Replies to post #196559 on Cytodyn Inc (CYDY)

[The Dark KnaDDir]

Presumably before May 1st it was sent. The exact date is key because if they were sitting on the letter without telling shareholders or telling shareholders something else that is not a good look. Perhaps this is one of the things what the DOJ is investigating?

[Chuckles759]

Interesting on wanting to know what specific date the HIV-1 BLA (BLA 761144) was submitted....seems that a certain individual is also curious....

https://www.fda.gov/media/154586/download

This is from the "November 2021 FDA FOIA Closed Logs" which are FOIA requests submitted to the FDA that were completed and the reason they were closed. "Withdrawn Closed w/o Charges" means that the requestor withdrew their request and was not charged any fees by the FDA in the process of fulfilling the request.

So, what's a "Form FDA 356h" everyone asks?

FDA 356h form is the application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use. Applicant who want to submit BLA or NDA to USFDA need to file in the 356h form.

https://nckpharma.com/what-is-usfda-form-356h/

So, inquiring minds want to know...did the FDA say it was going to take "55 years" to respond? Or, was the FDA going to charge more than $5.95 to fulfill the request?

Well?