflammatory mab to address complications. Beyond leronlimab, tocilizumab is the only drug meeting that description.
Fauci is clear- he wants a cocktail. First, Remdesivir to reduce virus replication. The second is, very specifically, a MAB with antiinflamatory properties.
Besides leronlimab, there is only one other fitting the description: Tocilizumab/Actemra by Roche. It seems the wise route would be trials of each in combination with Remdesivir.
That's all we should ask.
The Gilead news may not turn out all that bad for CytoDyn.
Gilead set the bar for approval - survival, recovery, viral load, side effects. The bar has also been set that the FDA will act earlier than protocol.
When published leronlimab data improves upon Remdesivir in every category, it will be awfully hard to argue it doesn't deserve the same treatment.
Again, IMHO, Fauci was looking for anything with plausible data that will get people off hydroxychloroquine.
IMHO, Fauci thinking: ANYTHING rational to cut HCQ use
Re: lawsuit
If awards are rescinded, just fewer shares out. What's the problem for shareholders?
I don't think it is unusual to have different prices in different indications. Costs don't just include development and manufacturing. It's also appropriate that the (highly variable) costs of the relevant clinical trials should be amortized over the (highly variable) market size for relevant indication.
Expect erratic downward pressure from programs triggered from the "wall of warrants." Still 15%-20% potential dilution - small relative to the opportunity.
Quite the IL-6 reductions in the NEJM details.
We've been educated that leronlimab has more pathways to help COVID patients than simply reducing IL-6. That said, it will be hard for Kevzara (Sanofi/Regeneron) or Actemra (Roche), which only promise IL-6 reduction, to match leronlimab's results on that factor.
Per the detailed backup data in the NEJM, five of the six kidney transplant patients injected with leronlimab presented with high IL-6. On day 3, the patient with the highest presenting IL-6 saw it drop by 92%. Three patients saw reductions between 65% and 80%. The patient with the lowest (still-elevated) presenting IL-6 saw it reduced by 55% and was not intubated.
Kevzara's trial results are due "imminently" per Sanofi, Actemra trials are underway, and we know about the leronlimab trials.
There will be plenty of patients still to treat when results from all three are in.
NEJM more impactful on trials than patient testimony
The New England Journal of Medicine article will be far more impactful in filling trials than the patient’s video testimony, no matter how compelling she was.
Any doctor who reads the NEJM article (and nearly all COVID-practitioners will by Monday) will now consider leronlimab a legitimate possibility for the treatment arsenal. That wasn’t true yesterday.
Consider their (Montefiore’s) analysis of a subset of 28 of the 36 consecutive “severely ill” kidney transplant patients:
• 24 of 28 were administered hydroxychloroquine, along with another drug where d-dimer levels suggested it. Severely ill, indeed.
• 2 of 28 were administered tocilizuman (Actemra), a interleukin-6 inhibitor. There was no comment on their outcomes.
• 6 of 28 were administered leronlimab. There were about 80 words, along with a table, describing their outcomes. Presumably these are the patients NP previously mentioned.
• All presented with extremely high interleukin-6 levels, all of which “decreased markedly” by day 3. “However,” this improvement “only” prevented 1 of the 6 from being intubated. Is that a walk-back from NP’s comments? There were no remarks on survival.
I’ll take the “howevers” on this patient base. All-in-all, many more MDs will now be open to being involved in leronlimab trials.
VC -
Sorry to be a one-note, but it's not "magic resistance" it's the "wall of warrants."
For example, per the 10-Q, 30mm shares were exercised and sold into the market in 26 trading days from 3/1 thru 4/6. Mostly programs phase in above $2.60, though range is subject to adjustment. The last run at $3 appears to have resulted in far more aggressive exercises per day.
No diss on Nadar at all - but he is about to file an S-3 to increase max authorized shares. Duh! He's created a multi-billion dollar drug by raising $300m from people willing to share the risk. Out-freaking-standing.
So, warrant exercise today isn't totally bad - the vast majority will sell someday. My SWAG is that max overhang is now down to roughly 15% of shares, maybe a bit more if the recent financing ever converts at $4.50/shr (a high quality concern).
If anyone emails Nadar, asking his accountants for an update on footnote 17 would be great.
Check prior posts on the "wall of warrants." There remain about 15% of shares worth of warrants (my s.w.a.g. at this point), cost about $0.65, that are programmed to be exercised/sold, starting above $2.60. See footnote 17 to the 10-Q.
Patience! Climbing "wall of warrants" from low $2.60s.
My estimate is there is still about 15%-20% hidden share dilution in the exercisable warrants. It appears some of these holders have been exercising and selling programmatically starting in the low $2.60s, dominating the short issue.
Eventually this will be immaterial - look at the billions Gilead moves on COVID news. In the meantime, I share your frustration - patience, patience patience.
The Biospace "Clinical Catch-Up" article (with CytoDyn discussed before Gilead) may have more impact than the Yang interview. Having worked in the industry, I can assure you every business development person in every bio and/or pharma company carefully goes through that site daily.
Dilution is horrific, but finite. Science will dominate.
Whenever this stock crosses above $2.50, it hits the “wall of warrants.”
Per the 10-Q, the share count mid-January was 430m, 470m on Feb29 and 500m on Apr06, with another 140m warrants still out. Really nasty, but finite.
Absolute worst case, if they all exercise, share count will go up to nearly 650m, up about 50% from mid-Jan, when the share price was just over $1.00.
So, effectively, if you bought 1.5 shares in January for $1.50, you have enough shares to 100% offset maximum possible dilution. Not as good as a $1.00 cost basis, but not bad.
Using a w.a.g. of 80m-110m of warrants still out Apr21, we are getting toward 15%-20% dilution remaining to maximum.
BTW, even at $0.65/shr (per 10-Q), exercises will give the company plenty of cash – no new fundraising should be required.
Love the drug, hate the dilution. Can we climb the Great Wall of Warrants?
Check the 10Q:
-> the Income Statement shows they added 135m shares last year (432m vs. 296m)
-> Note 7 says 173m warrants were still outstanding on Feb 29, with an average exercise price of $0.65
-> Note 17 says, between Mar 1 and Apr 6, 29m of those warrants were exercised at an average price of $0.25
So, CYDY's market cap is growing phenomenally, but the appreciation in price per share has been limited. Shorts are at most a small part of the problem.
So, we have great news on a great drug. And a Great Wall of Warrants to absorb the upside.
I'm an individual holder. Do I have a chance?