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***OFFICIAL CYDY/Leronlimab Thread***


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15 minutes ago, Capella said:

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

What are you talking about?  He said major news from the Philippines within 48 hours. That was only 10 days ago.  

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2 hours 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.

Is there such a thing as a Conditional EUA?  I thought an EUA was already a conditional approval.

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6 minutes ago, Gally said:

Whenever I see this thread title at a quick glance I always think it says the "Official CD Lamb" thread.  Then I wonder why it's in the FFA

J doesn't allow train wreck threads in the Shark Pool so all Cowboys discussion gets sent here.

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Optimistic view:

FDA encouraged conditional EUA for ethical reasons.  Forcing CYDY to conduct CD16 would cost lives because the OLE and eIND usage would be stopped.  CD16 and conditional EUA cannot be conducted at the same time because no one would enter the trial and risk getting placebo--they would make use of the EUA and have 100% certainty of receiving drug.  I think the FDA might have said we will grant the conditional EUA but will watch performance of the first 100 patients to ensure their recovery is inline with the critical patients in CD12. The continuation of the conditional EUA approval is dependent on how the patients fare.

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1 minute ago, chet said:

Optimistic view:

FDA encouraged conditional EUA for ethical reasons.  Forcing CYDY to conduct CD16 would cost lives because the OLE and eIND usage would be stopped.  CD16 and conditional EUA cannot be conducted at the same time because no one would enter the trial and risk getting placebo--they would make use of the EUA and have 100% certainty of receiving drug.  I think the FDA might have said we will grant the conditional EUA but will watch performance of the first 100 patients to ensure their recovery is inline with the critical patients in CD12. The conditional EUA approval is dependent on how the patients fare.

🤞🤞🤞🤞🤞🤞🤞

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2 hours 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.

I really hate the word play in the title of the press release.

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CytoDyn to Hold Webcast on March 22 to Provide an Update on COVID-19 Initiatives and Expected Regulatory Filings with the U.S., U.K., Canada, Philippines and Brazil

Why is the word 'expected' in there?  It pisses me off that they haven't filed yet.

And then in the body they use the word recent.

Quote

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.

 

Edited by Chaz McNulty
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2 minutes ago, Chaz McNulty said:

I really hate the word play in the title of the press release.

Why is the word 'expected' in there?  It pisses me off that they haven't filed yet.

From the body of the PR:

Quote

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.

It seems like they have filed in the UK, Canada and here.

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OMG This guy is trying to explain the new rules around shorting which come in effect tomorrow.  I have no idea if he explained them will because I couldn't stop staring at his wolf headband and his zit which is next to his philtrum and partially covered by his cheesy mustache.  

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This was posted on the Cytodyn facebook site.  Would love to hear a response.

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Dear Dr. Kelly,

I emailed you last week expressing my mounting concerns associated with the CYDY leadership. My concerns are not limited to me, personally, but express a growing sense of anxiety among many shareholders, stemming from recent (and not so recent) management activities.

To be clear, I have seen enough in the peer-review literature to reach the obvious conclusion: (leronlimab) LL works. Nevertheless, the last few days and weeks have been concerning. Given these concerns, the following issues are a collective set of questions that require attention. I realize you, and the rest of management, are likely quite busy with present matters - nevertheless, addressing the growing concerns of shareholders must also be a priority. Please note that I am communicating these questions on the CYDY Shareholders Facebook Page, a group that is home to >3000 members.

1) It has previously been said, by Dr. Mahboob Rahman, that receptor occupancy isn’t needed, specifically by the MHRA. Why has there been at least a 6 month delay in submission?

2) Receptor occupancy shouldn’t be an issue at this point. What’s the barrier to completion? Or is receptor occupancy the main issue?

3) How does Dr. Pourhassan not know the answer to the Philippines sales question posed at the most recent Investor Call? That’s literally his #1 job as CEO. As shareholders that have invested considerably, he needs to know the #1 priority is to find a sales outlet for LL. Anywhere!

4) Please address unequivocally when the CSP with Philippines is/was filed. Dr. Pourhassan explicitly mentioned a "48 hour" window of time at the most recent Investor Call - that was more than 1 week ago. What is the status with the submission to the Philippines?

5) Please address when the interim order with Health Canada will be filed.

6) Please address unequivocally whether a EUA will be filed (re: COVID-19) or has already been filed with the FDA?

