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***OFFICIAL CYDY/Leronlimab Thread*** (3 Viewers)

chet said:
Letter from Lalezari et al.
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I honestly think that this whole letter was just a vehicle so they can soft sell this.  

In the meantime, the FDA has refused to approve CytoDyn’s request for an Emergency Use Authorization (EUA).
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Nevermind.  I just realized lalezari has no association with Cytodyn.  Although, I'm not sure how he would know if the EUA has been refused.

 
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Chaz McNulty said:
Any idea what this means?  Little mistake or big ####-up?
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HIV is why many here got into this in the first place.  Covid is/was a side chick.  The rolling review for the BLA seems like a pretty important aspect for the growth and income potential for this company.  That being said, letting it expire, to me, is a exercise in incompetence.  

Its possible that this is standard practice and they can just re-file, but that feels counter-intuitive; especially considering that this is not some BP company.  You'd think they want to appear on the ball as much as possible.

ETA: this is from a poster on Ihub and seems like it is possible that this is likely:

Rahman let it expire and maybe it was why he was let go, but it does not make any difference.

Rolling Review allows a company to submit their BLA in modules but the FDA does not look at each module and give it a thumbs up or down. They don't look at the BLA until it is fully submitted.

So it expires, they resubmit the whole thing when they have all the requisite data.

Until 100% of the BLA is submitted, then it's the same as nothing submitted.

Armchair quarterbacks are up in arms because of a nothing burger.

If you look at the presentation there is information there that is not palatable, in my opinion it was put out to inform shareholders as a requirement for something. This is serving as a kind of a CYA for the company so that a coming event or development is not invalidated by a technicality that shareholders were not fully informed.
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Not sure what the bolded means.  Buy out coming?

 
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unckeyherb said:
HIV is why many here got into this in the first place.  Covid is/was a side chick.  The rolling review for the BLA seems like a pretty important aspect for the growth and income potential for this company.  That being said, letting it expire, to me, is a exercise in incompetence.  

Its possible that this is standard practice and they can just re-file, but that feels counter-intuitive; especially considering that this is not some BP company.  You'd think they want to appear on the ball as much as possible.
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Agreed.  This along with the Mahboob firing (leaving?) smells rotten.  

 
unckeyherb said:
HIV is why many here got into this in the first place.  Covid is/was a side chick.  The rolling review for the BLA seems like a pretty important aspect for the growth and income potential for this company.  That being said, letting it expire, to me, is a exercise in incompetence.  

Its possible that this is standard practice and they can just re-file, but that feels counter-intuitive; especially considering that this is not some BP company.  You'd think they want to appear on the ball as much as possible.

ETA: this is from a poster on Ihub and seems like it is possible that this is likely:

Not sure what the bolded means.  Buy out coming?
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🙏🙏🙏🙏🙏🙏🙏🙏🙏🙏🙏🙏🙏🙏🙏

 
unckeyherb said:
Well, BLA was in his bailiwick, so maybe he is the one that dropped the ball and it got him canned? 
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That’s the theory I’ve seen too.  And with almost any other leadership I’d buy it, but with NP you just never know.  I’d put my money on him ####### it up if I had to place a bet.  

 
NP: Come work with us and help us take this well-oiled machine over the finish line

Mahboob: OK, let's do it.

[Mahbood arrives to work, looks through dumpster fire that are existing files, breaks into hives)

Mahboob: What is this crap? What the hell have you people been doing?

NP: I don't like you anymore. You're fired.

 
chet said:
I highly doubt it was Mahboob's incompetence that got him fired.
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This is where I lean.

I don't think we are being given an honest assessment of a realistic timeline for the BLA, what the hurdles are and especially if they can be overcome without another trial.

NP said we would get an update two weeks ago on the BLA, so far crickets. Big surprise.

If I was an investor, I'd be pressing for an answer but most of the boards don't seem to see this as a major issue, when it absolutely is.

I'll come back in after the bad news gets delivered

 
Chaz McNulty said:
Nice.  If I'm reading this right, he gets them at $1.35.

I wonder if he has to hold them for a certain amount of time, or if he can just flip them?
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Yeah I wonder if he has to report when he does flip them.  Timing of that would be interesting for sure.  

 
Sorry if Honda as I haven't been on this forum much lately--but I got a letter about a class action lawsuit against CYDY yesterday.  In brutal honesty--I'm not really experienced or good at figuring out legal stuff- so has anybody who has gotten the same letter mind giving me the cliff notes version of whats going on?  Thanks in advance. 

 
Chaz McNulty said:
Was there discussion of LL in this?
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At 4:05:38 Dr Randy starts talking and you can understand him, which is a big plus.  Still listening but he's campaigning to stock leronlimab because they are getting requests for it and its not convenient on one off basis because it takes about 5 weeks for transport

 
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Chaz McNulty said:
Was there discussion of LL in this?
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from my friend:

Check out Dr. Nicholas at 1:03 mark and then listen again around 4:02…the FDA basically says that Philippine hospitals can now stock up to 100 patients per hospital, but not distribute until CSP is approved.

There are 110 hospitals in Philippines…that could be 40K doses for 100 patients at 4 doses per patient

 
Dwayne Hoover said:
At 4:05:38 Dr Randy starts talking and you can understand him, which is a big plus.  Still listening but he's campaigning to stock leronlimab because they are getting requests for it and its not convenient on one off basis because it takes about 5 weeks for transport
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Sounds like they just want the hospitals to have some of it in case they are granted the EIND.  Currently it takes a week to transport it and a patient died while waiting.  They just told the guy that the hospitals can apply for it without giving the patient name, and then when someone requests the EIND they will have it locally.

 
Chaz McNulty said:
Sounds like they just want the hospitals to have some of it in case they are granted the EIND.  Currently it takes a week to transport it and a patient died while waiting.  They just told the guy that the hospitals can apply for it without giving the patient name, and then when someone requests the EIND they will have it locally.
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Unfortunately for stockholders, Pourhassen included free shipping for any orders placed before May 1.

 
Dwayne Hoover said:
At 4:05:38 Dr Randy starts talking and you can understand him, which is a big plus.  Still listening but he's campaigning to stock leronlimab because they are getting requests for it and its not convenient on one off basis because it takes about 5 weeks for transport
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5 weeks?? Are they walking it there?

 
I can't tell if there is any teeth to this or not.  I know Dr Randy is an advocate for this drug but is the FDA Phillipines going to be in any more of a hurry to approve than the U.S is?

Results from those 28 patients they dosed is gonna be telling

I don't want to miss a run here but risky entry point

 
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Dwayne Hoover said:
I can't tell if there is any teeth to this or not.  I know Dr Randy is an advocate for this drug but is the FDA Phillipines going to be in any more of a hurry to approve than the U.S is?

Results from those 28 patients they dosed is gonna be telling

I don't want to miss a run here but risky entry point
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They have a deal with Chiral to distribute 200,000 vials.  If this first step leads to THAT happening then I'd say its got some teeth.  At $1200 a dose you're looking at $240 million.  Getting some income would obviously be homerun.

 
Capella said:
5 weeks?? Are they walking it there?
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If Bezos was doing his job they would be prime members.

unckeyherb said:
They have a deal with Chiral to distribute 200,000 vials.  If this first step leads to THAT happening then I'd say its got some teeth.  At $1200 a dose you're looking at $240 million.  Getting some income would obviously be homerun.
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:lol:   I thought you said China at first pass, not Chiral.  Those 6 new cases a day would be a market Pourhousan would be all over.

 
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