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ANVISA approved the cd16/17 trials based on what they saw in cd12. Explain why they gave us two trials focused on very severe to critical patients and with 4 doses, if all they saw in cd12 is the gloom and doom you are picturing. If cd12 was total failure to be summarily dismissed of merit, what else is the independent basis for ANVISA to accept our proposed trials and allow the recruiting of their suffering citizens?
The clinical trials.gov website shows both trials recruiting as before, last updated Jan 4. Does that mean we have not dropped the severe trial or made changes to the critical trial? What about stopping at 50 patients for interim results? All that was Nader’s words as I recall (from last year, before Jan 4). Any chance we are already past 50 and are aiming to fill up the trial with more patients?
PS last post, I meant we should not dilute the critical trial by mixing it with severe. But the severe as defined in our trial protocol is requiring oxygen support, ‘non-invasive’ ventilation, etc. That should still be suited for LL; however ideally the two trials are kept separate as originally planned.
Does anyone know what changes if any were made to the original Brazil trial protocols in order to complete enrollment sooner? I was very encouraged by the initial versions that were approved by ANVISA, but later we dropped the severe trial and reduced the number of patients wanted for interim, etc. Did we eventually also lower/change the criteria of criticality that patients must satisfy in order to be accepted? Can someone list the changes in the present enrollment from the initial version?
If we were to go with earlier data’s best projected results and the original protocols, our best bet would be patients who are in the early stages of ecmo level criticality, getting started on ventilation. We really don’t have (from cd12 or eIND) promising positive data for non-ventilated ‘severe’ patients and should not end up including such patients for the sake of enrolling quicker, hoping 4 doses will work new magic. Too risky as Brazil is our last hope for Covid.
Omicron has pretty much taken over, and it is hardly the threat (to the lungs) that Delta was. If Leronlimab works uniquely best at the latter Cytokine stages of the disease, we might have lost the chance to prove ourselves with the right category of patients. The countries are still reporting deaths however; Brazil had 465 and the US 1022 deaths yesterday listed as due to Coronavirus.
Has there been research on how much Omicron related deaths can be linked to Cytokine storm and not other reasons? We likely won't benefit if the Brazil trial is filled (if it ever gets filled) with patients who are not actually entering this stage of the disease that was prominent in Delta.
Also, any particular reason why the US alone is still reporting 1000+ deaths a day?
We can grant that the FDA if it is acting sincerely and impartially is doing what they decided was in the best interest of general public. With regard to some of the quotes however:
“In the United States, we did a trial of 394 patients which included severe and criticallyill population. In the critically-ill population, our results were really strong. . .”
That is a sensible judgment based on the available results. There were 62 critical patients among whom the results can be judged as being "strong". By no means does this imply statistical significance for the whole trial or that the drug will eventually prove itself the same way in a larger trial focused on the critical patients.
Suppose we did a phase 2 trial on 62 critical patients and obtained the exact same results. And suppose the CEO of the company said, "The results were really strong". It means in the phase 2 trial, the results were very strong and that it warrants further investigation to establish the efficacy in the larger trials. The context is important. What Nader spoke of was pertaining to the 62 patient subgroup inside the larger trial; take it like we were looking at that part of the data as if it is a phase 2 trial telling how how to proceed forward. No crime there; FDA is acting it up in misleading ways when it need not.
“Our critically-ill population that we did in the United States when we gave a dose of leronlimab, the survival rate was 78%. Once we gave them another dose, the survival rate went up to 82%.”
Again facts. We are talking about the subpopulation in a larger trial. FDA looks ignorant by not coming to terms with the context of Nader's words.
We had 62 critical echmo type patients. 43 got LL+SOC and 19 got only SOC. At day 14, 2 out of 43 had died on LL arm and 5 out of 19 had died on SOC arm. Calculating, that gives 82% mortality reduction for LL over SOC alone. Fantastic and promising results; of course the CEO wants to highlight it. (I did not calculate but presumably at day 7 we got 78% reduction, suggesting that the second dose improved the result to 82% by day 14.)
