I definitely think the critical trial will have better results but they below gives CD17 a solid chance at hitting it's primary endpoint:

From CD12:
Leronlimab improved the probability of “discharged alive” at Day 28, to 49% (126/259) from 43% (54/125) in the placebo + SoC group, a relative improvement of approximately 13% among hospitalized patients of varying severity at baseline (from those needing supplemental oxygen to those requiring intubation) with a p-value of 0.0697 using the logit model. (Table 4-19A).

This was with only 2 doses at day 0 and day 7. Reasonable to believe this will get better with additional doses at day 14 and day 21. Not much improvement needed to hit a 0.05 or lower p-value.

I think this was my favorite part:

The Questionnaire submitted from Mr. Rosenbaum is deficient in numerous ways, including the following:

a. Mr. Rosenbaum’s completed Questionnaire is missing page 5 of the Questionnaire form.

Missing an entire page from a questionnaire? This was the guy who was somehow going to lead the group to fill out the BLA correctly and right the ship? Must have left it in a hotel room in New Orleans...

Correct. From the below picture from the 8-k this is just the severe trail and not the critical trial. I guess that one is still under review and will hopefully be approved soon as well.

Looks like only the Severe trial has been approved so far?

Aren't they authorized to sell another something like 50 million shares? Which at the current price is over $75 million dollars? Bankruptcy is not even on the table until like mid-late 2022 and that's assuming they don't authorize more shares to be sold. Not the ideal scenario but saying bankruptcy by year end is absolutely laughable.

Just to be clear...that letter only stated that it has not been proven effective in treating COVID-19. It did not say that it has not been proven effective in anything at all.

They can't say that because it has been proven effective in it's Phase 3 HIV trial which would directly contradict anyone on this board who calls the drug saline or says that it is as effective as saline.

I believe what was said was that the trial originally had 30 people but Dr. Recknor wanted to add an additional 15 patients to get biomarker data. Nader was considering stopping the trial to look at the results of the original 30 patients because if it was solid data they could move on to Phase 3 and potentially get a BTD. Sounds like the additional 15 will be enrolled soon though and the biomarker data should help design the Phase 3 trial to hit their primary endpoint.

From what Recknor said yesterday it was not easy to get the dose justification done because they had to pull data from two studies. So maybe Mahoob was like "F this..." or maybe he told management that it was going to take 18 months and they said "F that..."

If the stall comes in the form of "We've finished the CD17 and hit primary endpoints" then who cares? Quicker revenue from that than the BLA. Recknor even said yesterday that if the FDA has additional comments to the BLA they'll get those fixed too. I work in another sector but dealing with government agencies is a pain in the butt.

IF the Brazil trials fail.
IF the BLA gets another RTF.
IF they don't get BTD for LH.
IF they don't get BTD for Cancer.
and IF they don't get BTD for NASH, then there might be cause for worry.

If any one of those things happens though...nothing to worry about at all.

As far as Recnor being there, it sounds like he genuinely believes in the drug having been administered it and seeing the effects. Even if that's anecdotal it made him a believer. I don't think Nader fires him. Remember, he's the only one that's been able to get the BLA in a position to be resubmitted so why would they get rid of him? They still have the LH Phase 3 and Nash Phase 3 that he's very much steering the ship on. Plenty for him to do if there is another delay in the BLA.

Lucky for us "marvelous" has a definition which makes it not subjective. Maybe you used the wrong word but that would still make me correct:

Marvelous: causing great wonder; extraordinary

In case you need it:

Extraordinary: very unusual or remarkable

Remarkable: worthy of attention; striking

If this drug ain't worthy of attention then what are you doing here giving it attention for? Maybe the Phase 3 HIV success wasn't enough proof but you being here giving it attention proves that it is marvelous...by definition.

Welcome to school.

Have a good night 3X.

So then my opinion of the word miraculous would, from my subjective point of view, directly contradict your assertation that there's no proof. I don't need your opinion when I've got my own about the fact that I subjectively think you're wrong...right? Thanks.

Any idea on the safety profile between LL and SG? I know LL hasn't shown any SAEs but did SG?

Not getting approval may be on management but meeting endpoints on the Phase 3 HIV trial directly contradicts what you said about there being no proof that the drug is marvelous.

As long as they have the entire thing submitted by October then they're back on track. Just because they rolled out a PR on mTNBC and haven't said anything about filing the other parts of the BLA doesn't mean they didn't do it.

