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***OFFICIAL CYDY/Leronlimab Thread*** (2 Viewers)

This is a time where if you could trust the CEO, you might feel fine.

NP hasn't done much to earn trust and he very well could be playing games with vague PRs again here.

This has been quite the ride for me, up and down with it.  I sold a 1/3 of what I have this morning.  Considering more just to stave off a slow drip over the next few weeks.

Can always buy back if it goes a lot lower, I'm sure there will be time.

 
You guys spent the last two weeks talking me into this based on no news because they were working with the FDA and now you are talking me out of it.  

 
BassNBrew said:
You guys spent the last two weeks talking me into this based on no news because they were working with the FDA and now you are talking me out of it.  
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Nobody likes a vague press release from NP, his record speaks for itself.

The red flag is at least getting raised when he says the data is unblinded but is not gushing about the primary endpoint being met.

I'll be the first to say IDK though, there are plenty of possibilities going on behind the scenes and good news could still be coming, its just NP's action that makes me cautious right now.

 
BassNBrew said:
You guys spent the last two weeks talking me into this based on no news because they were working with the FDA and now you are talking me out of it.  
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The truth is I don’t know — I didn’t like having as much risk as I did after reading that PR this morning so I am going 50/50 with this and Hgen. 

 
This is another fail like CD10 for which the company has never released data. CD12 is clearly a fail and they are not releasing data here either. If data were positive NP would be letting you know in big bold letters.

Just another manipulation through vague wording that makes no sense. Stall tactic why NP tries to buy time to come up with something to keep people in. I would guess that long haulers is going to be that next big talking point.

It still grinds me I fell for this side show carnival pitch. I remember the video conference that had NP, Patterson and Alazari all present and saying things that God was smiling down on us because of what LL can do.

Unless the SEC should ever decide to step in I can still see NP luring in people. And there probably is still money to be made playing pump and dump. But it is not a stock to be in if you are a true long.

 
This PR pretty much confirms it didn't hit. 

I think NP doesn't have the pull to get this through without statistical significance. 

I don't know if there's precedent set, but CYDY might get caught in purgatory where it's kept open as an eIND just as a method of last resort. 

I think I'll cut my shares again.

 
Moonlight said:
This is another fail like CD10 for which the company has never released data. CD12 is clearly a fail and they are not releasing data here either. If data were positive NP would be letting you know in big bold letters.

Just another manipulation through vague wording that makes no sense. Stall tactic why NP tries to buy time to come up with something to keep people in. I would guess that long haulers is going to be that next big talking point.

It still grinds me I fell for this side show carnival pitch. I remember the video conference that had NP, Patterson and Alazari all present and saying things that God was smiling down on us because of what LL can do.

Unless the SEC should ever decide to step in I can still see NP luring in people. And there probably is still money to be made playing pump and dump. But it is not a stock to be in if you are a true long.
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I know you are really jaded but it's not clearly a fail if the FDA has not pulled the OLE or eIND.

Trust me, I'm juggling both arguments in my mind here but I don't think anything is clear.

I feel like they are probably close, perhaps more data comes in from the OLE patients that puts them over the edge. I really don't believe it's game over yet or we would know that.

 
Moonlight said:
This is another fail like CD10 for which the company has never released data. CD12 is clearly a fail and they are not releasing data here either. If data were positive NP would be letting you know in big bold letters.

Just another manipulation through vague wording that makes no sense. Stall tactic why NP tries to buy time to come up with something to keep people in. I would guess that long haulers is going to be that next big talking point.

It still grinds me I fell for this side show carnival pitch. I remember the video conference that had NP, Patterson and Alazari all present and saying things that God was smiling down on us because of what LL can do.

Unless the SEC should ever decide to step in I can still see NP luring in people. And there probably is still money to be made playing pump and dump. But it is not a stock to be in if you are a true long.
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Somebody on yahoo said the language about “in discussions with fda etc” was the same from a PR for cd10 back in September. 
 

"CytoDyn will also provide an update on the ongoing discussions with the FDA and the U.K. Medicines & Healthcare product Regulatory Agency (MHRA) for leronlimab as a treatment for COVID-19." - Sept 10

 
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I'm worn out on this ride, I will say that much.  

Put a lot of time into staying updated, most of that time is obviously just wasted time as nothing happens.

Then when you do get a PR, its murky and makes you question what you are doing here.

I dont trust NP but I still trust the Doctors that have been advocating it.   Its possible though, they just didn't design the most efficient trial to showcase its strengths and are now in purgatory again.

If its close, will the FDA trust Cytodyn enough to want to work with them?  That answer is a struggle for me, I don't know that they would... Cytodyn needs a partner here I think

 
Here's something I heard earlier today.  The ongoing FDA discussions could be CYDY asking for full approval instead of EUA because they showed the drugs works for mild/moderate in CD10.  A full approval would allow for off-label use whereas an EUA would not. The FDA does not have ongoing discussions with companies whose drugs fail.  Also telling is that OLE and EINDs continue.  Another point is that the data was unblinded earlier--we don't know exactly when.  He would have had to announce a bad trial if that were the case.  