Again, we are making the case that if we continued with 4 doses as we originally wished, the results may have been just as great at day 28. That is the basis for asking for 4 doses in Brazil and ANVISA approving it: ANVISA did not grant us the trial because they are stupid and the FDA is so much wiser. So FDA missing the thrust of our argument and simply and mindlessly pointing out the day 28 results (while avoiding the day 7 to 14 results when doses were given) to try dismiss the credibility of Leronlimab's potential is disingenuous. They did this in their first letter and they have followed it up in letter 2.
But this is not a court case; they hold the power and can flex it to have their way. Nor may they be inclined to go into the finer details of our results and think of possibilities; they simply saw the end-results and decided "fail". But because of all the politics etc. and public health chaos, they decided to make an example out of Cytodyn. Sure, fault Nader for this or that loose comment; but don't act like he was speaking out of the blue. We got 78 to 82 for the two doses; then the results worsened when the doses were stopped. So the shareholder and the drug maker both think of the possibility that results may improve if given 4 doses. Etc. Don't act like it is some tragedy that Nader wondered aloud numbers like 88 and 95, and use that to skip over the point he is making.
Reference: post 163447, https://investorshub.advfn.com/boards/read_msg.aspx?message_id=163593995
I recall reading someone's post that only 25% of Brazil trial or enrollment is complete. If that is the case, where do we get such information? Link and pg no.?
[Edit: Ok, it may be from this page https://www.cytodyn.com/pipeline where the drawing shows about 25% of phase 3 block for covid severe and critical. If the info is based on more direct data, let me know. The picture here is likely not current or updated nor meant to be taken in precise numerical terms.]
Biopharmcatalyst.com has Cytodyn (updated 2/3/2022) in its FDA calendar
“ Refusal to file letter announced July 13, 2020. Non-clinical and CMC sections of BLA submitted noted December 1, 2021. BLA to be completed during 1Q 2022.”
I hope so. I just expected (based on past behavior) some hint or mention of upcoming results in the 700 mg rather than absolute silence, in a proactive video that is meant to sort of pacify shareholders' concerns and questions. But if they have to get the formal report from the team compiling the results, before knowing or having anything to speak about, then it makes sense.
The proactive video makes no mention of the 700 mg part of the Nash trials. If there was anything good about the results there, I expect Nader to have highlighted that as something to look forward to. I wonder if LL can really be regarded as effective on Nash with 350 mg if it fails with 700.
Management should explain the 700 side, what happened.
If they unblinded the Nash trials last year, are they required to let us know the results within a certain number of days?
Is there supposed be a readout of some Nash results before the year end? I recall Nader saying it will be unblinded this year itself.
Can someone who thinks this news is significant explain whether it is any different than Holly Kennedy being allowed to get Leronlimab by her country last year? Its new for Canada to do so, so yes our recent data may be impressing them enough; but otherwise, is this not just another compassionate use or eIND case like we have many before?
Germany is spiking in cases, a new wave on unvaccinated people. Russia has been high, as also UK and US recently. Brazil however has been diligent in getting the vaccine to its people and cases have come under control. So unfortunately for us, we are in the wrong place at the wrong time. Nader already said we are going to focus on only the critical trial now - that is itself a big blow but probably a consequence of how well Brazil is doing: we are therefore directing all efforts to recruiting the critical patients. Let's just hope that somehow it gets completed soon and we obtain confirmation of LL's efficacy.
I also came in only after the Covid potential and have been focused on that indication till now. It is frustrating, and I am losing hope that we will get a proper chance to show LL as a real drug for Covid. I wish we could just jump into Germany or Russia now. After Covid, I do see good prospect for Cancer and HIV (if the BLA can really be fixed next year).
Same with me. Voted all the Board's recs.
I was so naively thinking the Board will win the vote (and 13D having less than 10% shares will not be able to block) that I did not even make the extra effort to get the votes for the other family accounts. Good lesson for the future.
