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Imagine sending this protocol to FDA and getting it accepted.
Brazil has given their vote of confidence, at many levels.
Thankfully the market's sort of yawning. Seems this is not an earthquake news one way or other.
So long as all this is not more reason to destroy our SP. If this is supposed to be good news for investors, the market better react like that; otherwise not interested in the chaos.
That's why I wasn't sure either of his reply, whether he understood what I was talking about. But I would think however there would have been plenty of others who have already sent him mail on this.
As of now, it seems not the first thing in his mind that he seems worried about, as if it is a coup in the making.
(Emailed Nader; replied)
Me: [Subject] 13D filing
What is going on? People are saying this is like a coup. Are they trying to change the management, or what?
Can we pull through this without having our efforts to get LL into the market hindered and the company further destabilized?
N: Our attornies are not sweating this at all.
Me: Thanks.
[Don't know how or why, hope he saw the 13D at top and did not think something else by my usage of word "coup"; but he sounds confident at the least. Eases some stress. Don't want the market over-react tomorrow.]
Bottom line for me for these kinds of filings is the kind of effect on the stock price short term (this week) and long term. Some people are saying this will be good for longs, some are saying this is like a move to take over management.
How will the market react to all this? Positive because this pressure on management will lead to improvements; or Negative because this will create further instability??
Can someone explain in normal English what is going on here and why shorts think this is bad?
On the day of the FDA letter, the stock price came down hard. But since then it has not really drifted lower and lower. Pretty much it looks to be holding this level and slowly climbing back up. Usually if there is really bad news, the price will continue to go down after the first hit day.
Can we read anything from this behavior? Is the market saying that CYDY is undervalued and people are buying in at this opportunity (and shorts covering)? Why are people not buying into the shorts' predictions of bankruptcy, price going to 1.5 or below, etc., and selling further even after the FDA letter and its negative impact on our prospects? Or is the present support above 2 a normal chart behavior and no way to tell that it is likely to hold from hereon?
Misiu, did you mention of the FDA letter and that they should not get repulsed of LL because of it? I am afraid if they do take the time to check on LL online because of the emphatic impression you made on them, that FDA letter is the first thing they will see and they will not take us seriously because of that. Emphasizing on contacting the two doctors was very good; hope they listen and try. You can also send this writeup of your effort to Dr. Lalezari and Seethamraju, and suggest they can or should call Beth and express their viewpoints.
Yes, and May 18 he says again: "I still think it’s the drug I’d want if I were critically ill. Period."
Then the topic shifts to FDA's statements on CD10, the fact that Cytodyn said NEWS2 was SS and FDA negated. That puts Bream (and every long) on the back foot. The short said that Cytodyn did not publish CD10 results, hence likely they were misleading. Bream concedes he could be wrong at this point.
The discussion right there centered around CD10. Are we to assume Bream decided he could be wrong about CD12 and everything else that made him want LL for critical just a day back, now has decided he may be wrong on LL itself?
I am also upset about the NEWS2 debacle. But both FDA and Nader were/are playing with semantics imo. It is not the reason to start doubting the basics of LL for critical patients etc. Dr. Bream can very well take it like that; but the tweet's exact context is specific and limited to the question of error in FDA's letter.
Ok. That is correct point. There is agreement to partner for Covid trials but what that amounts to is still vague. Nader kept evading the specifics of trial design. We have to wait for further information of steps taken.
Yes and no. We have the formal agreements with Biomm and ARO-AEIH. That's not simply "forward looking" like if we are told of negotiations as if such will lead to outcomes. From Cytodyn's side, we have done what we should and the trials are on. If the trials are stopped later, it will likely be from Brazil side and a breach of the present agreement.
This was a forced CC. Not to report material progress but to offset the sudden unexpected impact from FDA letter. So it is not surprising that the team is mentally tired having to do it, especially Nader. He wanted attention off FDA and on the practical next steps that they are trying to focus on. To talk on FDA negatively is counter-productive, so refused to go that direction. As for his "forward looking statements", guess that phrase gives them leeway to project /suggest as they please, then become silent later on. Going forward we have to focus on what actually has happened, and take anything else as only suggesting possible effort from Cytodyn in those directions and in no way a likely successful outcome.