All in all, it was supremely stupid to issue that PR but I've come to expect that. 

 
Dwayne Hoover said:
I'm worn out on this ride, I will say that much.  

Put a lot of time into staying updated, most of that time is obviously just wasted time as nothing happens.

Then when you do get a PR, its murky and makes you question what you are doing here.

I dont trust NP but I still trust the Doctors that have been advocating it.   Its possible though, they just didn't design the most efficient trial to showcase its strengths and are now in purgatory again.

If its close, will the FDA trust Cytodyn enough to want to work with them?  That answer is a struggle for me, I don't know that they would... Cytodyn needs a partner here I think
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Yea now that I’ve been out of it today I’m not sure I’m getting back in. Lot of lost time following this crap. We’ll see. I just don’t trust the company at all. 

 
chet said:
Here's something I heard earlier today.  The ongoing FDA discussions could be CYDY asking for full approval instead of EUA because they showed the drugs works for mild/moderate in CD10.  A full approval would allow for off-label use whereas an EUA would not. The FDA does not have ongoing discussions with companies whose drugs fail.  Also telling is that OLE and EINDs continue.  Another point is that the data was unblinded earlier--we don't know exactly when.  He would have had to announce a bad trial if that were the case.  

All in all, it was supremely stupid to issue that PR but I've come to expect that. 
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How do we know the fda is having conversations? Just because Nader put it in a PR? If the fda said no thanks they aren’t going to come out and announce it. 
 

We truly don’t even know if the OLE and EINDs are being used. We assume they are but as far as I know there isn’t any proof. 
 

I’m just tired of the deception and incompetence. 

 
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chet said:
.  

All in all, it was supremely stupid to issue that PR but I've come to expect that. 
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If its proving to be a warning sign, Im glad he did.

Current stock price doesnt matter to me, the end goal is all that matters.  That PR seems to be saying its a murky situation though, that's the current read I have and if it really is, then I need to sell more shares.

 
Capella said:
How do we know the fda is having conversations? Just because Nader put it in a PR? If the fda said no thanks they aren’t going to come out and announce it. 
 

We truly don’t even know if the OLE and EINDs are being used. We assume they are but as far as I know there isn’t any proof. 
 

I’m just tired of the deception and incompetence. 
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I talked to two people today who have been investors for years.  They both own several million shares and have met NP many times.  I said the only way the item about ongoing discussions with the FDA could be negative is if NP is lying about it.  Neither of them thinks highly of him but they both said there's no way he's stupid enough to lie about that.  Lie in a material way on an official PR?  I just don't think it's possible.

 
chet said:
I talked to two people today who have been investors for years.  They both own several million shares and have met NP many times.  I said the only way the item about ongoing discussions with the FDA could be negative is if NP is lying about it.  Neither of them thinks highly of him but they both said there's no way he's stupid enough to lie about that.  Lie in a material way on an official PR?  I just don't think it's possible.
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They are definitely having conversations, the big question is do they already know the data is borderline

 
chet said:
I talked to two people today who have been investors for years.  They both own several million shares and have met NP many times.  I said the only way the item about ongoing discussions with the FDA could be negative is if NP is lying about it.  Neither of them thinks highly of him but they both said there's no way he's stupid enough to lie about that.  Lie in a material way on an official PR?  I just don't think it's possible.
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Ok that’s true but maybe he’s not lying but just omitting truth. Yes we are in discussions but we haven’t heard from the fda for 3 weeks or whatever. 
 

What was the point of the PR? He absolutely HAD to know what that would do to the share price. 

 
Capella said:
Ok that’s true but maybe he’s not lying but just omitting truth. Yes we are in discussions but we haven’t heard from the fda for 3 weeks or whatever. 
 

What was the point of the PR? He absolutely HAD to know what that would do to the share price. 
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I've stopped trying to interpret what he does, and to a lesser extent Scott Kelly.  I will say that he probably thought it would help the stock but he has no experience in the stock market and isn't qualified to make those determinations.  

 
FDA recommendations to monoclonal antibody producers.

Given the serious concerns raised by the emergence of SARS-CoV-2 variants, FDA intends to leverage its emergency authorities under section 564 of the FD&C Act, when appropriate, to foster the development and availability of therapeutics for use during the current public health emergency. When scientifically supported, FDA will streamline the data necessary to support the development of monoclonal antibody products targeting SARS-CoV-2 and also expedite the review of these data.
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8.2 mil shares traded in the first 30 minutes. This type of whip saw action is usually a bottom.

Almost 3x the amount of shares traded in any 30-minute period in the last month.
 

 
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Getzlaf15 said:
8.2 mil shares traded in the first 30 minutes. This type of whip saw action is usually a bottom.

