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***OFFICIAL CYDY/Leronlimab Thread*** (1 Viewer)

chet said:
Wow
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Not surprised. FDA and CDC have been compromised. Choosing to push Trump's agenda. 

The FDA forgoing Phase 3 trials for vaccines is ridiculous for vaccines. 

I wish these lax guidelines would apply to LL, but we now know the FDA are a bunch of crooks. 

Sadly, CYDY needs to link up with Big Pharma in order to get anything done.

 
Charlie Harper said:
Not surprised. FDA and CDC have been compromised. Choosing to push Trump's agenda. 

The FDA forgoing Phase 3 trials for vaccines is ridiculous for vaccines. 

I wish these lax guidelines would apply to LL, but we now know the FDA are a bunch of crooks. 

Sadly, CYDY needs to link up with Big Pharma in order to get anything done.
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The thing that kills me is that no way does Hahn turn around and give any break to Cytodyn.  He won't take any chances there.  

 
Global Health Leaders Join CytoDyn's Scientific Advisory Board

September 01, 2020 6:00am EDT

https://www.cytodyn.com/newsroom/press-releases/detail/468/global-health-leaders-join-cytodyns-scientific-advisory

Leading experts in the fields of HIV, Oncology, Rheumatology, and NASH join together to facilitate the best approaches to utilize multiple opportunities for leronlimab

VANCOUVER, Washington, Sept. 01, 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 the formation and initial members of its Scientific Advisory Board today including leading HIV, NASH, Oncology, and Rheumatological clinical experts and researchers.

CytoDyn's Scientific Advisory Board members include Dr. Gero Hütter, German hematologist, best known for the bone marrow transplant resulting in the cure of the first HIV patient; Dr. Hope S. Rugo, Professor, Department of Medicine (Hematology/Oncology) and Director of the Breast Oncology Clinical Trials Education Program at University of California San Francisco; Dr. Richard T. Maziarz, Professor, Medical Director of the Adult Blood and Marrow Stem Cell Transplant and Cellular Therapy Program Knight Cancer Institute at Oregon Health & Science University (OHSU); Dr. Jonah B. Sacha, Professor, VGTI-Vaccine and Gene Therapy Institute at OHSU; Dr. Mazen Noureddin, a hepatologist and Director, Cedars-Sinai Liver Transplant Program in Los Angeles; Dr. Norman B. Gaylis, nationally and internationally recognized specialist in rheumatology and autoimmune diseases; Dr. Eric D. Mininberg, Oncology Specialist, Piedmont Cancer Institute, a member of the MD Anderson Cancer Network; and Dr. Lishomwa Ndhlovu, Assistant Professor, Immunology,  Department of Medicine, Division of Infectious Disease at Weill Cornell Medicine in New York.

Scott A. Kelly, M.D., Chief Medical Officer of CytoDyn, said, "This team of advisors is passionately committed to bringing new treatment options to patients facing some of the world's most challenging health conditions including HIV, cancer, NASH, and rheumatological disorders. We are grateful to be working with such a distinguished group of medical and academic professionals."

Dr. Kelly continued, "The combined years of medical practice, investigative trial experience and publications are more than impressive; we believe the collective wisdom and experience of these leaders will be the pathway to rapidly bringing leronlimab to the global health community. We will continue to expand this team with a focus on specific oncology indications, neurology, pulmonary and critical care, virology, and autoimmune diseases."
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eaganwildcats said:
Isn't Lenzilumab (HGEN) an IL-6 inhibitor as well?
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Leronlimab also decreases IL-6.  Decreasing IL-6 is one way that might help patients.  But there is more to solving Covid symptoms than just IL-6 suppression.  And leronlimab and lenzilumab both have other positive effects.  Some of the results of the Kevzara trial showed marginal benefits.  But it also seems to be a toxic drug with its own bad side effects.  There is little reason to proceed with a drug that only shows marginal benefit while having bad side effects.

lenzilumab graphic

 
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This_Guy said:
Article about a patient in Texas that was in one of the trials.

https://www.houstonchronicle.com/lifestyle/renew-houston/health/article/plasma-covid-ut-health-texas-cure-expert-doctor-tx-15528307.php?fbclid=IwAR0_AU9iu4Wim49w8n61hzhpj--taGeQovL4Lfj-qHUd5xsRjBUx2VfPBKI

Interesting that they were given plasma and (potentially) LL.
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We really need that data from the S/C trial. That could be the huge result that can’t be ignored. Sounds like that one person might have qualified under severe not mild.

