Cytodyn Inc (CYDY)

[theswordman]

Here is timeline of response to RTF letter:

The FDA noted in the RTF Letter the BLA omitted certain information and had various inadequacies in data analyses which rendered the application incomplete for the FDA’s review, and which required substantial amounts of additional analyses along with corrections to datasets. The FDA noted the four following “basic deficiencies”:

#1--An absence of analyses needed to permit substantive clinical, statistical, clinical virology and clinical pharmacology review of the proposed dose. As noted above in the “Background” section, this issue arose as a consequence of a concurrently running clinical trial to investigate alternative dosages. The Phase 3 CD02 trial net its primary endpoint with a 350 mg dose and concurrently, the Company’s Phase 2b/3 CD03 investigative trial was demonstrating a higher dose of 700 mg was over 90% more effective, thus the Company agreed to change its BLA filing from 350 mg to 700 mg.

#2--Quality issues regarding electronic datasets, specifically an absence of certain variables and analysis group flags in files containing primary efficacy data needed for substantive review of the product’s effectiveness and safety. The Agency also noted numerous instances of missing data and files not adequately defined or properly indexed.

#3--The submission did not include demographic analyses of subpopulations with regard to effectiveness, and the Integrated Summary of Effectiveness was omitted from the submission. Certain sections regarding adverse effects on certain subgroups were not sufficiently detailed and/or did not include analyses of safety by race or ethnicity.

#4--The submission did not include data from studies conducted with the drug in the device or information on the manufacturer of the syringe and needles.

See p. 8.
https://www.sec.gov/Archives/edgar/data/0001175680/000119312521091607/filename1.htm

“An absence of analyses needed to permit substantive clinical, statistical, clinical virology and clinical pharmacology review of the proposed dose” is the Dose Justification Report Cytodyn committed to provide in December 2018.

Then 1 ½ years later on May 11, 2020, they filed a BLA without this analysis.
Nodder had to know that FDA would reject the application?? No way FDA would approve the BLA without it. Yet Cytodyn “confirmed on May 11, 2020, it submitted all remaining parts of the Company’s Biologics License Application (“BLA”) for leronlimab as a combination therapy with HAART” https://www.cytodyn.com/newsroom/press-releases/detail/430/cytodyn-completed-submission-of-all-remaining-parts-of
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The nodder fans , without any supporting evidence, blamed receptor occupancy testing error on Dr. Patterson. The only real evidence of Dr. Patterson's role in receptor occupancy testing was provided by him. Dr. Patterson showed that IncellDX did not do any receptor occupancy testing for HIV Combo trial and that he did accurate receptor occupancy testing for about 1/3 of the monotherapy trial. Listen to minutes 25:20 - 27:06 the 9/6/21 Zoom conference call

Nodder has not disputed any of this. Nodder did say he would release to the public domain (whatever that means) all the issues of RO--we are still waiting