Almost 3x the amount of shares traded in any 30-minute period in the last month.
 
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I show 8.42MM shares traded for the day.  Are you saying only 220k shares have traded in the last 5.5 hours?  That can't be right.

 
chet said:
FDA recommendations to monoclonal antibody producers.

Given the serious concerns raised by the emergence of SARS-CoV-2 variants, FDA intends to leverage its emergency authorities under section 564 of the FD&C Act, when appropriate, to foster the development and availability of therapeutics for use during the current public health emergency. When scientifically supported, FDA will streamline the data necessary to support the development of monoclonal antibody products targeting SARS-CoV-2 and also expedite the review of these data.
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A whole lot of drugs ending in "...imab" in Fauci's presentation a few minutes ago.  One notable omission (actually two, for those of us also holding HGEN).

 
SFBayDuck said:
A whole lot of drugs ending in "...imab" in Fauci's presentation a few minutes ago.  One notable omission (actually two, for those of us also holding HGEN).
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Which ones did he mention and where are they in development compared to LL?

He probably mentioned Tocilizumab (approved).

 
chet said:
 Neither of them thinks highly of him but they both said there's no way he's stupid enough to lie about that.  Lie in a material way on an official PR?  I just don't think it's possible.
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Didn't he do as much about the Nasdaq uplist application?  Was that ever in an actual PR?

 
chet said:
Which ones did he mention and where are they in development compared to LL?

He probably mentioned Tocilizumab (approved).
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I actually didn't catch which ones he mentioned, just glanced up from my lunch and saw it on the screen.  But there were a handful.  Here's the part of the briefing where he talks about it, but while he keeps referencing "next slide" during the briefing, I can't find a version on YouTube that is actually showing the slides (which they did show on tv).

A quick google search and it looks like bamlanivimab and etesevimab (used together), casirivimab and imdevimab (used together) have EUA. 

 
Capella said:
Yea now that I’ve been out of it today I’m not sure I’m getting back in. Lot of lost time following this crap. We’ll see. I just don’t trust the company at all. 
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Who are you? Please return the keys to my Ifriend Capella

 
Dwayne Hoover said:
I know you are really jaded but it's not clearly a fail if the FDA has not pulled the OLE or eIND.

Trust me, I'm juggling both arguments in my mind here but I don't think anything is clear.

I feel like they are probably close, perhaps more data comes in from the OLE patients that puts them over the edge. I really don't believe it's game over yet or we would know that.
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I do not know a lot about OLE or eIND lets get that out. But my impression is that neither means a drug is getting FDA approval. A question to be asked is how many and which people have been using LL through OLE or eIND? 

 
Dwayne Hoover said:
I know you are really jaded but it's not clearly a fail if the FDA has not pulled the OLE or eIND.

Trust me, I'm juggling both arguments in my mind here but I don't think anything is clear.

I feel like they are probably close, perhaps more data comes in from the OLE patients that puts them over the edge. I really don't believe it's game over yet or we would know that.
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I get more jaded with each day. I mean the company was just successfully sued for unjust enrichment of mgt, the CFO is selling mucho shares just before data is supposed to be released, NP while claiming that he will obtain financing without dilution gets high interest financing that ends up in stock conversion and further dilution. Since I have been involved with CYDY I can not think of anything they have successfully accomplished.

What happened to the BLA for HIV? They again have not released why it was rejected or what needs to be fixed. 

Funny thing I would be scared to short the stock. It has such an ability of attracting new investors and raising SP through vague PRs and promotions hinting at new uses or markets in new countries.

And on the very odd chance it has something that works its getting passed by other companies able to design and complete trials that demonstrate efficacy.

There are just so many other choices out there that seem safer to me.

 
Moonlight said:
I get more jaded with each day. I mean the company was just successfully sued for unjust enrichment of mgt, the CFO is selling mucho shares just before data is supposed to be released, NP while claiming that he will obtain financing without dilution gets high interest financing that ends up in stock conversion and further dilution. Since I have been involved with CYDY I can not think of anything they have successfully accomplished.

What happened to the BLA for HIV? They again have not released why it was rejected or what needs to be fixed. 

Funny thing I would be scared to short the stock. It has such an ability of attracting new investors and raising SP through vague PRs and promotions hinting at new uses or markets in new countries.

And on the very odd chance it has something that works its getting passed by other companies able to design and complete trials that demonstrate efficacy.

There are just so many other choices out there that seem safer to me.
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HGEN is just as risky but for different reasons.  Both could get approved, one could get approved, neither could get approved.  I'm hedging my bet a little and just making sure I have some of both.

Nothing about HGEN's trials have been screaming success though. There has been multiple endpoint changes and changes to trial size.  Did they get it right in the end?  Its a guess.  The drug seems to have its own issues. At the end of the day, I'm far from convinced it's better than leronlimab and this is more important than the CEO IMO.

I like the connections though and the CEO does carry himself better (if you ever hear from him at all)

 
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