 
Don Hutson said:
Leronlimab also decreases IL-6.  Decreasing IL-6 is one way that might help patients.  But there is more to solving Covid symptoms than just IL-6 suppression.  And leronlimab and lenzilumab both have other positive effects.  Some of the results of the Kevzara trial showed marginal benefits.  But it also seems to be a toxic drug with its own bad side effects.  There is little reason to proceed with a drug that only shows marginal benefit while having bad side effects.

lenzilumab graphic
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That data did not show that it was toxic, just that its toxicity was the same as the placebo.

 
Judge Smails said:
Dr Topol is no hack. One of the more progressive minds in healthcare. Lots of books, speaking engagements. Scripps institute. He’s spot on 
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I wish he had gotten a couple of other established editors like NEjAMA or Lancet to co-sign

 
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@Whyatt

You done crunching those numbers?

For the bet you offered here, then called us out a welchers.  But then why offer at bet here?  

Just like your objective analysis.

 
Golf Guy 69 said:
@Whyatt

You done crunching those numbers?

For the bet you offered here, then called us out a welchers.  But then why offer at bet here?  

Just like your objective analysis.
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No, I didn’t call everyone welchers. I was having fun with the 2016 election bet which was all the rage 4 years ago.

I will win the bet, but a substantial wager will change the tone of the discussion.

Why do you think my analysis isn’t objective? What’s in it for me?

 
Whyatt said:
No, I didn’t call everyone welchers. I was having fun with the 2016 election bet which was all the rage 4 years ago.

I will win the bet, but a substantial wager will change the tone of the discussion.

Why do you think my analysis isn’t objective? What’s in it for me?
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What's the odds?

 
NP wants to give 25% (25 million shares)of the recent share increase for incentives to company employees (all 20 0f them). Also a 1% incentive increase of any outstanding shares each year.

What a crock. NP said he didn't want to dilute shareholders. Dont think so. Also said those shares would be held in reserve and used only if needed.

Apparently they are needed to enrich company employees and board members.

Mind you doing all this without delivering anything to date in revenues or approvals.

The cc tomorrow must be a humdinger. Expect to hear EAUs have been granted throughout the world. BLA has been accepted. company  has been uplisted and we now have a partnership with BP. How else can you justify this.

 
Very in depth interview today with NP about history of LL and NP's involvement and stewardship of the company

https://biotechintelligence.blogspot.com/2020/09/interviews-with-cytodyn-nader.html

As lead in to interviews writer said

Consequently, CytoDyn has applied to the FDA for right to sell the product under an EUA, an emergency use authorization for an unmet medical need.  The government is under pressure to provide medicines against this malignant virus, but the problem is that even though the FDA authorized this small Phase 2 study of 75, they did not intend to approve it for sale on the basis of such a small study.  So, they have to decide in this time of crisis where 10,000 people are dying each month whether to give it the green light, or hold out for more results.  It will require nerves of steel whichever way they decide.  Usually, FDA requires a larger Phase 3 to further establish the good results of a Phase 2 study.  So, approval is not in the bag.  It is typically a matter of numbers.  Working in their favor are the excellent safety results so far.  More than 800 HIV patients have been tested with no death or serious complications.  And now there are more cancer subjects added to that, and the unusually good safety results of the Covid-19 patients.

When the CEO Dr. Nader Pourhassan was queried about doing another trial for FDA, he’s not bothered.  A double blind study has just been completed in which the results were wonderful, indeed all of their trial results have been positive.  Though sensibly they have pursued trials where the receptor CCR5 was implicated and studied and written about in the medical literature, so there were theoretical reasons to believe it might work.

 
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Moonlight said:
NP wants to give 25% (25 million shares)of the recent share increase for incentives to company employees (all 20 0f them). Also a 1% incentive increase of any outstanding shares each year.

