Cytodyn Inc (CYDY)

[stockorus]

I think your reference is the May 24 filings of SEC and Cytodyn's response.

My take:

The later issue was whether Cytodyn can state "safety and efficacy" based on their own analysis of data and due to the fact that FDA did not raise questions regarding them in their meetings with the Company or in the RTF. Cytodyn is clear that the FDA's focus during the meetings or the RTF was not on the Science of LL with regard to safety and efficacy but on other data-devise related issues etc. However Cytodyn assumed and stated based on its own analysis of data that the safety and efficacy were clinically proven and that the lack of questions from FDA in this regard meant they were also in agreement with the science being clinically proven in the trials and only wanted additional and subsidiary data to complete the picture.

If the FDA had any doubts on the science when they looked at the trial results, surely they would have addressed or mentioned of them in the RTF. That is the logic. For example, if the results give the right p-value and hit the agreed-to primary endpoint for establishing safety and efficacy, then technically the science has "clinically proven" the conclusion. So Cytodyn may take that as sufficient basis for making such claim given that FDA also did not question this part.

SEC basically disagrees with this and has told the Company that they cannot assert safety and efficacy as clinically proven until FDA formally posits the same. Cytodyn has since agreed to change the language used henceforth and SEC has accepted the filing.

As far as Cytodyn is concerned,

1. Our analysis of data shows ("we believe") safety and efficacy. But we cannot formally state the same as clinically proven since FDA has not yet confirmed formally.

2. In the RTF and meetings, FDA never questioned the implications of the trial results with regard to safety/efficacy, never cast doubt on these conclusions.

3. FDA however wanted more data, better presentation, etc. all of which Cytodyn believes can be done and is presently working to accomplish.

Nothing further to this. We are on track.

The deficiencies cited by the FDA in its July 2020 Refusal to File letter consisted of administrative deficiencies, omissions, corrections to data presentation and related analyses and clarifications of manufacturing processes. None of the deficiencies cited related to the FDA’s questioning the science, leronlimab’s clinically proven safety and efficacy or the Company’s ability to manufacture leronlimab at commercial scale consistent with cGMP standards. Management is working with new regulatory consultants to effectively cure the BLA deficiencies.

the issues related to clinical and statistical data, and device related issues, are the result of curable presentation issues and omitted data in the submitted BLA. Indeed, many of the noted missing “device related issues” were contained in the original BLA, as confirmed by the FDA in subsequent correspondence. The “chemical, manufacturing and control related issues” were standard FDA review requests which were subsequently resolved post-BLA submission through written communications with the FDA and will be included in the BLA resubmission. These deficiencies and standard FDA review requests did not call into question the science, leronlimab’s clinically proven safety or efficacy, or the Company’s proven ability to manufacture leronlimab at commercial scale in full compliance with cGMP standards.