It need not (and hopefully does not) mean trickery or conspiracy; but at the least, the process is not as clean as one would want. We cannot judge the extent of the impact of such inefficiencies; but given that the proxy got derailed this time, we also cannot trivialize it as being insignificant or non-existent. Just as example in my case, there is no reason that the broker should send one investor an email of the Oct 20 proxy but not another; when both got the Aug 24 proxy by email itself. That places fault at the broker's footsteps, but the consequence is some will simply not know about the vote and not vote. As you said, we have to be more alert this time around and make sure everyone votes.
A reference that affirms what that guy said:
"For certain routine matters to be voted upon at shareholder meetings, if you don’t vote by proxy or at the meeting in person, brokers may vote on your behalf at their discretion. There are stock exchange rules regarding which routine matters brokers may vote upon."
https://www.investor.gov/glossary-term-categories/shareholder-voting
Basically he said to check with the Broker whether something like this was afoot if we got neither an email on the proxy nor found that info inside our account webpage.
I went into my mother's Account to "statements" and proxy material, and now saw proxy voting links for all accts with CYDY she manages. They were dated 10/20 but the deadlines are 11/23; so they have updated and possibly removed the earlier links (if they were there before). Voted for all the accounts in favor of BOD; one observation is that Nader is not specially listed as CEO but just as among the BOD, which is probably normal process.
So at this point, I cannot say for sure that Fidelity had the earlier proxy statement inside the account on Oct 20 itself and we just missed it.
HOWEVER, checking her email, the last mail from Fidelity with the word "Contested" is Aug 24 (the white card mail). Whereas for me the last mail with "Contested" is Oct 20. So some sort of mess-up in the email sending is happening.
I expect they would not. I just quoted the email that was sent from morrowsodali to me when I said that the proxy email never came from Fidelity for my mother's account. So first question would be why one account got the proxy email and another did not. There should not be such variation in their procedure.
I am sure Fidelity will have an explanation; will send that later.
Nader talks and breathes Leronlimab daily and is working continuously under challenging conditions to make it successful. He is also a CEO who wants to communicate with his shareholders and not act aloof. I can easily imagine getting someone else there and deeply regretting later when I am all but shut out. I am fine with Nader, no problems placing my trust in him at this point. He is facing the fire. He may indeed have tripped or slipped to greed, arrogance, etc. but he knows he is on watch, that people who trust him hurt because of such poor decisions; his own conscience will know it. I will give him the opportunity to correct the past. My own selfish interests are included: disrupting the present setup may mean a long rebuilding process, whereas the present team if allowed some freedom may be close to getting job done. He first needs a proper chance to redeem himself and the company. What I am seeing is a hell lot of people - the anti-Nader cult - quite happy to screw my investment (i.e. happy/opportunistic to see failures right now including in Stock price) and place all blame on Nader: they are less worried about the struggles than about weaponizing them against Nader. 0 trust in these characters. I cannot see Cytodyn in such a precarious position right now if not for the unending efforts of moneyed people determined to destroy the company or this CEO. So, no way I will be blaming Nader for all that is going on negatively right now. If left a bit alone, we may see success soon enough.
Ultimately Shareholders will have to decide whether they expect NOW and in future that Nader will repeat whatever wrong or mistaken actions he did in the first go-around. I take the bet that he and Cytodyn have learned from their past blunders, whether born out of incompetency or out of greed, and have matured greatly in the past year of turmoil and will not repeat them; punishing Nader at this stage for what he did back then may feel good and be proper, but it is not in my best interests. The timing is horrible and the man is different now if at all he took selfish actions for his personal wealth before. I believe the team presently has full clarity of vision and purpose and will not repeat this sort of incompetent mistakes and selfish decisions going forward. Given that conviction, I cannot be foolish enough to seek to destroy Nader and put someone new up front especially when those vying for his replacement seem to be vindictive, angry, greedy, selfish themselves.
We have to wait for Nader's side on this. We can't simply jump onto some leaked info favouring one side of a court case and think they are entirely in the right.
If the BLA is known to have been given by Amarex to Cytodyn for doing its own review of the contents, before it was formally submitted to FDA, then there is greater reason why Nader and the Company must be held accountable for the BLA's failures. In such a scenario, They had it, saw it, failed to notice its deficiencies or did not care, and yet had Amarex submit it as it was.