For now, Brazil trials are on. In India there is communication going on for possible trial. All this fantasy about EUA or even CSP, revenue etc., shareholders should not be talking about too much. Yes, we desperately wanted such an outcome following CD12, but by now it is getting clear this is going to be a long drawn process (till year end), even though many a person around the world could possibly have been saved if there was interim EUA. The not-pretty way this system works.
yup. Lot of spinning to get around the NEWS2. Oh well.
Hope people here know of this interview of Dr. Lalezari (saw in hangout). He talks freely giving "must listen" insight on LL, Cytodyn and FDA. I think this was before yesterday's letter.
https://savageminds.substack.com/p/jay-lalezari
Yes. I also hope so. Brazil is already committed with the trials; India I agree is capable of acting independently here especially given their situation and their past interactions: Macleods will be working overtime since yesterday; Philippines may have become more reluctant since their FDA seems directly tied to the US's; but lets see, we have been doing groundwork there for the most time.
Most likely the PR today was already in the works well before FDA letter; perhaps they decided to release it ahead of time, with urgency, given the action of FDA yesterday. Either the foreign agencies had asked for a Topline report focused on the critical patients, or Cytodyn proposed to provide such a report and the agencies agreed. And we were making progress and this topline report could have been an important next step.
FDA through its action however pushed itself in the middle and now there is really a lot of clean-up work that Cytodyn and its foreign friends have to do. The foreign agencies are also in a difficult position. We have submitted the report probably as per a mutually accepted plan; but their consideration may have turned lukewarm since yesterday. Lot depends on the type of contact and channels we have already established with them and how Cytodyn can work through them and keep their interest alive.
Yes I had sent them this question
Yes you have a point there. This is mild to moderate and quite possibly not everyone who signed up for the trial got treated because they recovered too quickly. Don't know how that works.
Officially we should have 75 patients in the trial for a 2:1 LL vs Placebo, actual enrollment however was 86. But we don't know how many actually were treated, since we did not get the details.
Cytodyn has to confirm on this. I am inclined to think FDA is playing with the semantics in an unreasonable way, to avoid giving any semblance of success for Leronlimab.
That's why I wanted to see if it is officially listed in the trial design. FDA knows what they accepted as secondary endpoint. Cytodyn has said clearly that they got SS in this, gave p values. So, let's see who is in the wrong. FDA has to correct the error or Cytodyn has to explain why not.
I got it from the site in your post: clinicaltrials.gov; searched. Thanks.
Yes it is listed.
2. Change from baseline in National Early Warning Score 2 (NEWS2) [ Time Frame: Days 3, 7, and 14 ]
This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). Higher scores mean a worse outcome.
https://clinicaltrials.gov/ct2/show/NCT04343651?term=Cytodyn&cond=Covid19&draw=2&rank=2
Does anyone know where we can get the trial design for CD10? We can check whether NEWS2 was formally listed as a secondary endpoint, and confirm whether FDA was wrong in their letter or whether Cytodyn had issued a misleading statement in their PR.
Unless Cytodyn did not really include NEWS2 as a secondary endpoint for CD10.
"The National Early Warning Score (NEWS) is an objective scale developed by the Royal College of Physicians to identify patients at risk for rapid clinical deterioration requiring critical care intervention. NEWS2 (the latest version), is being used as an endpoint in several other COVID-19 clinical trials, including CytoDyn's severe-to-critical COVID-19 Phase 3 trial."
(https://www.cytodyn.com/newsroom/press-releases/detail/458/cytodyn-announces-clinically-significant-top-line-results)
Reading this, one wonders whether they are saying that for many other trials, NEWS2 is used as endpoint. And after noticing it succeeded in CD10, decided to informally tell us it was a (typical) secondary that was SS for us.
Otherwise I can't explain how FDA would make such a crucial error.
