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***OFFICIAL CYDY/Leronlimab Thread***

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3 hours ago, Otis said:

I can’t believe I’m still holding this.  It’s like melting money. 

If you got in when I think many of us did there is only 2 more months and can sell whatever you have as a 2-4 bagger paying long term capital gains.

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2 hours ago, Chaz McNulty said:

They are obviously pushing it back one hour to first allow for the FDA to report the new EUA drug for Covid-19.  You always allow the regulatory body to report first.

Right, guys?

Sure, sport. And Spike is still playing at that farm upstate.

:unsure:

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CytoDyn Receives Positive DSMC Recommendation after Interim Analysis for Leronlimab Phase 2b/3 COVID-19 Registrational Trial

October 20, 2020 6:00am EDT

https://www.cytodyn.com/newsroom/press-releases/detail/477/cytodyn-receives-positive-dsmc-recommendation-after-interim

DSMC recommends CytoDyn continue the study as planned, with the protocol defined sample size and power to achieve the primary endpoint

DSMC also requests another data review when enrollment reaches 293 patients (75%) to analyze all data, including survival rate at 42 days

VANCOUVER, Washington, Oct. 20, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today recommendations from the Data Safety Monitoring Committee (DSMC) following its review of the interim analysis of the Company’s Phase 2b/3 registrational trial in patients with severe-to-critical COVID-19. The interim analysis was performed on data from the first 195 (50%) of 390 planned patients.

The DSMC had three recommendations to consider following its review of the interim analysis:

Stop the trial due to safety concerns;

Continue the trial with modification (i.e., increase the sample size to maintain the power to achieve the primary endpoint); or

Continue the study as planned, with the protocol defined sample size and power to achieve the primary endpoint.

The DSMC recommends the trial continue without modification to achieve the primary endpoint and requests another interim analysis when enrollment reaches 75% level (or 293 patients) to review patient mortality and other clinical outcome data between the two study arms (leronlimab vs. placebo). Trial enrollment is currently at 230 patients. The Company is working diligently to accelerate patient enrollment in the U.S. and U.K. to achieve the enrollment goal of 293 patients as quickly as possible (potentially in 4-6 weeks), with the goal of full enrollment (390) before year end. Clinical trial sites in the U.K. are expected to initiate enrollment in the coming days.

CytoDyn’s Phase 2b/3 trial to evaluate the efficacy and safety of leronlimab for patients with severe-to-critical COVID-19 indications is a two-arm, randomized, double blind, placebo controlled, adaptive design multicenter study. Patients are randomized to receive weekly doses of 700 mg leronlimab, or placebo. Leronlimab and placebo are administered via subcutaneous injection. The study has three phases: Screening Period, Treatment Period, and Follow-Up Period. The primary outcome measured in this study is: all-cause mortality at Day 28. Secondary outcomes measured are: (1) all-cause mortality at Day 14, (2) change in clinical status of subject at Day 14, (3) change in clinical status of subject at Day 28, and (4) change from baseline in Sequential Organ Failure Assessment (SOFA) score at Day 14.

CytoDyn’s President and Chief Executive Officer, Nader Pourhassan, Ph.D., stated, “We are grateful to the DSMC members for their diligence, guidance and support. We are very pleased by the DSMC’s recommendation and this encouraging interim analysis adding to the promising data already demonstrated with emergency INDs in over 60 severe and critical COVID-19 patients. Concurrently, we are seeking ongoing guidance from the U.S. Food and Drug Administration and regulatory agencies in other countries for a swift regulatory approval pathway for leronlimab to treat COVID-19.

During today’s webcast, we will discuss in depth all of our priorities dedicated to advancing leronlimab as a therapeutic for COVID-19 and all of the opportunities that could be available to us in the coming months.” Dr. Pourhassan added, “We look forward to providing additional information during today’s webcast.”

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4 minutes ago, Don Hutson said:

CytoDyn Receives Positive DSMC Recommendation after Interim Analysis for Leronlimab Phase 2b/3 COVID-19 Registrational Trial

October 20, 2020 6:00am EDT

https://www.cytodyn.com/newsroom/press-releases/detail/477/cytodyn-receives-positive-dsmc-recommendation-after-interim

DSMC recommends CytoDyn continue the study as planned, with the protocol defined sample size and power to achieve the primary endpoint

DSMC also requests another data review when enrollment reaches 293 patients (75%) to analyze all data, including survival rate at 42 days

VANCOUVER, Washington, Oct. 20, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today recommendations from the Data Safety Monitoring Committee (DSMC) following its review of the interim analysis of the Company’s Phase 2b/3 registrational trial in patients with severe-to-critical COVID-19. The interim analysis was performed on data from the first 195 (50%) of 390 planned patients.

