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Posted On: 04/16/2024 6:38:57 PM
Post# of 148899
NP/KK explain this filing / history:
Under Table of Contents:
PRO 140 was originally developed by Progenics Pharmaceuticals, Inc. (“Progenics”), which led, and contributed to funding of, PRO 140 development and trials through 2011. We acquired the asset from Progenics in October 2012. Jeffrey M. Jacobson, M.D., Professor of Medicine, Microbiology and Immunology, Chief, Drexel University College of Medicine (“Drexel”), has conducted prior research relating to PRO 140, and is continuing to pursue one clinical trial partially funded through one grant awarded to Dr. Jacobson by the National Institutes of Health (“NIH”). We have also recently completed a successful Phase 2b clinical trial exploring PRO 140 as a short-term treatment substitution (as a monotherapy of PRO 140) for existing drug regimens.
To facilitate our self-funded and sponsored clinical research plans, we have engaged Amarex Clinical Research, LLC (“Amarex”), our principal contract research organization, to provide comprehensive clinical trial services, including managing our chemistry and manufacturing control (“CMC”) activities.
In furtherance of our business strategy, in mid-2014 we entered into a manufacturing agreement with a contract manufacturing organization to initiate preparations for the potential future manufacturing of additional PRO 140."
https://www.sec.gov/Archives/edgar/data/11756...145ds1.htm
That's a 2015 filing & timeline 2014 comment points to even earlier hiring than 2014.
Haven't back tracked further out of not giving a dam, he's guilty even by this dated filing.
______
Frwd to this:
Dec 01, 2021:
"today announced it has completed submission of all the major sections of CMC modules to FDA, some remaining supporting documentation will be submitted under Regional Information before the end of this week.
CMC is a critical part of CytoDyn’s Biologics License Application (“BLA”) for HIV. This submission was made under rolling review consistent with guidance from the U.S. Food and Drug Administration (“FDA”). Only the clinical section remains to be submitted."
https://www.biospace.com/article/releases/cyt...ubmission/
( "consistent with guidance" )
_______
Im going to point out the obvious to what NP/KK, just said there:
"This submission was made under rolling review consistent with guidance from the U.S. Food and Drug Administration (“FDA”)."
Like i've said, them now "teaming" to challenge the FDA & KK said was never given a chance by FDA to submit a COMPLETE BLA...
Total bullshit & after getting around to double checking Amarex's dated to NP/Cytodyn ---- they better settle early with Cytodyn.
I would NOT, want to leave it open to an Arbitrators decision.
Outside of proving bias against you, an Arbitrator can not be appealed.
This case will settle out of the blue --- of course i saved the cherry reason for last:
Admitted filing it incomplete.
Under Table of Contents:
PRO 140 was originally developed by Progenics Pharmaceuticals, Inc. (“Progenics”), which led, and contributed to funding of, PRO 140 development and trials through 2011. We acquired the asset from Progenics in October 2012. Jeffrey M. Jacobson, M.D., Professor of Medicine, Microbiology and Immunology, Chief, Drexel University College of Medicine (“Drexel”), has conducted prior research relating to PRO 140, and is continuing to pursue one clinical trial partially funded through one grant awarded to Dr. Jacobson by the National Institutes of Health (“NIH”). We have also recently completed a successful Phase 2b clinical trial exploring PRO 140 as a short-term treatment substitution (as a monotherapy of PRO 140) for existing drug regimens.
To facilitate our self-funded and sponsored clinical research plans, we have engaged Amarex Clinical Research, LLC (“Amarex”), our principal contract research organization, to provide comprehensive clinical trial services, including managing our chemistry and manufacturing control (“CMC”) activities.
In furtherance of our business strategy, in mid-2014 we entered into a manufacturing agreement with a contract manufacturing organization to initiate preparations for the potential future manufacturing of additional PRO 140."
https://www.sec.gov/Archives/edgar/data/11756...145ds1.htm
That's a 2015 filing & timeline 2014 comment points to even earlier hiring than 2014.
Haven't back tracked further out of not giving a dam, he's guilty even by this dated filing.
______
Frwd to this:
Dec 01, 2021:
"today announced it has completed submission of all the major sections of CMC modules to FDA, some remaining supporting documentation will be submitted under Regional Information before the end of this week.
CMC is a critical part of CytoDyn’s Biologics License Application (“BLA”) for HIV. This submission was made under rolling review consistent with guidance from the U.S. Food and Drug Administration (“FDA”). Only the clinical section remains to be submitted."
https://www.biospace.com/article/releases/cyt...ubmission/
( "consistent with guidance" )
_______
Im going to point out the obvious to what NP/KK, just said there:
"This submission was made under rolling review consistent with guidance from the U.S. Food and Drug Administration (“FDA”)."
Like i've said, them now "teaming" to challenge the FDA & KK said was never given a chance by FDA to submit a COMPLETE BLA...
Total bullshit & after getting around to double checking Amarex's dated to NP/Cytodyn ---- they better settle early with Cytodyn.
I would NOT, want to leave it open to an Arbitrators decision.
Outside of proving bias against you, an Arbitrator can not be appealed.
This case will settle out of the blue --- of course i saved the cherry reason for last:
Admitted filing it incomplete.
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