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I used 3-4 doses on EIND patients so I was not the one choosing 2! https://t.co/R5WzOtVOeg
— Bruce K. Patterson MD (@brucep13) July 5, 2021
Is there historical evidence of BP doing this kind of thing? If they intend to do a merger with a small company, will they try to manipulate short type attacks that help depress the stock price so that the company will be forced to agree to the deal at a lower price?
@MSNBC sEC needs to know nvestigate CytoDyn stock manipulation to benefit BigPharma coming merger. Congress needs to investigate FDA’s sabotage of Leronlimab trial by limiting requested dosage allowance. Delta variant tripling infections in last 3 wks mandates it!
— Paul Moore (@ftlpaul8) July 15, 2021
Leronlimab: too good to be true, but phase 2 trials w/positive results also continue for some forms of cancer. Rumors BigPharma lobbyists manipulating stock price allowing less expensive merger for certain indications. Delta triples infections in 3 wk period. FDA needs to EUA now https://t.co/uKW4VTIwY4
— Paul Moore (@ftlpaul8) July 15, 2021
Mail to IR and reply:
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What is happening with Brazil? You know, a lot of expectations hanging on the balance. All messaging has been as if the trials are going to start very soon, as if ANVISA will simply approve them. Never once did we hear a precaution that the trial may not happen at all. So yes, if company ends up trying to slide over Brazil and all Covid goals next, it will become new legitimate ammunition for shorts etc to point out how we are being misled. Already the stock price is taking massive beating; Investors are imagining as one of their main hopes that some good news on Brazil trials is going to turn the trend and are also very nervous what failure on that front will mean.
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Reply:
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All investors will be updated soon but due to SEC regulations I can not give information to an individual investor or a group but all shareholders at one time. I am sorry and thank you for all your support.
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Their stock price (HEPA) seems to have reacted awfully after the trial results were released. Not seeing offering news either.
Edit: something to do with dilution according to this: https://stocktwits.com/Tacto/message/356202620
Yes, they promised the trial then and delivered. From what we know, the PE was met. Looked like LL did work.
Then they promised to submit the BLA and did so. But they botched it and FDA returned an RTF.
This time around, they are again promising the BLA submission. But it is not the "same thing" as years ago. They made the mistake and this time it is correction; probability that it is done correctly now is very high because the care to not have a repeat failure will be proportionally high.
It is like a student submitting his final class project in order to graduate from high School. The teacher returns it saying it has spelling errors, typos, wrong font size, no TOC, etc. The student has the option of failing school or fixing the mistakes. He wants to graduate no matter what, and proclaims that the errors are correctible and says he will fix and resubmit.
If you think that student really doesn't care and just wants to make his family think he is working hard so that they support him financially etc., then you can point to the past failure as some fundamental character issue in the student that will likely repeat. i.e. Don't trust him this time also.
However if you believe the student really wants to graduate, then you can be confident that the second-time around is going to be very different with the way he focuses and fixes all the issues the teacher pointed out.
I am confident that Cytodyn is the second type now. What happened with the first BLA will not repeat. They will fix the errors and get it right. I also believe they have developed positively in their communications with FDA. Dr. Recknor mentioned this fact; it might have been in the context of LH but chances are he would have communicated likewise with FDA with regard to BLA resubmission. Read: toxic relationship could have improved since then (even if not between Cytodyn investors and their reading of FDA actions against them). So, on that front also, I would think we are in no way comparable to the less mature company of the previous occasion.
All that does not mean that LL will get approved for HIV. Ultimately we have to win in the contents and all we know is that FDA has not addressed this question formally. Except for the ROT requirement. How central that is to the final decision, we have no way to tell. Perhaps Dr. Recknor can present enough data and add further justifications to go around any inadequacies in ROT data, and that is why the team is going forward with confidence. At this point the investor has to trust this much and let it play out. Don't imagine a new management will create magic when the data is what it is.
