Replies to post #229762 on Cytodyn Inc (CYDY)

[janice shell]

Cytodyn has clearly had many problems with the FDA in recent years. However, it seems this letter from 27 April 2023, addresses at least some of them in a positive way:

The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter dated February 11, 2022. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA surveillance will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during subsequent surveillance or through other means...

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cytodyn-inc-626957-04272023

You can see other correspondence between the company and the regulator here:

https://www.fda.gov/search?s=Cytodyn

[Monroe1]

Most likely yes, but then again the FDA has been a bit cranky in the past back two years ago when Nader was booted out. It's not like the FDA did not know what was going on with him and AmarX. So now they are helping with the protocol. Will they ask for more info? Probably. Will they approve the protocol? Of course.

Be that as it may, our new CEO Dr. Jay is well known and respected. He and others involved know the FDA and how to proceed. Many years of experience in the pharmaceutical field by our team will prove successful. Don't forget, leronlimab works and is safe. Does that bother you and your bosses? Surely it must as evident from your constant posting over the years. Hope it pays well.

$CYDY$ 2024