I think the FDA has 30 days to respond to the dose justification that was submitted on June 30th and the company will start submitting the other sections after that assuming they get a positive response. All of those sections could be ready to go but they're just waiting on a response from the FDA...they would easily catch up on their timeline if that is the case.

What is he going to do to get the drug approved any faster than current management? If the answer is "there's nothing he can do to get it approved any faster" then there's really no benefit to me to bring in new management which seems like it would slow things down as new leadership and processes are implemented.

I think I'm to the point that this is current management's vote to lose. If they get the BLA submitted with no additional RTF, the Covid trials started in Brazil, or a BTD for mTNBC, LH, or NASH then they're getting my vote. That's a lot of shots on goal, any of which would benefit this company tremendously.

On the flip side we have a group that's given us no indication as to how they'll get the drug approved other than "they believe they can do it quickly". Dr. BP has been arguing on twitter with retail investors...this is not the look of a serious CEO so bash Nader for his past all you want, this is currently something that is happening with Dr. BP and makes him look no more suited to run the company than current management.

It may help the current management if I don't vote but I can't vote for someone that I have no idea what their plans are. Current management seems to have gotten some things on track although they are still quite a bit away from an approval. If they get BTD for cancer or start up the trials in Brazil then I probably won't vote for the 13D. I don't know that the timeline on the BLA will be completed before the vote so I can't really include that in my consideration although if they haven't submitted everything up to that point that they were supposed to it will hurt them in getting my vote.

If those things haven't happened and the 13D puts out a solid plan for getting LL approved then they could get my vote. If they come in with some vague thoughts or ideas then I will probably not vote. Sorry, you can't get the keys to the castle if you don't bring anything of substance in the form of an actionable plan. You don't get control of the drug (at least through my voting shares) just because Nader is screwing up. If Nader is screwing up so bad then it should be relatively easy for the 13D group to blow me away with their professionalism and a solid plan. So far I've seen nothing though.

New filing today from the 13D group. I haven't decided where I stand on the vote yet but this statement is just more bashing with no substance. They seem to just be pointing out issues but not offering any solutions. Their claim "current management has to go" is fine and all but this is the 2nd or 3rd thing they've released and not told me what they're going to do differently than current management. I can't vote for you if I don't know what you're doing. If they continue this approach I may just abstain from voting.

They may want to watch out with statements like this on below because I'm pretty sure they have no evidence to it being true and could open themselves up to lawsuits: Dr. Pourhassan’s and Dr. Kelly’s tenures at CYDY have been marked by a consistent failure to meet FDA expectations leading to a poor and unsalvageable relationship.

Unless they have real evidence from the FDA that this relationship is unsalvageable then this seems like a libelous statement that could get this group in a lot of trouble. To anyone thinking that the FDA statement is proof of this, that's incorrect and in fact the letter actually does the opposite with this statement: If CytoDyn plans further studies of leronlimab to determine whether the drug can provide clinical benefit to individuals with COVID-19, FDA will continue to provide advice to the company on their development program.

That is not an unsalvageable relationship. It's more of a "get your crap together and we'll take a look at new data" statement.

https://www.sec.gov/Archives/edgar/data/0001175680/000110465921094022/tm2122498-2_prec14a.htm

"So the conclusion that an LL treated patient whose symptoms re-emerge is “ the drug works, she just needs more of it”.

Please outline the steps that led to this conclusion. You actually made the opposite case, that it does not work."

The argument you're making here is that blood pressure medication doesn't work because you have to take it daily and if you stop taking it you get worse. Just want to make sure that was your intention.

I'm sure that Bruce Patterson is joining a proxy fight for a drug that doesn't work.

I'm honestly not expecting game changing news since the call is regarding the unblinded data from LH Phase 2. They're taking applications for the Phase 3 trial so at best I'm hoping for really good data from the Phase 2 but game changing would be approval and that won't come from this trial. Good news about the trials in Brazil and any news about the PO in the Philippians would be nice too.

Agreed. If the 25 patients that received LL have stories like the two testimonials we've heard that are positive and the 25 on placebo are all still experiencing similar symptoms as they were at the beginning of the trial then that might be something where the FDA is forced to give approval. I don't think that scenario is likely though.