As for the apparently more substantial data that is the phase 3 trial results, we have to trust that we met the end point and FDA will not fault the contents of the BLA in that regard. Changing management is not going to change the trial results, and the right course of action is to have the FDA look at a properly submitted BLA and come to its conclusions on the results. Now is not the time to be pointing to the past and screwing the potentials right before us.
Brazil trials getting green light is a cross-your-fingers situation. imo Nader and management have done their job from this end. But ANVISA has to approve. That's a question mark till we see it happen.
What happens to our BLA and approval for HIV if FDA approves the Gilesd capcid drug first? Will we still have the same chance at approval based on our corrected BLA?
If we are now competing against Gilead’s capcid inhibitor, how did that drug perform in its phase 3 trials compared to LL?
Finally this person tweets that 2/3 of blood samples from our trials were not saved, hence we cannot do the ROT now? Is this true and how then might Dr. Recknor fix this? Somebody can mail him and ask on this.
Yes, I recently learned this as well. The main issue is that a previous lab, before InCellDx, did not save blood on 2/3 of cases. You can’t do ROT! Rather you need a scientist such as Dr Patterson to work w FDA on alternate options for HIV BLA approval. @brucep13
— Donna (@Anonymous_0004) July 8, 2021
Check out the graphs of nvax and MRNA, both got to 3 digits in a couple of months, in gods green earth. Mainly on Covid hype and even before the vaccines were out. LL theoretically has potential to impact in multiple major indications, so definitely 3 digits is possible depending on its efficacy in these indications. However without doubt at the time, I was also quite upset by his three finger “shenanigan” to koin 6 news. Whether it was a calculation meant to offset the cd12 results or to keep eye on larger picture, or he was just answering without proper restraint and awareness of that moment, it did not look good. At that time. Now I can’t say I mind as much. We are here because we believe this drug works or really has that potential. And there are forces committed to destroy it no matter what, so at this time, we cannot be fearing how such entities will use and abuse this or that statement of Nader. The man is committed to the drug and we are looking forward to the goals set for this year.
My post was not about whether he did the right thing from the company standpoint in the long-term sense.
You can call it incompetent. In retrospect, given how things turned out after the short attack and trials and now, of course one wishes they just did the offering and cared not for the new investors who bought above $5. But generally new "investors" hate it when a company hits them with an offering. Keep in mind that stock price did not go up based on solid results, but on covid hope and hype.
But I see it as a deliberate decision; if he wanted to raise, they could have done so. They did not. What was the thinking?
One possibility is it had something to do with that philosophy of not screwing shareholders by raising money in such and such manner. (What that "manner" was will be a matter of speculation or partial information; I don't know what all the variables were.) The decision not to do hard offering at that time would be consistent with such an idealism there. It may not be the only factor but it is reasonable that it was one of them.
Now, you all producing this or that other example - as if you know all the ins and outs of such decisions - need not negate absolutely the possibility that Nader indeed is nobler than you make him out to be, that a lot of what he said in that proactive video of his philosophy and money-raising approach is indeed true. You can make your case and imagine you proved things about how anti-shareholder and self-interested he was. I don't buy the simple picture.
That sort of allegation is too simplistic. I allow for nuance to exist, beyond what they post in the website. With your chart, that much I take as definite.
Good reference; thanks.
Can someone tell when Nader was demoted from CEO and when he was promoted back to that position?
When asked about financing issues, Nader often makes a point (including in the latest proactive video) on what he did do to obtain financing without excess dilution and how before he had come it was diluted by the hundreds of millions by earlier CEO. I do not think of this much since I am not actively wanting him deposed; I am more concerned about the trials, BLA, etc.
But in retrospect, given the pile-up of attacks on the company and him based on the financial decisions, I realize it makes a lot of sense that he himself outlines what he/they have achieved on this front.