The DSMC had three recommendations to consider following its review of the interim analysis:

Stop the trial due to safety concerns;

Continue the trial with modification (i.e., increase the sample size to maintain the power to achieve the primary endpoint); or

Continue the study as planned, with the protocol defined sample size and power to achieve the primary endpoint.

The DSMC recommends the trial continue without modification to achieve the primary endpoint and requests another interim analysis when enrollment reaches 75% level (or 293 patients) to review patient mortality and other clinical outcome data between the two study arms (leronlimab vs. placebo). Trial enrollment is currently at 230 patients. The Company is working diligently to accelerate patient enrollment in the U.S. and U.K. to achieve the enrollment goal of 293 patients as quickly as possible (potentially in 4-6 weeks), with the goal of full enrollment (390) before year end. Clinical trial sites in the U.K. are expected to initiate enrollment in the coming days.

CytoDyn’s Phase 2b/3 trial to evaluate the efficacy and safety of leronlimab for patients with severe-to-critical COVID-19 indications is a two-arm, randomized, double blind, placebo controlled, adaptive design multicenter study. Patients are randomized to receive weekly doses of 700 mg leronlimab, or placebo. Leronlimab and placebo are administered via subcutaneous injection. The study has three phases: Screening Period, Treatment Period, and Follow-Up Period. The primary outcome measured in this study is: all-cause mortality at Day 28. Secondary outcomes measured are: (1) all-cause mortality at Day 14, (2) change in clinical status of subject at Day 14, (3) change in clinical status of subject at Day 28, and (4) change from baseline in Sequential Organ Failure Assessment (SOFA) score at Day 14.

CytoDyn’s President and Chief Executive Officer, Nader Pourhassan, Ph.D., stated, “We are grateful to the DSMC members for their diligence, guidance and support. We are very pleased by the DSMC’s recommendation and this encouraging interim analysis adding to the promising data already demonstrated with emergency INDs in over 60 severe and critical COVID-19 patients. Concurrently, we are seeking ongoing guidance from the U.S. Food and Drug Administration and regulatory agencies in other countries for a swift regulatory approval pathway for leronlimab to treat COVID-19.

During today’s webcast, we will discuss in depth all of our priorities dedicated to advancing leronlimab as a therapeutic for COVID-19 and all of the opportunities that could be available to us in the coming months.” Dr. Pourhassan added, “We look forward to providing additional information during today’s webcast.”

Thoughts on this Don?

I don't see it as good news.

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8 minutes ago, BassNBrew said:

Thoughts on this Don?

I don't see it as good news.

Bad news.  No EUA and they aren't going to pay the penalty to unblind.  If I still owned, I would put in a market order to sell before open.  They did add another carrot to dangle with another interim analysis at 75% enrollment.  It's also interesting that they'll look at survival at 42 days.  Maybe some placebo patients died in days 29-42?

Edited by Don Hutson

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9 minutes ago, Don Hutson said:

Bad news.  No EUA and they aren't going to pay the penalty to unblind.  If I still owned, I would put in a market order to sell before open.  They did add another carrot to dangle with another interim analysis at 75% enrollment.  It's also interesting that they'll look at survival at 42 days.  Maybe a few more placebo patients died in days 29-42?

By itself, this is not bad news.  It is expected news.  People who see this as bad news are the people looking to flip it. 

What IS concerning is the fact they still have NO revenue and they need to continue several trials they are working, and that is a huge issue.  At the current rate, they will be out of money by the end of the year.

Which means likely dilution at a minimum.  I think the best news they could give today is a buyout, but what price would they get at this point?  I still think NP is too stubborn to do this, but the writing is on the wall on this drug.  There is no chance they make it to market without some help.

This is all just my opinion.  Still hoping for the best possible outcome for shareholders.  

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Long-term it’s good news. The drug appears to be working or they would have cancelled the trial. Short-term, probably won’t really make a difference one way or the other. Not sure how it could be construed as bad news unless somebody was hoping to hit the jackpot tomorrow and that was just never realistic. 

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3 minutes ago, Caesar said:

By itself, this is not bad news.  It is expected news.  People who see this as bad news are the people looking to flip it. 

What IS concerning is the fact they still have NO revenue and they need to continue several trials they are working, and that is a huge issue.  At the current rate, they will be out of money by the end of the year.

Which means likely dilution at a minimum.  I think the best news they could give today is a buyout, but what price would they get at this point?  I still think NP is too stubborn to do this, but the writing is on the wall on this drug.  There is no chance they make it to market without some help.

