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***OFFICIAL CYDY/Leronlimab Thread***


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1 hour ago, chet said:

Letter from Jay Lalezari to Janice Woodcock:

 

I kinda blew this off because I figured dr Jay was on the board or whatever. He’s not? Is he considered a doctor of some stature? 

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3 minutes ago, BassNBrew said:

But we can still sell the $100 million plus of LL sitting in the warehouse for one of the other 40 indications before it expires amirite?

Love when the yahoo board says they’re holding for NASH. Cracks me up. 

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3 minutes ago, Capella said:

I kinda blew this off because I figured dr Jay was on the board or whatever. He’s not? Is he considered a doctor of some stature? 

He has worked on a large number of FDA trials and is quite well known.  He has no equity stake.

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18 minutes ago, chet said:

He has worked on a large number of FDA trials and is quite well known.  He has no equity stake.

Well that’s probably the best news in a couple of weeks then, even if it doesn’t get anywhere. 

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1 minute ago, Capella said:

Well that’s probably the best news in a couple of weeks then, even if it doesn’t get anywhere. 

I think there's a growing level of support to get CYDY an EUA.  There are some thorny ethical issues around this situation too.  For example, apparently if the FDA approves CD16 they would have to stop the OLE and eIND--if they are in possession of statistical proof that the drug is effective and even perhaps believe it works, how can they limit the administration of the drug to only those who are in CD16?  Also, if they grant a conditional EUA based on the outcome of CD16, who would sign up for the trial instead of getting it under the EUA.  

 

From a thread on Reddit:

She (Rachel Maddow) had Fauci on her show recently and was trying to get him to explain his reluctance in supporting therapeutics. At the end he basically came out and said he wanted a pill like they used in HIV. Nothing else was practical in his mind. She did get him to acknowledge there was a subQ option.

 

If the above is true, Fauci should be replaced.  It's criminal IMO.

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6 minutes ago, chet said:

I think there's a growing level of support to get CYDY an EUA.  There are some thorny ethical issues around this situation too.  For example, apparently if the FDA approves CD16 they would have to stop the OLE and eIND--if they are in possession of statistical proof that the drug is effective and even perhaps believe it works, how can they limit the administration of the drug to only those who are in CD16?  Also, if they grant a conditional EUA based on the outcome of CD16, who would sign up for the trial instead of getting it under the EUA.  

 

From a thread on Reddit:

She (Rachel Maddow) had Fauci on her show recently and was trying to get him to explain his reluctance in supporting therapeutics. At the end he basically came out and said he wanted a pill like they used in HIV. Nothing else was practical in his mind. She did get him to acknowledge there was a subQ option.

 

If the above is true, Fauci should be replaced.  It's criminal IMO.

They got statistical proof that it wasn't more effective. 

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2 minutes ago, Charlie Harper said:

They got statistical proof that it wasn't more effective. 

Look, I am not going to debate this any further.  Read Lalezari's letter if you'd like to come up to speed--he is an informed and objective third party whose only vested interest is saving lives.  Or don't.  I don't care.  

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8 minutes ago, chet said:

Look, I am not going to debate this any further.  Read Lalezari's letter if you'd like to come up to speed--he is an informed and objective third party whose only vested interest is saving lives.  Or don't.  I don't care.  

Wasn't he the previous Chief Medical Officer? I wouldn't describe him as a neutral 3rd party.

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8 minutes ago, chet said:

Look, I am not going to debate this any further.  Read Lalezari's letter if you'd like to come up to speed--he is an informed and objective third party whose only vested interest is saving lives.  Or don't.  I don't care.  

It's a good letter.  The problem is that the math doesn't add up.  I don't care if Hippocrates comes back from the dead and writes a letter.  Until someone explains why LL performed worse than the placebo in some subsets I think EUA isn't likely.

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1 minute ago, Charlie Harper said:

Wasn't he the previous Chief Medical Officer? I wouldn't describe him as a neutral 3rd party.