7) What is the current status of Dr. Pourhassan's tenure as CEO? Shareholders are incredibly frustrated that little progress has been made toward viable revenue. There are constant delays and over statements bordering on the insane. Dividend talk from a company looking at a share offering? Multiple incredible bungles that most CEOs don’t make. The shorts fear LL. They know they’re safe with Dr. Pourhassan at the helm.

8 ) Have we fired the PR firm who did the press releases for CD-12? Why not? What is the company's marketing strategy going forward?

9) How is CYDY going to enroll CD16 knowing there is s/s benefit without ending eIND and OLE? Has the FDA been addressed with this ethical concern?

10) Is CYDY looking at anyone other than Amarex? They seem to have botched the trial for us and took a long time to turn around the data when compared to others (e.g., RLFTF).

An increasingly concerned shareholder,

Respectfully, Matei Georgescu

 

 

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1 hour ago, Chaz McNulty said:

This was posted on the Cytodyn facebook site.  Would love to hear a response.

 

Dear Dr. Kelly,

What price did you and your wife get for your shares during the review period?

What is the shelf life of the the LL in your warehouse?

Have did you beat NP to the offices supplies before the bankruptcy filing?

Will your company handle the bankruptcy filing better than the BLA filing?

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8 minutes ago, BassNBrew said:

Dear Dr. Kelly,

What price did you and your wife get for your shares during the review period?

What is the shelf life of the the LL in your warehouse?

Have did you beat NP to the offices supplies before the bankruptcy filing?

Will your company handle the bankruptcy filing better than the BLA filing?

The only relevant question IMO.

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Just posted this to reddit:

P-value vs.trial power--CYDY vs. Woodcock

Woodcock in her webinar yesterday implied that any trial needed to have 400+ participants for the trial to be powered enough to be statistically significant. She has also said that p-value shouldn't be an impediment to saving lives.

CYDY showed statistically significant results for the critical cohort in more than one endpoint with total patients far below 400.

The FDA has chosen 0.05 as the bright-line test as to statistical significance. If any trial shows a p-value less than 0.05, it should be recognized as statistically significant. If an endpoint shows a p-value of 0.10 or below, it means that the result was still overwhelmingly likely to be because of the drug but that there weren't enough patients--i.e. it was probably under powered or in other words, not enough participants.

That being said, any result that shows a p-value below 0.05 proves the drug's efficacy per the FDA's guideline. It's much harder to achieve that result with a low number of patients but it doesn't invalidate any result that is significant simply because there were a low number of patients. A statistically significant result stands regardless of the number of patients.

We have a wonder drug with a management team that is incredibly incompetent. We have to help them achieve conditional EUA approval. 

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23 minutes ago, Capella said:

That is definitely not the way the FDA works lol

From someone who's very credible in my book.

 

Quote

It is not made up. Have confirmed that the number is real and an associate has called the number and spoken with a clinical pharmacist. His advice was to have more MDs and Scientists call in to express their medical/scientific opinion on why leronlimab should receive more attention at the FDA.

Probably not a good idea to call as an 'investor' or to call with the intent to badger or be critical of the FDA, IMO.

However, I'm all about spreading the word to your MD friends and colleagues!

 

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47 minutes ago, Chaz McNulty said:

 I could see NP getting in trouble for falsely pumping the stock right before the release of trial data.

I hope he is locked up and if that's wishful thinking, at least hope the board is smart enough to remove him.

This was the final straw with this idiot for me.  I still can't believe he did that in the face of failed primary endpoints.  What a jackass

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3 minutes ago, Dwayne Hoover said:

I hope he is locked up and if that's wishful thinking, at least hope the board is smart enough to remove him.

This was the final straw with this idiot for me.  I still can't believe he did that in the face of failed primary endpoints.  What a jackass

also apparently "48hrs" is his new "2 weeks"

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4 hours ago, Capella said:

There’s always buyers for this crap. I don’t think it even got into the dollar range after this last debacle. 

I'm torn, but I think I am going to sell tomorrow and rebuy on Tuesday.  The stock price always seems to go down after a CC.

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Interesting post on SA that garnered 8 likes:

 

“This is gross. Recknor and his wife own CARE which is running the LH trial. CYDY is paying them $2.5m. Recknor invested $1m in November and got 670,000 shares at 1.50 when stock was above $2. He now is making 400k plus 50% cash bonus plus stock options. How the heck can this be legal. A man/family that has $4m tied to the company running a clinical trial.”

