Cytodyn Inc (CYDY)

[MFGinvestor]

FDA Changes EndPoint Guidelines for Severe/Critically Ill COVID Therapeutics/Biologics on Feb 22, 2021

I found this information interesting and possible explanation of why Cytodyn did not release TLD and why they are talking with the FDA. However, make your opinion on these findings.


FDA Guidelines (sources)

May 11, 2020 guidelines:
https://issuu.com/greeley2/docs/fda_guidancecovid_19-developing-drugs


Feb 22, 2021:
Press release: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-policies-guide-medical-product-developers-addressing-virus

Updated Guidelines: https://www.fda.gov/media/137926/download[/url][tag]insert-text-here

Comparison
Quote:
- In a trial in severe and/or critically ill patients, examples of
appropriate endpoints could be
- All-cause mortality at an appropriate time point
(e.g., at least 28 days for hospitalized noncritically ill
patients,(footnote27) 60 days for critically ill
patients(footnote 28)

- Footnote 28
"C Karagiannidis, C Mostert, C Hentschker, T Voshaar, J Malzahn, G Schillinger, J Klauber, U Janssens, G Marx,
S Weber-Carstens, S Kluge, M Pfeifer, L Grabenhenrich, T Welte, and R Busse, 2020, Case Characteristics,
Resource Use, and Outcomes of 10021 Patients with COVID-19 Admitted to 920 German Hospitals: an
Observational Study, Lancet Respir Med, 8(9):853–862."

(This study seemed to influence the change)

The FDA has changed the guidance for endpoints related to Critically Ill Covid Patience on All-Cause Mortality from 28 days (May 11,2020) to 60 days (Feb 22, 2021).

Is it a coincidence that Nader issues a press release the same day the FDA updated guidance? I think this was intentional.

With this new guidance the CYDY CD12 Trial is in a gray area. The trial is concluded with data at 14 days, 28 days and 42 days (reco from DSMC). However, the FDA is reco/asking for 60 days of data for Critically Ill. I doubt that the FDA revised this guidance on Feb 19th and probably was pulling this together over the past month, the same time CYDY was ready to report.

Either CYDY was aware of these changes in early FEB (after Nader said TLD was going to be reported) OR FDA contacted CYTO to let them know (less likely) or CYDY went to share the unblinded data with the FDA first and they realized they had an conflict between the data collected and the new guidelines being developed. Maybe the FDA needed some time to provide guidance to CYDY on how to manage the data from the trial and path for submission.

This quote (IMO) makes a little more sense now. “We are eager to reach conclusion in our discussions with all the regulatory agencies for the path going forward and will release the details of our data and the results of our discussions with regulatory agencies in the coming weeks.”

You make your own decision, but did not see anyone talking about this point.

MFG