It is easy for shorts (and anti-Nader longs) to just assume "All he said was a lie" and to negate or just stay silent about this positive successful work of Nader to save our money and shares.
But suppose instead we assume that what he said is truth. What does that mean? We should not merely mention that he personally profited "by stealing shares" or took decisions that cost shareholders in these lawsuits; that has to be juxtaposed and compared with the financial successes to get a fuller picture. The accusations of financial failure pale in comparison to the successes.
From 4:20 in
out-of-context pivot off some phrase to ‘attack’ me and then Nader/cydy based on something else.
Thanks. That does make the system clearer. SEC was correct in calling out Cytodyn for tagging "clinically proved" based "solely on the results of our clinical trials". I probably read too much into Cytodyn's statement on FDA not asking or commenting about the science of LL; it only means that the RTF is not a black-mark directed at our science - the same trial data suffices and we can fill in the gaps.
For longs, we should anticipate that Cytodyn will correct the deficiencies and complete the BLA filing again. But that is still the first step. FDA then has to affirm safety and efficacy from the data in their full review.
That was my take on how Cytodyn tagged "clinically proved" when it mentioned of Leronlimab's safety and efficacy. That would be a simplistic logic (since "science" is not mathematics). SEC said No to it.
If you meant something specific, state what is true and what exactly is not.
I think your reference is the May 24 filings of SEC and Cytodyn's response.
My take:
The later issue was whether Cytodyn can state "safety and efficacy" based on their own analysis of data and due to the fact that FDA did not raise questions regarding them in their meetings with the Company or in the RTF. Cytodyn is clear that the FDA's focus during the meetings or the RTF was not on the Science of LL with regard to safety and efficacy but on other data-devise related issues etc. However Cytodyn assumed and stated based on its own analysis of data that the safety and efficacy were clinically proven and that the lack of questions from FDA in this regard meant they were also in agreement with the science being clinically proven in the trials and only wanted additional and subsidiary data to complete the picture.
If the FDA had any doubts on the science when they looked at the trial results, surely they would have addressed or mentioned of them in the RTF. That is the logic. For example, if the results give the right p-value and hit the agreed-to primary endpoint for establishing safety and efficacy, then technically the science has "clinically proven" the conclusion. So Cytodyn may take that as sufficient basis for making such claim given that FDA also did not question this part.
SEC basically disagrees with this and has told the Company that they cannot assert safety and efficacy as clinically proven until FDA formally posits the same. Cytodyn has since agreed to change the language used henceforth and SEC has accepted the filing.
As far as Cytodyn is concerned,
1. Our analysis of data shows ("we believe") safety and efficacy. But we cannot formally state the same as clinically proven since FDA has not yet confirmed formally.
2. In the RTF and meetings, FDA never questioned the implications of the trial results with regard to safety/efficacy, never cast doubt on these conclusions.
3. FDA however wanted more data, better presentation, etc. all of which Cytodyn believes can be done and is presently working to accomplish.
Nothing further to this. We are on track.
First time I am seeing this response to SEC:
https://www.sec.gov/Archives/edgar/data/0001175680/000119312521155052/filename1.htm
Clear and strong answers; confident that the RTF does not negate the validity of the science of LL and that they can correct the data/device-related, presentation, completeness issues.
Most of the dump happened in the last hour. About 1.1 million shares in a short time. Likely a few big sales from a few individuals rather than a general market panic among longs. There was sell pressure earlier in the day slowly building and testing; but a decisive move at the end.
We lost 6% of the price (1.62 -> 1.52) when only ~ 0.14% of the float size (1.1 mill shares out of 800 million+?) got traded. It suggests that the price got pummeled by a relatively small volume of trades while most are on the sidelines waiting for news and getting harassed by fear of the wait.