This is all just my opinion.  Still hoping for the best possible outcome for shareholders.  

Hoping personally for a buyout at 10-12 range?

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Just now, Capella said:

Hoping personally for a buyout at 10-12 range?

I am right there with you.  I would take my meager (compared to a lot of people here) additions and move on to something else.  

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Just now, Don Hutson said:

CYDY is up in Stuttgart.  $2.58 Euros which is $3.05 USD

I know you read the investorshangout board as well.  There are a couple people there spinning it as excellent news.  I agree with the sentiment, but I still don't see where the money comes from unless it is from dilution or a buyout.

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10 minutes ago, Caesar said:

I know you read the investorshangout board as well.  There are a couple people there spinning it as excellent news.  I agree with the sentiment, but I still don't see where the money comes from unless it is from dilution or a buyout.

If it works, the money will come from somebody. If the drug can help with covid it’s not just going to be set aside. 

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16 minutes ago, Caesar said:

I know you read the investorshangout board as well.  There are a couple people there spinning it as excellent news.  I agree with the sentiment, but I still don't see where the money comes from unless it is from dilution or a buyout.

They are spinning it.  There are also people on Investor's Hangout who think Nader is the best CEO ever.  Some of them talk about CYDY the way a bible thumper talks about Jesus.  Results from the 75% interim analysis will come in February at the earliest but could come in March-May.  But if there was no EUA or unblinding with the 50% interim, then there isn't much chance with the 75%.  We probably aren't going to find out any data until full enrollment.  Those results will probably come in the summer of 2021.

Edited by Don Hutson

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So I am clear, the bad news is that CYDY didn't receive EUA and the results from the interim analysis weren't so unbelievably good that they stopped the trials.  Correct?  Beyond that I see this as good news in that they didn't stop or modify the trial.  This is kind of what I was expecting honestly.  Don't see this as bad news, just not great news.

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1 minute ago, unckeyherb said:

So I am clear, the bad news is that CYDY didn't receive EUA and the results from the interim analysis weren't so unbelievably good that they stopped the trials.  Correct?  Beyond that I see this as good news in that they didn't stop or modify the trial.  This is kind of what I was expecting honestly.  Don't see this as bad news, just not great news.

Exactly right. 

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50 minutes ago, Don Hutson said:

The DSMC had three recommendations to consider following its review of the interim analysis:

1. Stop the trial due to safety concerns;

 

What do they mean by this?  Do they mean stop the trial because too many deaths in the placebo group... in the LL group?  or both?  Do they mean some other safety issue?  

The lack of clarification is troubling.  What was there reasoning for including this sentence in the list of recommendations?  And since it is number 1 does that mean it is their first recommendation?  

I expect a boat load of spin in the webcast.  

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2 minutes ago, Jayrok said:

What do they mean by this?  Do they mean stop the trial because too many deaths in the placebo group... in the LL group?  or both?  Do they mean some other safety issue?  

The lack of clarification is troubling.  What was there reasoning for including this sentence in the list of recommendations?  And since it is number 1 does that mean it is their first recommendation?  

I expect a boat load of spin in the webcast.  

I think this.

ETA, but obviously LL is safe, so this was probably not considered.

Edited by unckeyherb
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2 minutes ago, Jayrok said:

What do they mean by this?  Do they mean stop the trial because too many deaths in the placebo group... in the LL group?  or both?  Do they mean some other safety issue?  

The lack of clarification is troubling.  What was there reasoning for including this sentence in the list of recommendations?  And since it is number 1 does that mean it is their first recommendation?  

I expect a boat load of spin in the webcast.  

Stopping the trial because of deaths in the treatment arm was an option that the DMSC had.  But we know the leronlimab is 100% safe so that wasn't going to happen.

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So some of you think this isn't bad news because you were expecting bad news.  I guess if you set your expectations low enough that you'll never receive bad news.

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1 minute ago, Don Hutson said:

So some of you think this isn't bad news because you were expecting bad news.  I guess if you set your expectations low enough that you'll never receive bad news.

No, I was literally expecting this. I think it will get some kind of approval the first half of next year. 

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I just sold half of my remaining at $3.00.  It won't be long until people realize they are waiting until Feb/March for more news.  And I doubt that uplisting is in the cards, as they never talk about that anymore.

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Out at $2.99, without a scintilla of regret. My return is 249.2%. Deeply grateful to chet and still down for a meetup at the Waldorf-Astoria on the Vegas Strip.

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22 minutes ago, Capella said:

No, I was literally expecting this. I think it will get some kind of approval the first half of next year. 