Based on the information in the below article I think it's possible for approval from a Phase 2 trial but based on how small our Phase 2 trial was I think we'd need impeccable results like everyone on the drug got better and everyone on placebo still has LH in order to receive approval. Phase 3 is already taking applications though so even though it is needed at least the ball is already rolling.

https://www.raps.org/news-and-articles/news-articles/2019/5/almost-half-of-all-new-drug-approvals-in-2018-reli

Did I say that the company hasn't PR'd about the application because of what shorts would say? No, I didn't. I did say that if a PR did come out saying that they had applied that shorts would bash that too...which I noticed you didn't refute. My point was it doesn't matter if they've applied, it matters if they get accepted so I'm not concerned that we haven't heard a PR saying the trial has been applied for yet.

If they did a PR stating that Biomm had submitted the application to ANVISA then shorts would say "Oh an application to do a trial but it hasn't been approved? Just more hopeful statements and fluff from Nader." Biomm may have already submitted the application but who knows how long it takes for ANVISA to approve it? Unless you know the time it takes to get approved then you probably don't need to worry about the application until we hear if it's been accepted or denied.

Would you jump back in if Nader were replaced?

Is there anyone that doesn't believe that if the Critical trial in Brazil has 4 doses and makes the endpoints mortality or days in hospital that LL won't hit the endpoints with stat sig?

Am I happy that we have to sit through another trial? No but when the trials were designed last year Covid was new so getting it exactly right on the first try would have been lucky, not smart which is why I don't blame NP. Things could have been done differently but now we have the data to know what our endpoints and dosing should be.

If the Critical trial doesn't have 4 doses then I will agree that the majority of the team needs to be fired but if they do then I think we'll hit endpoints with stat sig and all of this will be behind us. There won't be any excuses about a "subgroup" when Critical patients are the only patients in the trial and you can see the clear drop off in mortality from when people stopped receiving LL in CD12.

Looks like it's 200k to India based on the 8-K

The 82% efficacy among critical patients wasn't a lie, it hit statistical significance. The FDA just said they wanted to see more data. They're going to be running a 300+ critical only trial in Brazil. I believe at one point Nader said they were going to make one of the endpoints number of days released from hospital which they also hit statistical significance on I'm pretty sure. This statement by the FDA literally says that these trials that missed endpoints can help to design better trails in the future. Nothing wrong with that.

He literally told people not to bother the FDA on one of the CCs.

Can someone explain how this is news? After the CD12 results were posted they didn't grant approval and Nader said they weren't going to without more data. This is just the FDA confirming it because so many people have harassed them. This isn't on Nader and it isn't anything that should have moved the share price because it has been known for months. This is on all of the shareholders that bombarded the FDA with emails and twitter posts. It doesn't change anything other than the share price for today though.

I think this quote by Mr. Agarwal is one of the most important things for this company and potential approval. The potential here is much bigger than in the Philippines in my opinion. Macleods feels their country needs LL and a multinational pharmaceutical company based in India should have substantial influence over the CDSCO. Those of you that don't like Nader should be happy about this because Macleods seems to be in the driver seat for our approval, not Nader.

I never said that I condone him making promises he can't keep in fact I said at times I too wish he would shut up. Starting to feel that way about a lot of longs on this board too. Would you prefer a CEO that was pessimistic? Back in January and February there were people on this board saying they needed more transparency and now the guy gives updates every two to three weeks and you don't like what he says. There's literally no making anyone happy unless the business makes them rich and to those people I'd say you've clearly never worked in business. There are no promises, there are no guaranties, there is no over night success. Why don't you go out and make your own company instead of riding on the coattails of a CEO who has gotten us this close to approval that you're so much smarter than? Stop whining and sell if that's how you feel or buckle down and chill out.

Please share your logical argument about how whining about Nader on a message board daily helps anything.

Please name who you think should replace Nader with proof that they've gotten drugs approved otherwise who cares.

Just sticking your fingers in your ears and yelling "Nader out!" without any other plan than hope the board finds someone better does not make you look smart.

I agree with you that I wish he'd shut up a lot of times, especially on CCs. If he owns shares though do you really think he's dumb enough to want to pump the share price up to $5 rather than land a deal and jump the price into double digits? I believe the science so I don't think he's trying to run a scam. I brought up Elizabeth Holmes because she knew she didn't have the science but she sounded good...I don't want someone like that.

I don't know, if the company from India really did approach us out of nowhere and can put pressure on the government to allow us EUA while running the trials in Brazil or a new one in India that would be game over. India could literally buy all of the product we have available and still need more. We aren't behind the scenes so we have no idea what talks or happening but if that were to happen no one would care about Nader. Everyone would be saying "the SOB did it in spite of himself!"

Maybe we could bring in someone who sounds good like Elizabeth Holmes...

