Cytodyn Inc (CYDY)

[ClosetInvestor]

“When refusal to file was issue , it was not because of not clinically statistical results, it was because of collateral things , not finished ROT , wrong papers file etc.”

As you can see below, from CYDY’s official correspondence with the SEC, the ROT was not one of the issues the FDA mentioned in the RTF, per the official statement below.

“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.

“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”:

This blurb is two paragraphs below, in the middle of the paragraph and is the only time the RO is mentioned. Notice the verbiage as CYDY chooses to use “believes” in regards to the relevance of the RO (i.e. it’s an opinion and wasn’t specifically mentioned in the RTF by the FDA).

“In addition, the Company believes that receptor occupancy may be of marginal relevance given other clinical findings regarding dosage and is and will concurrently continue its discussions with the FDA on this issue.”

https://www.cytodyn.com/investors/sec-filings/all-sec-filings/content/0001193125-21-091607/filename1.htm?TB_iframe=true&height=auto&width=auto&preload=false