Hi Latane, you answered your own question here. Of course the FDA is corrupt. It's no surprise as money talks. It's really as simple as that.

A small biotech with no DC clout is not going to be allowed to show up big pharma. It just ain't happening. Especially when decision makers are in the pocket of big pharma. The only science they care about is their own science. Otherwise, it's their job to suppress any competitor that threatens them and their livelihood.

The best bet here is to sell to big pharma for Covid purposes only and then concentrate on HIV and the other indications. Personally, I wouldn't mind an out-right buyout at this point. But that's just me.

What are you talking about? Your post has nothing to do with what I said.

Because the president doesn't have any skin in the game when it comes to Leronlimab.

If CYDY had any lobbyist up there to grease some palms... it would have been mentioned a month ago by POTUS. It's the way it is.

NP did say that if he isn't doing the job, he should be removed as CEO. So when is he stepping down? That position needs some new blood.

Thought the Type A meeting request was submitted two or so weeks ago. Seems they'd have closer to 14 days to respond.

And yet, mysteriously, no meeting. Another can kicked down the road. I guess we'll see. Hope I'm wrong but I say anything less than approval, we continue to slide south. I won't be surprised if the 10k isn't submitted today.

They need to get to the S/C interim and soon. Are they still short of trial patients? This approval for M/M just ain't coming. Dr. Jay knows it and he knows that the big news hinges on S/C trial results. Can't get there soon enough. And NASDAQ listing? Yeah, good luck with that.

It's not? So they got BLA approval from FDA? Last I heard they wanted a type A meeting with FDA and as of last CC, there was no update.

For Covid, they announce great results in M/M trial. What does the market think of this news? We've gone from 5 to 3.50 in a couple of days. No one cares about what Cytodyn "said" they had. They want EUA. Anything other than that, SP falls. Most likely to 1.

Bye Bye NASDAQ.

You misspelled Chief Executive Officer.

TD Am says it is down 10.31%, not 9%

Guess they can't short it tomorrow... ?

Yes because they won't replace NP as CEO. At least hire a COO to help get things done. NP is too concerned with SP and defending PRs. Forget that, where are we with the Type A meeting?

NASDAQ never sent a comment letter. We expected such a letter over two weeks ago. It didn't come, fine... have you follow-up up with them?

Stop worrying about the share price. He needs help getting things done.

This looks good but what difference does it make? His press releases are supposed to be sent to... the press. Posting it on the website does nothing as no one sees it except for people like us. Sure, Yahoo.com will copy/paste it on their website. A few other websites will do the same.

Dr. Yo and/or Dr. Been will interview someone... again. NP said the 'media' was waiting for trial results. Why is there no mainstream media interviewing Dr. Patterson or Dr. Jay? BP went on Dr. Yo again. That's old news and no one outside of CYDY supporters cares to watch it.

Is NP going to do another proactive video? Please no.

The NEWS2 results were awesome. Where is the coverage? Why is Dr. Patterson or one of the other doctors not on CNN, Fox, CNBC... somewhere other than Dr. Yo (the RantesnotPanties guy :eye roll:).

If the news is that good then why the silence from anyone who can make a difference? The market doesn't care about Dr. Yo or Dr. Been. It certainly doesn't care about press releases from Nader P. Every one he submits causes a 10% drop in stock price.

Looks like investors are starting to doubt what is released by NP. It's unfortunate. Numbers may be good but it seems if they actually were, the mainstream press would be all over it. Any other company says they have good trial results and it's on Fox, CNN and the evening news.

Our numbers seem better than the SOC but no one cares or believes it. Why is that?

NP should step down and be on the BOD and someone else needs to take the helm to help this drug get to market. I don't believe he'll be able to manage that.

You would think it would fly through, but we're talking about a small biotech company that has no lobbying support or big dollars like Gilead.

Remdesivir was approved with mediocre results because of politics and lots of money.

If GILD would have bought Leronlimab for Covid treatment, it would have been approved already.