How do you know that one of the hospitals isn't inking a purchase order for LL today? There wouldn't be a PR about that until next week but it would still be revenue this week. I'm not saying that's happening but you're not even allowing for that to be possible by saying "It's Friday, the week is over and he didn't tell me what's happening with the business so he's a liar and must be fired!" He can't make hospitals buy LL so maybe he thought there would be demand for it and there isn't since hospitals are liable if something goes wrong. It's Friday...have a drink.

So if there's no revenue this week but there is two weeks from now you think he should be fired? If there isn't any revenue ever from the CSP in PH then I agree with you that he should be out for saying that there would be. My point was that if it doesn't happen this week even though he expected it to that doesn't mean he was lying...it means he was wrong or it took longer than expected. You will never be a linebacker for TB, there's 0 chance of that. If some hospital doesn't get their paperwork submitted this week to order LL even though they are allowed to now, how is that a failed promise by NP? It's not.

Furthermore, I don't think there is a requirement for the company to PR once they have sales. That's only required to be shown in the 10k or 10q so you'd have to wait until then to know if revenue is real or not anyway. He could straight up say we have revenue on the next CC but you won't know for sure until the quarterly report is out so get ready to hurry up and wait.

NP never said we will definitely have revenue this week. On the CC he first said "We believe we will be a revenue company next week" later he said they will hopefully be getting their first orders this week and then even later in the call he said "our revenue will be reported in our filing at the end of the year and people are welcome to look at that".

So for every short saying no revenue this week means Philippines is done is just wrong. It doesn't mean he lied. He said "hopefully" every time he mentioned revenue this week because he knows it isn't a guaranty. Unless they already had a purchase order in hand things are subject to change.

Regarding India, he said definitively on Sunday "we can't talk about that until we put out a press release." Well, today we received that press release. Do you see the difference? India didn't have the "hopeful" statements. They were clearly already in talks in India and they gave a PR once it was finalized.

Longs shouldn't care that much if revenue comes this week, next week, or even the week after so long as we get it at some point. We would obviously like it this week but if it doesn't happen for another month, I'll still make money. I don't need to cash out today. Shorts need them to never get revenue so they bash every word that helps their case and ignore the obvious advancements that will bring their party to an end.

It will be fun to see what the shorts are going to use to bash the new trials. CD12 they claimed the critical population was a subset (which hit stat sig at day 14). Now one of the trials will have 300+ only critical patients so that excuse will be off the table for them.

Hopefully they will increase the treatment to 4 weeks from 2 and if they make the primary endpoint average length of hospital stay they will crush stat sig. Honestly though if they increase to 4 weeks of treatment and keep primary endpoint as mortality at day 28 they should still crush that as well.

Meanwhile, looking at revenue in the Philippians starting next week lets just be conservative...say 25 hospitals stock up on enough LL for 100 patients over the next month. That's 10,000 vials. If the company is only making $500 per vial that's still $5m in revenue. Anyone who thinks making $5m in revenue in a month, for a company that was previously not making any revenue, is a bad thing then they either don't know how business works or they have an ulterior motive and want the stock to go down. More importantly it's a potential of 2,500 new data points of people being treated with the drug.

I think I see the problem...according to your post you are an under 13 year old female who does not exercise. Otherwise you would have also been removed from the people considered and would not have come in first place. Are you an under 13 year old female or did you just have a really bad analogy?

The CD12 study was made up of 2 populations, the severely affected patients and the critically affected patients. Much like a race is made up of men and women. While LL didn't show great results in the severe population (male for the analogy) it did show an 82% reduction in mortality of the critical population (females) at 14 days. Not females over 60 with brown hair or any other crazy sub-group but the entire population of critical patients.

While I understand that day 14 isn't the end of the race, day 28 is, LL still out performed in the critical population with relative reduction of about 24% by day 28. While that doesn't show statistical significance, what that does show is that during the two weeks while receiving LL the critical patients were surviving at a much higher rate and the two weeks after they stopped receiving LL the rate of death increased.

Looking at the severe and critical groups separately is not data mining any more than splitting a trial into men and women is. There are a ton of drugs on the market that affect men and women differently but based on your rationale unless it works the same on both then it is a failure. If you have a drug that clearly works on sicker people (critical) then you shouldn't throw that data out because it didn't work as well on less sick people (severe). The only people who would seek to do that have ulterior motives. I don't think the FDA falls into that category, I think they simply want more data...but they have not said that it doesn't work or has no meaning.