I am thinking however that it was honest transactions of some people wanting out and not a deliberate attempt (of shorts etc.) to manipulate the market price. Can't tell. We have to see if this sets the ball rolling for further sells from other big pockets in the coming days and to what extent that diminishes the price. The other concern (if the support break did not happen by short attack) is that shorts may use this support breakdown as the right time to jump in a coordinated attack in the coming days - i.e. price manipulation may follow.
See, I write something on Dr. P’s recent tweets and people here turn it into their usual splill on Nader. It was all cute and scientist talk before, but now that he has taken side with an anti-Nader group, if he wants to refute assumed allegations on his actual role in RO or in seeking a buyout of his company, then he needs to be precise and complete or as I said he will soon (or by now) come across as suspect and partial. I actually made the comments because I think of him as a good person, but not necessarily as completely clean in all this “what did Nader insinuate?” business. Better silence if you (BP) don’t want to muddy your own reputation with murky tweets of this sort.
As for Nader, sorry I have experience only of a year and few months. I look at management not by whether Philippines approved LL but whether they got things to the doorsteps there. Not by what ANVISA does next but whether we got the papers to their desk. Not by trial results but whether we got trials underway and completed as planned. If it doesn’t go according to our expectations and it can be pinpointed as our management’s incompetence, then I will question more along those lines. I am not competent to judge if they have already messed the trial design, but no one else either is complaining now on that front. I can’t put it all on Nader if later ANVISA asks for changes, or Covid landscape changes etc. For now, going by the info I have, management has done its job very well in Brazil. Beyond here and to the end results, there are many variables at play that are management independent.
I also don’t blame management for FDA putting out a crippling letter like out of shorts’ fantasies against an OTC company and its inestimable negative impact wherever Cytodyn is trying to make its case. Management completed cd10, cd12, LH ph 2, and have in each case made the best possible case for LL. We are still afloat in our Covid goals and all credit to Nader and his team for that. NASH enrollment initial phase is complete, tnbc also(?). Management got that done for us and are moving to the next steps that may obtain results this year. And a timeline is given for BLA and they got the first step (dose justification report) done there as well. They are doing their job in full earnest as far as I can tell. NOW matters now. I can’t be looking to pull them down based on what they failed years back, not good risk vs reward approach for me given what (the potential goals this year) I am looking at presently. IMO they have grown from past mistakes and are doing things in good manner now.
your 13-D will not sell with investors if your main attraction Dr. BP himself comes across as suspect, partial and opportunistic. You are already decided that Nader is like that, but those who would rather go with the management are saying that given the chance and situation, the 13-D bunch will be just as bad or worse than what you imagine of NP.. So, don't be comparing back to NP as if that will help defend BP. BP's words referring to Cytodyn will be measured with the perfect standard that 13-D acts like they will deliver once in power. Better ask BP to stay silent or be complete, which was more or less my point. This riff-raff tweeting can come back to bite.
Nader's total commitment to the cause of getting LL marketed is beyond my suspicion; I have no doubt about that. Other things I believe the present management is getting together fast. And we have too many potential milestones at work right now to be stirring the pot this year. Wait it out. The Group's working hard.
My point was not about whether there was FDA conspiracy on RO. It was more about Dr. P's tweeting methods and I said my bit in the following posts. Not meant to be profound, just my personal opinion on how the tweets come across at this point when he is joined with 13-D team and how it would be better for him to communicate on these points directly and independently.
Nader did say "main problem was receptor occupancy test was very poorly done". So if we assume he is telling the truth that this was the major problem, I did ask earlier whether this was a jab at Dr. Patterson; what exactly did he do and not do with respect to RO for Cytodyn; or whether Nader was just admitting that Cydy (as a group) had messed up and not really pointing towards Dr. P.
Replying to select tweets is not setting record straight. It is using the platform in an ambiguous and extremely limited manner to give as much/little information as he wants and no further if he does not want; a PR campaign of sorts which can damage his credibility at this point (since he has joined 13-D). Some internet guy says this is what Nader is insinuating about Dr. BP, then Dr. BP acknowledges the same as if factual and negates it in a partial and confusing manner.