I know this. I'm just saying they didn't meet primary and this is why the stock price has gone down. That is all.

I totally agree. I'm just saying that they did not meet the primary endpoint. It doesn't mean the trial is a failure. In fact the secondary endpoint they had excellent results.

I see them moving into phase 3 trial. Not getting FDA approval for M/M right now. Maybe after phase 3.

If they don't meet primary endpoint in phase 3, it's game over for Covid indication. Time to move on to HIV approval.

It doesn't make a difference. I know he explained it. It didn't work and the market shows it. He explains a lot of things. He has to because he conveniently leaves them out of PRs.

But he refuses to write sentences in PRs that actually meet the criteria of endpoints. Oh wait... he does write comments WHEN THEY DO MEET THE ACTUAL ENDPOINT. He did in this PR on NEWS2, secondary endpoint. So he's doing this on purpose. If the endpoint was met, it would be highlighted in the PR. Period.

Don't you see? No way he could have made the same mistake twice (he did this on the last PR as well and that is why he had to EXPLAIN it).

Yes, the day 3 is important but NO ONE Cares because day 3 is not the primary endpoint. Maybe they got worse in day 7 or 8, who knows? Either way, it didn't meet the primary endpoint.

He should have made the primary endpoint Day 3. If he did, we'd all be celebrating today as the SP goes up. But they made it day 14.

Did not meet primary endpoint. If they did then NP would have certainly mentioned it in the PR. Instead, he said showed improvement in day 3. The primary endpoint was day 14, but nothing was said. He made the same error in the last PR. So it's most likely that they did not meet that endpoint or else he would have certainly mentioned it.

He did, on the other hand, mention day 14 for the NEWs secondary endpoint. Him omitting anything on the primary endpoint (day 14) shows that they did not meet the primary endpoint. Period.

So now the focus is on the good news of the secondary endpoint. The p scores for that endpoint were excellent.

It's okay if they don't meet the primary endpoint for phase 2 trials as they are not pass/fail. But you need to have, probably multiple secondary endpoint good results.

This is why the stock price isn't excited about this morning's news. They will probably enter phase 3 for M/M and they have to get the primary endpoint met or it's over.

Expect a hit piece from AF this afternoon. And the subsequent price fall.

Probably just the Russian announcement that they have a successful vaccine. You know, because... Russian wouldn't lie or fudge numbers.

But, investors are emotional and irrational.

I'm not sure he does know better. He means well and the note on improvements in day 3 was noteworthy. And it doesn't mean that those patients got sicker in day 5 or 6.

It just means they showed improvement in day 3, which is earlier than Dr. Jay L was expecting. That's why it was mentioned in the first place.

He didn't talk about day 14 because that will be included in the full report due in "10 days or so", per NP.

He needs to stop giving updates except for those updates that actually impact specific endpoints.

So can NP answer this?

This is essentially the only new beef with the call and NP:

So did NP mean that patients at the 14 day mark did not show improved symptoms, or that those that had improved at day 3 were all now back sick at day 14? AF is suggesting because he didn't say anything about day 14, then the trial failed. Quite a leap there, BUT, should NP come out and explain why his comments did not match up with the actual endpoint (So what's happening at 14 days, no one cares about 3 days as that is not the endpoint.




Again, why would NP not tailor his comments to match the actual endpoint? This only gives fuel to hit piece writers like AF.



So this is basically his only ammunition for the article. If NP used terms like "statistically significant after 3 days", it wouldn't be used against him. But why didn't NP talk about day 14?


Everything else in the hit piece is just more BS from the past.

So is Nader hiding something or is he just not capable of talking to the actual endpoints?

If this is uplisted and Robinhooders are able to sniff it, it'll shoot to 40+. They don't need to know anything about the drug or the company. Just news that it's getting approval and the fact that they can now see it on the NAZ.