He previously was an advisor to the company.  The rumor mill is that Nader fired him but I have no proof of that.  What I can say is that this is the first time in months that he has said anything publicly about the drug.  

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Just now, chet said:

He previously was an advisor to the company.  The rumor mill is that Nader fired him but I have no proof of that.  What I can say is that this is the first time in months that he has said anything publicly about the drug.  

https://www.cytodyn.com/newsroom/press-releases/detail/394/cytodyn-appoints-jacob-lalezari-m-d-as-interim-chief

Incorrect per Cytodyn website.

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5 minutes ago, BassNBrew said:

That's from a year ago and since then, Scott Kelly was appointed CMO.  As I said, I haven't heard anything from him for months and he owns no equity in CYDY.  Is it possible he's still being paid as a consultant?  Sure.  However, I don't think a paid consultant would write such a letter if he didn't believe it.

Also, please point me to the subsets where the drug did worse than placebo.

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37 minutes ago, chet said:

That's from a year ago and since then, Scott Kelly was appointed CMO.  As I said, I haven't heard anything from him for months and he owns no equity in CYDY.  Is it possible he's still being paid as a consultant?  Sure.  However, I don't think a paid consultant would write such a letter if he didn't believe it.

Also, please point me to the subsets where the drug did worse than placebo.

Yeah...I wasn't implying he was the current CMO, just that he was more than a consultant.  Just trying to be accurate.  I think you could argue that given he's departed and has no financial stake (per his words), that this is actually a good endorsement.  More often than not a former employee isn't going to go out of his way for their previous company.  Either he's a good guy trying to do the right thing or he's trying to help out his former co-workers.  Both sides have merit but we don't have enough information to figure out the motive IMO.

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19 minutes ago, unckeyherb said:

I'd be  interesting to see this as well as I was not aware of this.

It's in one of the Seeking Alpha articles posted.  Basically the trail was a push.  LL did so well in one arm they broke out that it left another arm where the placebo was superior.  There just aren't enough data points to sort this out.  Also there's a huge issue which @chet mentioned where if they start a new study then Eind is halted and we get less data.  For CYDY's sake I hope the FDA is working with them on this.

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18 minutes ago, BassNBrew said:

It's in one of the Seeking Alpha articles posted.  Basically the trail was a push.  LL did so well in one arm they broke out that it left another arm where the placebo was superior.  There just aren't enough data points to sort this out.  Also there's a huge issue which @chet mentioned where if they start a new study then Eind is halted and we get less data.  For CYDY's sake I hope the FDA is working with them on this.

Do you mean the articles written by Paulo Santos who discloses he's short the stock and also recommended shorting AMZN at $100.

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54 minutes ago, chet said:

Do you mean the articles written by Paulo Santos who discloses he's short the stock and also recommended shorting AMZN at $100.

Yup.  Just because you are short doesn't mean anything you say is invalid.  If we use that principal, then you being long would make anything you say good about the company invalid.  Just because you were wrong about cydy being a good value in the 4s a month or so ago doesn't mean that your UUUU recommendation at $3.xx should be ignored.

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29 minutes ago, BassNBrew said:

Yup.  Just because you are short doesn't mean anything you say is invalid.  If we use that principal, then you being long would make anything you say good about the company invalid.  Just because you were wrong about cydy being a good value in the 4s a month or so ago doesn't mean that your UUUU recommendation at $3.xx should be ignored.

I agree with you in general.  However, there are a bunch of guys (now called the #shortmafia) who lie and distort the truth primarily for profit.  It's disgusting.  

Here's a new Insider Financial "story" tying Paolo to Adam Feuerstein.  I don't believe anything Adam Feuerstein writes, and now by extension, anything that Paulo writes.  

Both are bad people who are worsening the misery the world is feeling from COVID.  They will burn in hell if there is any justice.