Even then, he can do that independently in his own tweets (or formal letter) and in a complete manner - if that is really his intention. Given that he has joined the 13-D team which is trying to put up a professional case for why management needs change, Dr. BP also needs to be professional and commit in his way of response if he wants to be taken seriously. If he wants to support that team, then pinpoint the possible charges that he feels Nader (and pro-management investors) is making with regard to his role in RO (and other interactions with Cytodyn), and refute them systematically and thoroughly by stating what exactly he did during his partnership with Cytodyn and what he did not.
Otherwise it comes across as being suspect and partial.
I accept his tweet on him not having anything to do with dosage being 2; but the RO reply leaves one wanting of details.
Exactly! Finally someone has found the truth! Second we used PRO140 for our RO assay so if it didn’t work that means PRO140 must not bind to CCR5. Hint-it does and it’s a great assay. https://t.co/bBhbGVCiWU
— Bruce K. Patterson MD (@brucep13) July 6, 2021
Dr. Patterson is engaging in back and forth on twitter:
I used 3-4 doses on EIND patients so I was not the one choosing 2! https://t.co/R5WzOtVOeg
— Bruce K. Patterson MD (@brucep13) July 5, 2021
Was he referring to Dr. Patterson when he mentions Receptor Occupancy? And anyone particular in the reference to badly done Dose justification?
Nader seems to be throwing some punches at people who 'did not do a good job' earlier. "main problem was receptor occupancy test was very poorly done" - is that a jab at Dr. Patterson? And the report for dose justification "did not do a good job that it should have done." Dr. Rahman probably came after this happened but did not do the expected work after coming on.
Expected a lot more price action than this.
Replies:
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[my name]
Thank you for the kind words and for your support.
Best,
Scott
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Thank you, [my name], and yes, we believe in the timelines
With best regards
Nader
I just send mails. You can too. Replies are rare.
Sent this mail to Nader and Dr. Kelly:
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Did not foresee this letter from the 13-D group. I would not have sent the mail yesterday if I thought this was coming. I am not jumping ship. I get there are barriers and obstacles, mishaps and missed opportunities; but also believe the management has grown from them and are steering things in right direction. Primarily, even though the compensation assertions of shorts does irk me as an investor losing money, I do believe that you are truly sincere and committed for our common cause: convinced that LL works and seeking to get it approved.
This is not the time to surrender or run. I will not and I hope you do not. You have stated the goal-points in the 8-k; just get them done as planned. That is the only way to silence the critics. (I will have to assume 2 things: 1. you really do believe these goals are attainable and are not merely stating them to bide for time, and 2. you believe in 1 because you really believe Leronlimab works in Covid, HIV etc. and would be approved if we can cross the paperwork and red tape. Hope this is indeed the case.)
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Glad to see that they have done the dose justification report by the deadline.
The referred letter from yesterday was a frustration mail, something I send every now and then.
It was not pre-approval. They mention this in page 4. They say the "Models for raw ordinal data would not converge" whereas for the present repeated measures model, it does converge. From what I heard at the cc, they will propose this model to the FDA for granting phase 3.
Based on wikipedia, this is a standard way of assessing data: https://en.wikipedia.org/wiki/Repeated_measures_design
Note among the stated uses:
"Limited number of participants—The repeated measure design reduces the variance of estimates of treatment-effects, allowing statistical inference to be made with fewer subjects."
So we need not assume the entire model is adhoc. It is probably a standard model that FDA can accept as valid. And for this small trial, it probably would have made sense to use such a model.
As for the weighting score, that may appear simple or concocted but it is straightforward: severe should receive a higher score than moderate etc. So give it score 3, moderate 2, mild 1, none 0. Higher total score, worse the evaluation. Such a weighted assessment does not seem outlandish by any means; not to me.