"written by lawyers so you may not sue them"
They did a bad job then, leaving out NEWS2 SS and saying CD10 failed in all secondary endpoints.
https://www.cytodyn.com/newsroom/press-releases/detail/458/cytodyn-announces-clinically-significant-top-line-results
This is not a trivial fact. If Cytodyn had reported correctly that NEWS2 was a secondary endpoint for CD10 and that we had SS in it, then FDA should have a legal responsibility to issue a correction on behalf of LL and Cytodyn. Absolutely inexcusable. Nader and team should not let this go and demand FDA to correct the error.
The statement outlines FDA’s conclusion that the data currently available from recent clinical trials do not show leronlimab can effectively treat #COVID19
— FDA Drug Information (@FDA_Drug_Info) May 17, 2021
On the other hand, FDA because they were bugged by emails decided to make a move that will or could effectively devastate the shareholder and company's prospects. Can't say they are ignorant of the effect of this letter to the company and its investors - though the letter had nothing new to say.
The stuff FDA says here is not something new. They are repeating the results and the lack of statistical significance for the full trial. They spent the biggest para there on CD10 and why it was not good enough, then a short one for CD12. We know that already. Then they mention the subgroup info and the possibility of further investigation. The letter is a remarkable undertaking of FDA to slap us for the pressure public put on behalf of an OTC company.
We know all they said, are focusing on the subgroup based on CD12 and other eIND data, and have already started probing opportunities elsewhere.
Were the sellers (or any of us) really thinking at this point that US FDA was about to approve LL that we are disappointed newly? No. Situation here is very different from getting Trial Results or Dilution. This is more about bad publicity (albeit from the biggest voice around) than actual new information. And Traders sell when the same news gets circulated in new ways that highlight bad; and FDA has given them a reason to save or make money by selling.
The real Trouble for us as others mentioned is that Brazil, India, Philippines are all going to see this formal letter from US FDA. Cytodyn has to be smart about controlling the negative impact of this letter in those places. Lets wait for what the company says.
I take it to be a buyer based on what that quote said: 2.62 is closer to the high point of today's range and on the whole it was a price surge today.
But it is quite abnormal activity. Someone can buy or sell a million shares after hours at a fixed price on a stock like ours; who is on the other end of the trade? Or this is some hidden stuff that went through the day that has to be formally accounted for after-hours. Anywise, nothing "obvious" like justdafacts thinks. Based on today's price action, the likelihood seems a big buyer.
Thanks. Good.
Their focus is on "therapeutics" and we are a potentially key therapeutic for Covid critical and LH; likely their research team saw our potential in their preferred space and grabbed the opportunity:
"Our vision is to become a leading global pharmaceutical company by providing high quality, affordable and innovative therapeutic solutions for patients with diverse medical needs." "We are renowned for our expertise across varied therapies such as antituberculars, antimalarials, antiretrovirals, antibacterials, antidiabetics, antihypertensives and antiasthmatics."
Anybody know how "Big Pharma" this company is in India? The more their power and access in the Indian medical scene, the better our chances. For example, if Dr. Reddy's Labs became our partner, I would be thrilled because in my mind they are Big Pharma there with big clout. No clue about Macleods.
Market has been going down, I agree. Let's assume for Cytodyn as well, it is due to investors actually selling shares.
Investors of cytodyn are selling because investors of other blue chip, Nasdaq companies are selling? That does not make sense for our company; we are presently linked more to Covid based news than what market does otherwise.
But it is possible that investors have lost faith that we will make big money from Covid either, that Nader's short-term promises will come true either, and have decided that the short thesis is stronger at least for the next many months. Whether or not it is entirely our fault. It is depressing for a long; but we are having to retrospect seriously.
Even if the science actually is good, we have lost the peak opportunity in US and chances are it will be lost in India and Brazil as well in the next few months. That leaves a lot of uncertainty and nervousness.
That said, those still holding are hoping we will get some short-term prop in Philippines, some type of opportunity in India and that the drug gets validated/approved in Brazil trials. The risk of the wait seems higher now however. Nader needs to follow up on his free-lancing with substance. I would like to hear something clear about the 28 CSPs, and of course waiting for what he will say about the revenue, EUA application, etc. in Philippines.