 

 

 

I see more and more of these types of notices when googling.  It always bothered me with the timeline and number of studies involved for HIV.  They need to clear this up.

https://clinicaltrials.gov/ct2/show/NCT02859961?term=leronlimab&draw=2&rank=9

 

 

“Kessler Topaz is one of the world’s foremost advocates in protecting the public against corporate fraud and other wrongdoing.  Our lawyers regularly take on the foremost defense attorneys—and win—in class actions, shareholder derivative suits, antitrust litigation and other complex litigation around the globe. We are proud to have recovered billions of dollars for our clients.”

https://www.ktmc.com/new-cases/cytodyn-inc-1#overview

 

 

Edited by The Blue Baron
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2 hours ago, The Blue Baron said:

I see more and more of these types of notices when googling.  It always bothered me with the timeline and number of studies involved for HIV.  They need to clear this up.

https://clinicaltrials.gov/ct2/show/NCT02859961?term=leronlimab&draw=2&rank=9

 

Can you unwind this one for me.  What is the exact issue?

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2 hours ago, The Blue Baron said:

Interesting post on SA that garnered 8 likes:

“This is gross. Recknor and his wife own CARE which is running the LH trial. CYDY is paying them $2.5m. Recknor invested $1m in November and got 670,000 shares at 1.50 when stock was above $2. He now is making 400k plus 50% cash bonus plus stock options. How the heck can this be legal. A man/family that has $4m tied to the company running a clinical trial.”

 

Here is the 8K discussing this.

https://www.marketwatch.com/investing/stock/cydy/SecArticle?guid=14802042

In a normal world, I would agree that this looks to be a huge conflict of interest.  And if you looked at the enrollment rate at the end of CD12, it may have had something to do with the sites run by CARE.

But if you look at this in comparison to what the rest of BP is doing, its really insignificant.  If we turned over a few rocks at Gilead, you would see way worse.  The same goes for the incestuous relationship that BP has with the FDA.  That's even more gross.

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Please sign this petition to help get this girl's grandmother LL.  The ####### doctor agreed to get LL and then changed his mind when he found out there was paperwork.

 

Quote

My 78 year old grandmother, Leida has COVID & is on a ventilator at NYP Hospital. Death is imminent. We like many others want every chance to fight for her life. We almost lost a 70 year old family member to COVID last year, he was given the medication leronlimab under compassionate use eIND. It saved his life. The drug manufacturer agreed to give leronlimab to grandma IF her doctor will complete the paperwork. This medication is FDA approved under compassionate use. Her attending, Dr. Gregg Rosner originally agreed, but backtracked when he realized the paperwork involved.  He said it is not worth his time & resources. @nyphospital supports him. Please join us in asking for compassion & give Leida the chance to live

 

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Can you unwind this one for me.  What is the exact issue?

My issue with it is the HIV BLA being delayed for so long and then there is the delay with starting the BLA.  They also have way too many trials on line for HIV.  I believe they consolidated some-As I believe there were more before.

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8 hours ago, Chaz McNulty said:

 

But if you look at this in comparison to what the rest of BP is doing, its really insignificant.  If we turned over a few rocks at Gilead, you would see way worse

Are you sure?  This seems like some major conflict of interest.    Seems shady to me but typical Cytodyn

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40 minutes ago, Dwayne Hoover said:

Are you sure?  This seems like some major conflict of interest.    Seems shady to me but typical Cytodyn

It’s awful out in the open if it’s shady.  They had to file and let everyone know. That’s like robbing a bank in broad daylight with no mask  and a name tag.  Well now that I think about it, perfectly in line with NP.  

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10 minutes ago, dkp993 said:

It’s awful out in the open if it’s shady.  They had to file and let everyone know. That’s like robbing a bank in broad daylight with no mask  and a name tag.  Well now that I think about it, perfectly in line with NP.  

It's a little suspect also, for the long hauler trial.  This trial is way more subjective about how the patient feels, and there's not a whole lot of analytical data compared to most trials.  Patients can be coached for sure.

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8 minutes ago, unckeyherb said:

No volume today, not a single post here.  I guess everyone is wearing concrete shoes waiting for this stupid CC tonight.  If there is not really positively impactful info given tonight, I am not looking forward to tomorrow. 

They probably just need to say that they applied for an EUA last week.  This will keep the stock where it is.  If they haven't applied, then we all get an opportunity at cheap shares tomorrow!

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12 minutes ago, Chaz McNulty said:

They probably just need to say that they applied for an EUA last week.  This will keep the stock where it is.  If they haven't applied, then we all get an opportunity at cheap shares tomorrow!

THANKS FOR THE CHEAP SHARES SHORTIES HAHAHAHAH

 

 

 

 

:rolleyes: 

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