If on the other hand, Amarex simply does its work and submits and the Company cannot know the contents until either after submission or after receiving the RTF, then we cannot be sure that Amarex did not mislead Nader and Cytodyn into a false sense of "Being close" or "just trivial aspects being short".
We would have to obtain more than a single selected email at the back-end of a whole bunch of others, assess the communications thoroughly before concluding who really is at fault and to what extent Nader is culpable for the failure. If I understand correctly, it was Cytodyn that initiated the law suits against Amarex; so hopefully (and probably) all these communications were thoroughly reviewed by their legal team before deciding there was merit in going ahead with the legal case.
I agree. This suggests a larger context. As others pointed out, we have to know the information given to Cytodyn by Amarex regarding what they were "short" on in the BLA, based on which they were continuing to delay and based on which Nader may written in this haphazard manner. Amarex may have hidden the depth of their irresponsible handling of the project and misled Nader into thinking "trivialities" were holding back the submission, because of which he urged them to get it done no matter what they were short on. Unfortunately he used Stock price and message boards as scapegoats for making his case and to create a sense of desperate urgency, and that has come back to bite him.
That's a guess. Even if above thing on Amarex is true, Nader can still be held accountable for trusting a CRO like this when it has been procrastinating and giving excuses and frustrating Cytodyn for long. The management should have wondered "What if Amarex was not telling them the truth?" I also don't see why Amarex would not give Cytodyn management an opportunity to independently review whatever they would file with FDA, before it is formally filed. Is there some rule like that, or did Cytodyn simply not do a good review of the BLA before it was filed formally?
So, has anyone verified these emails yet? Are they just "leaks" still, or do we have an authentic reference?
Like most people, I tend to accept that they are indeed Nader's mails. The one reason I hesitate is that the stock price chart around April 14, 2020 was hardly worth the ridiculous panic expressed in Nader's email. Let me know if I am mistaken below.
The high on April 14, 2020 was 2.77 and low was 2.47; that is a total % change less than 11%. Whereas Nader claims close to 20% drop happened in the first hour. This was on April 14, the day of the email.
If we use the April 13 close of 2.82 against the April 14 low of 2.47, even then the % drop is only around 12.4%, far less than 20%.
Now let's look at the price change between April 14 close (2.51) and April 15 Low (2). This is 20.3%. HOWEVER this is on April 15, whereas Nader's mail was April 14. Was he foreseeing the next day's happening???
Something is amiss about the numbers and the date of the mail. Certainly one possible explanation would be a botched conspiracy theory forging the mail. I want to believe based on the language that the email is true and then to figure out or deplore with everyone else, "Nader's foolishness" in the larger context; however the dates don't fit.
Also note that Nader mentions "yesterday" also there was a drop after great results. However on April 13, there was really not a big drop; only on April 14 and 15 were there drops over 10% and only on 15th was there a drop close to 20%.
We can also check on the exact day when they released "great results". Was it April 14 or April 13? [EDIT: I checked this in PR pages; it was indeed April 13. But that still doesn't explain the dates and % discrepancies mentioned above.]
Besides all this, the overall daily chart at that time was highly favourable (just March 26, price was below 1$). Unless Nader wanted to play some psychological games with Amarex to get them to finish up, it really does not make sense that he would panic in this manner at these prices. Perhaps he was fantasizing that the price stays above 3$ to get into Nasdaq, or something. Otherwise to react this way over a two day drop above $2, when the price was so recently below $1, leaves a bit of bewilderment.
Well, I sent ir the mail, but typically they don't respond. I was wondering if there was a standard practice to inform at 1 patient and then stay silent about further recruiting till we get close to interim; or if some companies do tell the shareholders on a continual basis.
Will Cytodyn be informed whenever new patients are recruited? If so, at what count will shareholders be informed? Are they bound by any rules regarding when such updates can be given? In the last cc, all we were told was that the first patient has been recruited for both trials; but I expect more for the severe trial by now.