What a crock. NP said he didn't want to dilute shareholders. Dont think so. Also said those shares would be held in reserve and used only if needed.

Apparently they are needed to enrich company employees and board members.

Mind you doing all this without delivering anything to date in revenues or approvals.

The cc tomorrow must be a humdinger. Expect to hear EAUs have been granted throughout the world. BLA has been accepted. company  has been uplisted and we now have a partnership with BP. How else can you justify this.
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Link? If true, I may just sell everything. $3.5M bonuses for each employee is ridiculous, especially considering where they are. I'm still up a nice chunk of change, way less that if I had sold all close to $10 or at $6.50 (sold 1/3). I've got other things that I have been thinking about buying so I don't want to sit in a stock when this type of stuff happens.

 
Moonlight said:
NP wants to give 25% (25 million shares)of the recent share increase for incentives to company employees (all 20 0f them). Also a 1% incentive increase of any outstanding shares each year.

What a crock. NP said he didn't want to dilute shareholders. Dont think so. Also said those shares would be held in reserve and used only if needed.

Apparently they are needed to enrich company employees and board members.

Mind you doing all this without delivering anything to date in revenues or approvals.

The cc tomorrow must be a humdinger. Expect to hear EAUs have been granted throughout the world. BLA has been accepted. company  has been uplisted and we now have a partnership with BP. How else can you justify this.
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I do not believe this is what the document is saying. If I read it correctly they put 25M shares in the pot back in 2012 to use as incentives. They currently have about 800K left. They want to authorize 25M more to add to the pot to be available for incentives from not until 2030.  So, the 25M are not for current employees, they are for hires over the next 10 years.  Seems reasonable for a hopefully rapidly expanding company.

 
needanap said:
I do not believe this is what the document is saying. If I read it correctly they put 25M shares in the pot back in 2012 to use as incentives. They currently have about 800K left. They want to authorize 25M more to add to the pot to be available for incentives from not until 2030.  So, the 25M are not for current employees, they are for hires over the next 10 years.  Seems reasonable for a hopefully rapidly expanding company.
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On the one hand it seems like mistaken priorities, but on the other hand if they are going to ramp up to be a real drug company, they're going to need a pile of cash like that to incentive the best recruits to come work for them.

 
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cosjobs said:
On the one hand it seems like mistaken priorities, but on the other hand if they are going to ramp up to be a real drug company, they're going to need a pile of cash like that to incentive the best recruits to come work for them.
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Agree on both accounts. 

 
needanap said:
I do not believe this is what the document is saying. If I read it correctly they put 25M shares in the pot back in 2012 to use as incentives. They currently have about 800K left. They want to authorize 25M more to add to the pot to be available for incentives from not until 2030.  So, the 25M are not for current employees, they are for hires over the next 10 years.  Seems reasonable for a hopefully rapidly expanding company.
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More than reasonable. You have to pay for good people. I’m sure this will get twisted though. 

 
[icon] said:
VERY interesting study from the supercomputer at ORNL: 

https://elemental.medium.com/a-supercomputer-analyzed-covid-19-and-an-interesting-new-theory-has-emerged-31cb8eba9d63

TLDR: It's a Bradykin storm, not a cytokine storm that causes the effects we see. And there are quite a few existing drugs that help vs that. 
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Jacobson’s team says in their paper that “the pathology of Covid-19 is likely the result of Bradykinin Storms rather than cytokine storms,” which had been previously identified in Covid-19 patients, but that “the two may be intricately linked.”
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Maybe a cocktail of CYDY with an ACE inhibitor is the key?

 
needanap said:
I do not believe this is what the document is saying. If I read it correctly they put 25M shares in the pot back in 2012 to use as incentives. They currently have about 800K left. They want to authorize 25M more to add to the pot to be available for incentives from not until 2030.  So, the 25M are not for current employees, they are for hires over the next 10 years.  Seems reasonable for a hopefully rapidly expanding company.
Click to expand...
Why would they need to create/allocate shares today for employees on staff 5-10 years from now.  Seems unusual to me and I wish I could trust these guys to not dip into the honey pot....but I'm nowhere close to that.  NP needs more shares to replace the ones he has already sold.

