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***OFFICIAL CYDY/Leronlimab Thread***


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53 minutes ago, unckeyherb said:

https://d1io3yog0oux5.cloudfront.net/_4f7927b69d19b93bb97ca111e4ba9d56/cytodyn/db/193/2912/pdf/CytoDyn+-+Investor+Presentation_Updated+4-20-2021+(final).pdf
 

BLA Rolling Review has expired, according to this presentation released yesterday.  That seems like a misstep.  

Any idea what this means?  Little mistake or big ####-up?

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Yes, go ahead FC42

I closed.  Cydy operation mountain house completed.

Told my wife I was about to buy some more and she said that’s what I’ll get to keep in the divorce proceedings 😂😂😭😭😤

42 minutes ago, chet said:

I honestly think that this whole letter was just a vehicle so they can soft sell this.  

Quote

In the meantime, the FDA has refused to approve CytoDyn’s request for an Emergency Use Authorization (EUA).

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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23 minutes ago, Chaz McNulty said:

Any idea what this means?  Little mistake or big ####-up?

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:

Quote

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.


Not sure what the bolded means.  Buy out coming?

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7 minutes ago, 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.

Agreed.  This along with the Mahboob firing (leaving?) smells rotten.  

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11 minutes ago, 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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29 minutes ago, dkp993 said:

Agreed.  This along with the Mahboob firing (leaving?) smells rotten.  

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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15 minutes ago, unckeyherb said:

Well, BLA was in his bailiwick, so maybe he is the one that dropped the ball and it got him canned? 

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.  

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25 minutes ago, unckeyherb said:

Well, BLA was in his bailiwick, so maybe he is the one that dropped the ball and it got him canned? 

I highly doubt it was Mahboob's incompetence that got him fired.

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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.

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29 minutes ago, McBokonon said:

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.

Reminds me of when Kramer was fired from a job when he didn't even work there.   

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1 hour ago, chet said:

I highly doubt it was Mahboob's incompetence that got him fired.

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

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41 minutes ago, Capella said:

Please somebody post the lame-### excuse from that 4/21 guy whenever he gets around to making it. Thx. 

He’s ghosted today there. But this 8k was just filled.  Can someone smarter then me decode...

https://ih.advfn.com/stock-market/USOTC/cytodyn-qb-CYDY/stock-news/84884287/current-report-filing-8-k

 

* @unckeyherb types just a bit quicker then me I guess.  Lol

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25 minutes ago, dkp993 said:

He’s ghosted today there. But this 8k was just filled.  Can someone smarter then me decode...

https://ih.advfn.com/stock-market/USOTC/cytodyn-qb-CYDY/stock-news/84884287/current-report-filing-8-k

 

* @unckeyherb types just a bit quicker then me I guess.  Lol

I quickly scanned it.  Doesn't appear to be any new news, but I probably missed something.  Is this the big 4/21 event?  Boo.

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Just now, Capella said:

They don’t have approval to sell there though. So who cares for now. 

Right.  Until there is income, no one cares.  This is at least a step in the right direction and not a step backwards.

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1 hour ago, Capella said:

They don’t have approval to sell there though. So who cares for now. 

I think this is incorrect.  They have approval to sell 2 does in the next year in the Philippines.

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4 minutes ago, dkp993 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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3 hours ago, Capella said:

Please somebody post the lame-### excuse from that 4/21 guy whenever he gets around to making it. Thx. 

Dude is getting killed over there. Still a no-show but lots of people calling him out.  

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36 minutes ago, 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?

Yeah I wonder if he has to report when he does flip them.  Timing of that would be interesting for sure.  

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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. 

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10 minutes ago, Chaz McNulty said:

Was there discussion of LL in this?

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

Edited by Dwayne Hoover
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16 minutes ago, Chaz McNulty said:

Was there discussion of LL in this?

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

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6 minutes ago, 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

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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2 minutes ago, 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.

Unfortunately for stockholders, Pourhassen included free shipping for any orders placed before May 1.

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13 minutes ago, 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

5 weeks?? Are they walking it there?

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23 minutes ago, BassNBrew said:

What part of the 4 hour video?

You really need to dive into this video to glean all the relevant information.  I suggest you watch it in its entirety and then report back here at around noon PST to update us.

 

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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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5 hours ago, 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

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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12 hours ago, Capella said:

5 weeks?? Are they walking it there?

If Bezos was doing his job they would be prime members.

6 hours ago, 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.

: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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