Not sure anyone will be left alive to approve it by then.

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14 minutes ago, BassNBrew said:

Not sure anyone will be left alive to approve it by then.

Dogs and cats, living together...mass hysteria!!

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An EUA not being granted isn't the only bad news.  The trial not being halted for efficacy shows that leronlimab isn't an amazing drug against Covid.  It might still be a good drug against Covid.  But it lost some of its ceiling.

Edited by Don Hutson

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1 minute ago, Don Hutson said:

An EUA not being granted isn't the only bad news.  The trial not being halted for efficacy shows that leronlimab isn't an amazing drug against Covid.  It might still be a good drug against Covid.  But it lost some of its ceiling.

I just don't understand why they wouldn't take an early peak.  If NP is so sure....

The only thing I can think of is that they are afraid of what the results will show.

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2 minutes ago, Chaz McNulty said:

I just don't understand why they wouldn't take an early peak.  If NP is so sure....

The only thing I can think of is that they are afraid of what the results will show.

Maybe Nader knows exactly what the results are.  The DSMB was chosen by CytoDyn.

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13 minutes ago, Don Hutson said:

 

huh?

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3 minutes ago, [icon] said:

huh?

Philippines (our ace in the hole :unsure:)

Edited by Don Hutson

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1 minute ago, Don Hutson said:

Philippines

Link is no good. What's the details? 
EDIT: NM Looks like they've hired someone to apply for approval in PHIL
https://www.globenewswire.com/news-release/2020/10/13/2107107/0/en/CytoDyn-Appoints-Chiral-Pharma-to-Secure-Leronlimab-for-Local-FDA-Approval-in-Philippines.html

 

Edited by [icon]

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29 minutes ago, [icon] said:

Link is no good. What's the details? 
EDIT: NM Looks like they've hired someone to apply for approval in PHIL
https://www.globenewswire.com/news-release/2020/10/13/2107107/0/en/CytoDyn-Appoints-Chiral-Pharma-to-Secure-Leronlimab-for-Local-FDA-Approval-in-Philippines.html

 

You need to update your subscription to the Manila Post.  I can't believe you let it run out!

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Where is @chet ? 

Did you sell the rest of your shares?  Still holding?  Any insight?  

Everyone is doing a great job updating what is going on and hoping that we hit at least a double, if not a homerun (again).  However, still not uplisted, running out of money and seems like NP is grasping at straws to get approval.  

WHen is the call scheduled?  I may have to get out before it takes place.  

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15 minutes ago, Bluto Blutarsky said:

Very minor mildly interesting (to me) number-

held my institution went from .0373 to .0432

 

 also could mean nothing

 

 

What means this?

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4 minutes ago, Chaz McNulty said:

What means this?

No one important owns the stock

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1 hour ago, Getzlaf15 said:

No one important owns the stock

Ouch.  Self esteem just took a dump....

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My read is that the increasing effectivity of SOC narrowed the gap between the PL and LL arms enough so p < .05 was not achieved. It comes down to how quickly they can get that data.  

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Paper

Clinical Characteristics and Outcomes of COVID-19 Patients Receiving Compassionate Use Leronlimab

Bryant Yang, M.D, Jennifer A Fulcher, M.D, Jenny Ahn, R.N, Marlene Berro, M.S, David Goodman-Meza, M.D, Kush Dhody, M.B.B.S, Jonah B Sacha, Ph.D, Arash Naeim, M.D, Otto O Yang, M.D

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Seems like more good news for the long-term. Hoping for a buyout. 

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7 minutes ago, Capella said:

Seems like more good news for the long-term. Hoping for a buyout. 

Why would some offer 2B when the can buy the rights to LL and the"$58k" in used printers and coffee makers on the courthouse steps.

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The Phillipines is yet another diversion if I had to guess.  Sounds promising on paper but if it ever gets approved there,  your guess is as good as mine.

Nader seems to like to trumpet other countries when he is need of some good news, seen this one before, haven't really seen the interest come through from the country in the end.  Maybe this is different.

I sold a little more today.  I haven't completely given up but am discouraged.  Completing the BLA for HIV is super important, not sure what the hold up there is but they really struggle to complete anything.

Nader has to go but we all know that.   Better leadership would improve confidence all around and may help get more traction both  with the FDA and also in the media.

Lastly, why hasn't Patterson or any other Doctor been published?  Would like validation for this.

Edit i see Dr Yang got printed today in Oxford Academic.  Definitely a step in the right direction but I believe it is the Editor who does the review not any outside doctors.

https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaa1583/5932277#.X48nirB3Wqg.twitter

Edited by Dwayne Hoover

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