IFRX developing drug for Severe/Critical covid; has ph 3 enrollment and new funding from Germany. Their phase 2 result is however based on very small data. See Oct 12 and 19 news:
https://finviz.com/quote.ashx?t=ifrx
They have enrolled across 9 countries. We need some good fortune in Brazil to get atleast interim results sooner, having come this far but finding enrollment stalling unfortunately.
At ~ 36:15, I hear the briefest couple of mentions of Leronlimab at the end of talking on a long list of other drugs. If the guy got this specific drug which is still not well known to the public and it helped him get over covid, one would think he will spend more time to personally make it well known. Too casual and ungrateful, or they are towing the pc line. He seems to say more about Remdesivir and Tocilizumab, including showing their pictures.
Did this Dr. Gary say anything about Leronlimab? I don't see why some of these "high profile" people (Erap, Greco, Gary) who took LL, got cured don't personally give special mention and advertisement for the special drug they took.
Dr Lim said something like it was good that LL was not given by IV and instead by subq. He probably meant it was easier from a practical standpoint. But our present position in Brazil protocol is that IV would be a more appropriate treatment for Critical patients. Dr. Nicolas definitely can suggest the same. Would Philippines have the option to try IV for Critical patients?
Dr. Lim gave a formal acknowledgment of the other drugs but did not leave any confusion in his conviction that LL was the turning point. That was important because unlike Dr. Nicolas, he appears to have newly learned about LL and speaking based on what he is witnessing presently in covid patients.
However the entire presentation tried to make it appear that it was about an alternative mix of drugs/supplements that worked for Secretary, which he wanted the public to know about. As if LL was just one among the many, or as if they are not supposed to state that the video was meant for highlighting LL. That is a bit disappointing. Greco in fact seemed completely oblivious to our drug as he mentioned everything else explicitly (including Remdesivir and Toci) but did not mention LL. Good thing Dr. Lim made a strong case for LL.
"The Company’s central focus remains on completing the BLA resubmission." (from the PR)
In the last cc or proactive videos, the impression I got was that Covid and Brazil trial is the thing to focus on right now. It almost felt like we were postponing the BLA since Covid is our quickest route to approval. Now, no mention of Covid and once again the BLA is central focus.
I am a bit paranoid that the recruiting is not looking good in Brazil, and am wanting some confirmation from the company that such is not the case. Hopefully today's PR is in no way a tacit indication that those trials may not be completed soon enough and we are trying to pivot back to BLA etc.
What I am having trouble with is the picture that our Brazil trials will recruit smoothly. Things have changed spectacularly in that country since we applied initially when it was looking like one of the worst Covid places in the world. I have asked management several times to address this in their public talks and they have not. As of now we know 1 severe patient is recruited and have not been told that any critical patient has been recruited. This is the major concern since even if we are confident that LL will succeed, the prospects of recruiting soon 100's of critical/severe patients is looking very uncertain. Is there reason to be optimistic that it will happen?
He mentioned of news coverage (or talk) in Philippines showing their increasing enthusiasm for LL. Anybody find something new on this?
I asked them over email to address the fact that Brazil's covid situation has improved and how that may impact our recruiting. They haven't addressed this point yet, but now we are seeing mention of wanting to get patients in US.. Did he suggest that we can add new patients from US for the same critical trial that has been initiated in Brazil - will ANVISA agree to such a proposal if the recruiting in Brazil gets too slow?
Unexpected fireworks getting thrown
New or old longs starting to buy back in, or Shorts panicking and buying out? Which is more likely reason for price jump today?
Much awaited news, finally. The company threw away protocol and sent the PR afterhours.
“one small step…” moment here, All bureaucratic and external obstructions have been crossed for this trial, now it is a matter of patients enrolling. We have to stay positive that enrollment will now proceed and we will reach completion of this trial.
How do we ensure that the drug does not deteriorate while waiting for weeks in customs overseas?
I was surprised that so much attention came back to Philippines.
Brazil still seems to be our main target, but I remain concerned that given their improvement in Covid situation, we will have greater difficulty in recruiting patients. We did not pursue US or India for the same reasons, so I don’t see how this is not going to be a growing concern for Brazil trials. This point was not addressed in the cc.