Cytodyn Inc (CYDY)

[Cindylou822]

Yes. The FDA wanted the safety data reviewed across all studies and, I believe, all indications. Amarex specifically said they were maintaining and reviewing safety data. Nadar specifically said Amarex was withholding the safety data they needed for the FDA as a big reason they were suing Amarex for access to the database. Cytodyn was unable to complete the review of the safety data without that level of access to the databases so they could pull safety data from across studies and make sure there were no missed safety concerns. Drugs that target the immune system are notoriously prone to side effects. It's understandable why the FDA would want to be cautious about giving it to very sick, unhealthy people without that data. If you look back, that was the fight all along. Now it's being reviewed by a new pharmacovigilence CRO. It's been long enough imo, that if there was a clear signal of safety concerns, other studies would be put on hold. I think it's just about waiting for the process to complete. Could be any time now, but they may wait to give it to the FDA first