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One distortion that Feuerstein constantly says is that a p-value that is not below 0.05 shows that the drug statistically is no different than saline.  This is simply not true.  A p-value is a value that shows the percentage likelihood that the results from your trial were random.  The FDA has chosen 0.05 to be the line in the sand.  So a p-value of .07 means that there is a 7% chance your results were from luck and a 93% chance that whatever is being measured is due to the drug.  So still overwhelmingly likely that there is benefit to the drug but not enough to get over the FDA's line--maybe if the trial were a little bigger (powering the trial), the 0.05 threshold would have been met.

I believe this is why Woodcock said she was going to look at the results instead of just the p-value.

 

Edited by chet
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If NP thought there was any chance of an EUA he would have already applied for it.  This trial of 140 is the best chance for Cytodyn but we won't know if it was effective for at least another 4 months if not longer.

I think the stock will be in the $1.50 range before it gets to the $3 range again

 

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8 minutes ago, Dwayne Hoover said:

If NP thought there was any chance of an EUA he would have already applied for it.  This trial of 140 is the best chance for Cytodyn but we won't know if it was effective for at least another 4 months if not longer.

I think the stock will be in the $1.50 range before it gets to the $3 range again

 

I think this also, but it is showing a lot of resilience.

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18 minutes ago, kevzilla said:

Most importantly, he's run over 100 clinical trials. Perhaps he can design one that works!

Actually this guy got promoted for failing so far.  Was formerly the VP of Clinical Development at Cytodyn.

Par for the course

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6 minutes ago, Dwayne Hoover said:

Actually this guy got promoted for failing so far.  Was formerly the VP of Clinical Development at Cytodyn.

Par for the course

I noticed that as well, this was a promotion, not an external hire and considering how few employees there are he’s not likely replacing anyone. 

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6 hours ago, Chaz McNulty said:

With a company with only 20 people, it must be a lonely feeling if you're the only one that isn't an officer, VP, director, etc. of the company.

VPs get to use teh indoors plumbing, everyone else heads back to teh woods.

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brucep@brucep13

·

1h

Just sent a letter as well!!

Quote Tweet

Kevin G. O'Neill@kgo81

· Mar 15

Replying to @brucep13

Dr Jay Lalezari has just written a letter to @DrWoodcockFDA at the FDA about the strategic importance of #Leronlimab CD12 results and posted it over on his Quest Clinical Research website. Here’s a link to the pdf: …https://951217f1-eeef-4b64-88e6-a52aefaa6edc.filesusr.com/ugd/2a39c2_343d9e65467049d08898c8107bb761c5.pdf

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Management will update stockholders on the Company’s recent COVID-19 related filings for Conditional EUA with the FDA in U.S., Interim Order in Canada, and accelerated rolling review in U.K., as well as potential similar filings in Brazil and the Philippines. Management will also provide updates on its active trials in COVID-19, NASH and Cancer, along with expected timelines for BLA submissions for HIV in U.S., Canada and U.K.

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1 hour ago, Getzlaf15 said:

Management will update stockholders on the Company’s recent COVID-19 related filings for Conditional EUA with the FDA in U.S., Interim Order in Canada, and accelerated rolling review in U.K., as well as potential similar filings in Brazil and the Philippines. Management will also provide updates on its active trials in COVID-19, NASH and Cancer, along with expected timelines for BLA submissions for HIV in U.S., Canada and U.K.

Fingers crossed.

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5 minutes ago, Capella said:

I thought last we heard, they haven’t even filed for that? Is that bad info or is this a new development?

I don't think so.  This is the first I've heard of an EUA application.  Now the pressure is on the FDA--the application implies there was some sort of discussion with the FDA where they either encouraged CYDY to apply or said something like it can't hurt.  I believe there have been other instances where the FDA has actually said, we don't think you should apply for approval.

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4 minutes ago, chet said:

I don't think so.  This is the first I've heard of an EUA application.  Now the pressure is on the FDA--the application implies there was some sort of discussion with the FDA where they either encouraged CYDY to apply or said something like it can't hurt.  I believe there have been other instances where the FDA has actually said, we don't think you should apply for approval.

I guess until I see the proof I won’t believe it. Guy has lied/manipulated words the entire time. I’m hopeful though. 

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