Cytodyn is not doing something wholly deceptive by using such a scale. It is one simple scale and one standard model that shows Leronlimab works better than placebo for a good number of symptoms. If FDA thinks it is not precise enough to make conclusions, they can suggest otherwise.
16 tables were not filed; I see tables for 8 out of 24 symptoms. Likely these 8 showed statistical significance (following their model) and 10 others showed "clinically meaningful improvement" as said in the PR. Agree that we cannot know what to make out for the actual numbers in those tables not shown, except that their end calculation showed something better for LL over placebo.
I also don't know what they mean by "baseline". Is that the score on starting day?
For the raw numbers in the shown tables, note the difference between baseline and Day 56 for LL arm vs placebo in the Severe case:
LL Placebo
joint pain 2 -> 0. 3 -> 1
tightness. 6 -> 0. 3 -> 2
Numbness. 5 -> 1. 1 -> 1
Weakness 5 -> 1. 4 -> 2
Sl. disturb. 10 -> 2. 8 -> 4
Headache. 5 -> 1. 4 -> 3
Short breath. 5 -> 0. 3->2
Nausea. 1 -> 0. 2 -> 0
Granted the entire evaluation of these things looks very subjective (patients scoring themselves?) etc., still for the above symptoms (other than nausea), in the severe case, the raw numbers show there is a MASSIVE improvement in the LL arm compared to placebo. How (looking at the full tables) are you concluding the raw numbers are not impressive?
Possibly by doing biomarker analysis, Dr. Recknor will deduce more detail behind the chemical activity of Leronlimab that caused these dramatic changes in the severe case for these symptoms.
Two things projected to happen by today, in 8-k. Pg 23&24
Draft dose justification submission (date written in Bold letters)
Completion of initial NASH enrollment
Hope they send a PR affirming the first by Friday and the second within a week.
Covid was a tremendous opportunity, given the potential efficacy shown by the eINDs. There are several companies especially in the vaccine side (NVAX, MRNA) that have skyrocketed. Others like Gilead have sucked in huge profits. Given the promise shown by the eINDs, it would be non-sense to not do the pivot last year. Not to mention, that a sub-dollar stock saw $10 in short time.
We missed the mark possibly in the design of cd12 (perhaps should have focused on critical alone, or split into two trials for severe and critical separate). Now, it is easy to fault the enitre move in retrospect given that it has not (yet) worked out.
I figured out a good part of it:
Baseline (I am guessing) is the initial scoreline for patients at the time of entry
Day 56 is the evaluation at Day 56. Or it is based on an average of the daily scores till day 56. In the latter case, the scores of a patient may be averaged over the 56 days and if it (for instance) averages to 2.6, the patient would be considered severe; whereas if was 2.42, it would be rounded below and the patient would be regarded as moderate.
Each patient is evaluated (don't know how) for whether their condition is severe, ..., none. And accordingly there is a score assigned: severe = 3...
The entries in the main columns are the number of patients who are evaluated as having this level.
Take the table for Tightness in Chest.
There were 6 patients in the LL arm who had severe tightness in chest at the baseline and by Day 56, there were 0 LL patients with severe tightness. Whereas in the placebo arm, 3 at baseline and 2 at Day 56.
Likewise for the other 3 rows.
The 5th row (which shows 16 for Day 56 and 35 for Baseline) is the Total Sum of the Scores for the patients at Day 56 and Baseline.
So for Day 56, the Total Score is 0 x 3 + 4 x 2 + 8 x 1 + 16 x 0 = 16 (since 0 patients had score 3, 4 had score 2, etc.) Similarly for LL baseline, total score is 6 x 3 + 5 x 2 + 7 x 1 + 10 x 0 = 35.
The net change in score between baseline and Day 56 is 16 - 35 = -19 for the LL arm and 19 - 26 = -7 for the Placebo arm.
The % improvement between placebo and LL is (19 - 7)/7 x 100 ~ 171 %.