Shorts don't need to attack at this point. The daily haircut this stock is taking is due to silence and investors being uneasy with the company. They know the CEO's mo and expect nothing much other than the regular optimistic "likely next week" promises of NP.

The shorts will attack tomorrow morning with a hit piece like the last one "Where are the promised results, NP is a pumper", so on and so forth.

I expect the SP to drop below 3. Wouldn't mind it at all actually IF the results are not released tomorrow and the price falls. I've trimmed some of my position this week and if/when it falls below 4, I'll be happy to build the position back up until real news comes out.

If the news is bad, I'm selling but will keep 1000 or so shares to set my sights on the HIV BLA and beyond. Covid is but one indication. It's not the whole story of Leronlimab. If the covid window is closed, the SP will be back to between 1 and 2 bucks. I'll be happy to buy there.

On the other hand, if the news is good/great, I'll buy back to my position and will be happy watching others do the same.

All IMO and best of luck to Longs.

Is this not an opportunity for Cytodyn to work its way into someone's radar?

Big Pharm declines Trump's offer for meeting on drug prices

Someone should get on the bat phone and say "we'll talk to you!"

Author called Leronlimab a vaccine candidate.

Welcome to the life of a biotech stock stuck out in OTC land where unscrupulous shorts and paid shills can write these hit pieces. Get uplisted to the NAZ and it'll open up channels to new investors.

As for media coverage, there is no mainstream media coverage for LL. A note here and there, a mention. We have youtube podcasts, paid proactive interviews, youtube channels like Yo and Been.

NP released a PR giving good safety numbers in the M/M trial.

Mainstream media: *crickets*

Big money talks. Remdesivir gets all the national headlines, no one cares about its side effects.

No national mention of Leronlimab after safety numbers. Stock loses .60 on the news.

We say "well, wait until the data is released." Yes, I'm waiting too. I fear that even if the data looks good, all we'll hear is *crickets* from mainstream media. Regardless of data, it will be spun around by paid short shills and a short attack will follow.

It's just the way it is. In my opinion, uplisting is paramount. Every bit of news that is released seems to negatively affect the SP.

#notselling but the lack of national exposure is concerning. All of the big picture posts are great to read and I love the optimism, but we need to be realistic. Breaking into big pharma is a very long shot. I'd be happy with a buy out at this point.

That said, I'm still hopeful of great things. Just trying to be real.

Yeah I know. Still, we can't seem to even get in proper contact with Mexico for a trial with a drug that has shown no adverse side effects. Why is that? I don' tknow.

There was supposedly a trial being set up for leronlimab along with remdesivir. But never materialized. Instead there's this other trial with neither leronlimab nor remdesivir. Anyone's guess.

Maraviroc, another CCR5 antagonist, is being used in a phase 2 trial in Mexico.

Link to ClinicalTrials

Maybe this is a reason why Mexico "lost" NP's email about a trial.

Did he say when DSMC is going to look at Severe/Critical trial? Didn't see that in notes posted, unless I missed it.

Excellent write-up. Thanks

I hope you're right.

If the drug can perform as they're predicting and they can successfully relay the data to powers that be (that seems to be tricky for them), they shouldn't need to raise money through this venture.

Hopefully the Gov't will provide funding for covid production.

Good points. I admire NP and love his passion but he just seems over his head sometimes. He trusts the scientists and is quick to give them the credit, but he could REALLY use some admin assistance. He's trying to play with the big boys now and if (when) the drug is approved and on the world stage... he's going to need some smart people in his inner circle.

Good luck to us all.

They need to hire this guy post haste...

A poster from Yahoo sent this.

"Dr. Kelly,

Good morning.

I’m sure you have more important things to focus on, but SOMETHING has to be done regarding the crafting of these PR’s. They are awful and this is not the first time the company has issued a critical PR that was confusing, lacked structure, deviated from conventional standards and negatively impacted the share price. I was once in charge of corporate communications for a small company that had a national footprint. Please consider a few changes in the future. Here are some pointers.