 
Someone with business chops tell me how tell me how to feel:

Moonlight said:
         
Reasons for the Amended and Restated 2012 Equity Incentive Plan (See page 12): The primary reasons for amending and restating our 2012 Equity Incentive Plan are to increase the number of shares of common stock authorized for issuance under the 2012 Plan by 25,000,000 shares, to add an evergreen renewal provision to the 2012 Plan, and to extend the term of the 2012 Plan to September 30, 2030. Other amendments reflected in the Amended and Restated 2012 Plan include a limit on nonemployee director awards and incentive stock option awards, and certain technical and clarification changes.

     •         
Effect of Approving the Amended and Restated 2012 Equity Incentive Plan (See page 11): If the Amended and Restated 2012 Equity Incentive Plan is approved, the total number of shares of Common Stock available for grant under the Plan will be increased from 25,000,000 shares to 50,000,000 shares, the number of shares available to be issued under the Plan will be increased each fiscal year in an amount equal to 1% of the total outstanding shares on the last day of our prior fiscal year, and the term of our plan will be extended for an additional ten years.

     •         
Effect of Not Approving the Amended and Restated 2012 Equity Incentive Plan (See page 12): If the Amended and Restated 2012 Equity Incentive Plan fails to obtain the vote required for approval, our existing 2012 Equity Incentive Plan will remain in place, and the number of shares reserved for future issuance under the 2012 Equity Incentive Plan will remain at 25,000,000. We currently have 800,897 shares available for issuance under our 2012 Equity Incentive Plan, which is not sufficient to cover the grants we have already made to our executive officers and non-employee directors for fiscal year-end 2021, nor will it be sufficient to cover grants we need to make to our employees and new hires in the future. In the event this proposal fails to obtain the vote required for approval, the Company will be limited in its ability to provide equity incentive compensation to current and future employees or board members and, as a result, we may not be able to retain current employees or attract new employees or board members.

     •         
Recommendation of the Board (See pages Notice of Annual Meeting of Stockholder, 5, 19, 32, 33): The Board recommends that you vote FOR the election of all nominees for director, as well as FOR Proposals 2, 3 and 4.
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Setting up compensation for current executives and future high quality employees is ok but the company still has no revenue.  They really need to give some good news if they're going to ask shareholders to approve another stock increase.  Are they going to follow this up with wonderful news that will generate revenue?  History says no but we can still hope.  

 
Jayrok said:
Setting up compensation for current executives and future high quality employees is ok but the company still has no revenue.  They really need to give some good news if they're going to ask shareholders to approve another stock increase.  Are they going to follow this up with wonderful news that will generate revenue?  History says no but we can still hope.  
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Either they have news, or they are extremely confident they will shortly, or they are extremely stupid. I’m leaning towards #2. 

 
djmich said:
Why would they need to create/allocate shares today for employees on staff 5-10 years from now.  Seems unusual to me and I wish I could trust these guys to not dip into the honey pot....but I'm nowhere close to that.  NP needs more shares to replace the ones he has already sold.
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Probably because they think the stock is at its nadir

 
Jayrok said:
Setting up compensation for current executives and future high quality employees is ok but the company still has no revenue.  They really need to give some good news if they're going to ask shareholders to approve another stock increase.  Are they going to follow this up with wonderful news that will generate revenue?  History says no but we can still hope.  
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The call this afternoon better be good.

 
djmich said:
Why would they need to create/allocate shares today for employees on staff 5-10 years from now.  Seems unusual to me and I wish I could trust these guys to not dip into the honey pot....but I'm nowhere close to that.  NP needs more shares to replace the ones he has already sold.
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It’s extremely common.  Pretty much every equity compensation plan I’ve worked on (which is a lot) has a ten-year term.  Since they are required to go to shareholders for approval, they have these longer terms so they’re not going back every year to ask for more.  They will have had a comp consultant come in to analyze and recommend the number of share to allocate to the new (or in this case amended) plan.

Also, to the separate point that the company had no revenue, that’s exactly why stock compensation is even more crucial to incentivize employees to come there.  

 
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