Cytodyn Inc (CYDY)

[Chuckles759]

I heard that it was not a drug related RTF - more of a paperwork issue.
The trials do not need to be performed again.

There are two choices:

1) Resolve paperwork issue and resubmit. Clock restarts and CytoDyn pays +$2M filing fee again.

2) Request the BLA to be filed under protest. This goes into uncharted territory for me.

At least one thing was confirmed to me - the true BLA submission date for the timeline was 11 May.

More wonderful reading opportunities:
https://www.fda.gov/media/87035/download


From the CDER document:

Filing Decision:
There are three potential decisions:

1. File the application – If there are no major omissions of data or other identified major deficiencies, the application is fileable. The
applicant is expected to rectify any minor issues.

2. Potentially refuse to file the application – If the application has deficiencies that appear to be correctable, the review team can work
with the applicant to rectify them. If the deficiencies are resolved, the application is filed.

3. Refuse to file the application -- If the application is incomplete on its face and the deficiencies cannot be rectified readily, an RTF
should be considered. Missing information is judged against the regulations detailing the requirements of an application and the
grounds on which an application can be refused for filing. (See circumstances outlined in Appendix B.)

The signatory authority has the responsibility for making the final filing decision.

A refusal-to-file decision ends the review process. The applicant’s options are to resubmit the NDA/BLA with the deficiencies addressed (the
resubmission is considered an original new application) or to request that the NDA/BLA be filed over protest. PDUFA V “Program”
applications that are subsequently filed over protest are removed from “The Program” and become subject to the standard 6- or 10-
month review clock, as applicable. The applicant must be notified of a refusal-to-file decision (via RTF letter) within 60 days after the
original receipt date of the application.