1. The PR should start with an encompassing headline; not details. The PR starts with “39% of Patients in Placebo Arm Had SAEs as Compared to Only 14% of Patients in Leronlimab Arm Had SAEs, Which Were Unrelated to Leronlimab.” It should have started with something more like “Leronlimab Demonstrates a 58.4% Reduction in Serious Adverse Events with ZERO SAE’s Attributed To Leronlimab.” That was your headline! That’s what captures the reader.

2. Numbers aren’t presented uniformly. Your bi-line states, “Leronlimab: 5 patients out of 56 (about 9%) reported serious adverse events, none were related to leronlimab”. But in the body of the PR it states, “Eleven (11) SAEs were reported in 6 patients (6/28; 21.4%) receiving placebo compared to eight (8) SAEs in 5 patients (5/56; 8.9%). In one place, the PR refers to “9%.” In another, the PR uses “8.9%” to refer to the same number. Since the two statements aren’t adjacent, the data is more confusing.

3. The author’s framework is completely lacking and had they incorporated better emphasis for the different data points, we would have had a much better communication. For instance, start with the more mild data points and then move towards the most critical cases or vice versa. But, at least have a framework. Start each section with an encompassing statement and then drill down on the data. Sell the sizzle, then present the steak. For instance:

a. “Adverse Events. Leronlimab showed a marked 32% reduction in Adverse Events. 14 out of 28 patients (50%) in the placebo group experienced adverse events whereas only 19 out of 56 (34%) patients in the Leronlimab arm had an adverse event. The between group difference was 32%. None of the adverse events were attributed to Leronlimab."

b. "Serious Adverse Events. Leronlimab showed a 58.4% reduction in Serious Adverse Events. 6 out of 28 patients (21.4%) in the placebo group experienced a serious adverse event whereas only 5 out of 56 (8.9%) patients in the Leronlimab arm had an adverse event. The between group difference was 58.4%. None of the adverse events were attributed to Leronlimab."

c. "Deaths. Only ONE death was reported in the entire trial. The death was not attributed to Leronlimab."

I’ve tried to communicate this to management previously. Apparently, it fell on deaf ears. I pray, the company starts applying a more scientific approach to the crafting of these PR’s. Your stock is down today but for one reason: the PR was poorly crafted. Once is a mistake. Twice is a problem. We shouldn’t need to follow up PR’s with multiple videos. That’s not the way a Fortune 500 company communicates. And yes, that’s the way management needs to start thinking about this. You are now on the global stage and these missteps can’t continue.

I’ve brought quite a few shareholders to the company and my position is x figures. I hope you are open to constructive criticism from those that have a vested interest in the company’s success.

Regards,"

I was reading it wrong at first. It's saying 11 events in 6 patients in the placebo arm. And 8 events (from 5 patients of the 56) in the LL arm. My apologies.

"Long haulers-cytokine storm to cytokine heavy rainfal"


What does this mean?

How many HIV subjects are in the trials? And were the HIV subjects actually tested for Covid?

It's interesting but if they weren't even tested then how do they know some of them don't have it and are just asymptomatic?

It's listed on NASDAQ. Exposure and the stock price reacts to news. CYDY, on the other hand, is mired in OTC land where no one cares or even hears about it. It doesn't matter if leronlimab is a better product.

Nothing short of positive trial results will help at this point. Up-listing to NASDAQ would expose CYDY to a world of additional investors. Need to do that.

No new listing for PR rep? shucks

PDUFA date. Everyone is expecting to hear something, one way or another, tomorrow.

Tomorrow may bring no news. Wouldn't surprise me if the FDA extended the PDUFA date. It's the allotted time for them to review, not necessarily for them to reply with a decision.

And when the day comes and goes with no news, the stock will take another dump and another hit article will say yet another missed promised deadline from NP.

He said he expects this news. Those listening translates that to he predicts it, opening the door for more fodder for shorts.

He just needs to stop talking until results can be released.