Cytodyn Inc (CYDY)

[djjazzyjeff]

Neither. The receptor occupancy assay is trivial and any other company would have it done by now. The FDA is not slow walking anything and they are trying their best to deal with the incompetency in Cytodyn management. There is no conspiracy against Cytodyn just really lousy management and a questionable drug. The real issue is likely much deeper in the HIV data and is preventing a BLA from coming at all. I wouldn't be surprised if the BLA never gets resubmitted. The issues with it are likely well known in Cytodyn management and is why it took so long to submit in the first place and has had so many problems since. It's also likely related to Mahboob's leaving. When something doesn't add up, you're not getting the complete picture. You would do well to remember my wise words.

Here's another hint: they didn't submit that mock data on accident. The idea that they did is ludicrous. That mock data was left in to pull a fast one that the FDA caught. Whatever it was filling in for is likely the data that's preventing the HIV from ever crossing the finish line. This is my opinion but it is a very very informed opinion and I am one of the smartest posters here.