it must be a little bizarre from the FDA's perspective. Cytodyn completes a pivotal combo trial and a investigational mono trial, submits everything for efficacy, manufacturing and safety from both trials and wants the FDA to approve everything is correct. But, cytodyn has no plans to file a BLA making any of this result in a drug on the market. I would think the FDA is not sure what the point is.

Obviously we know the point is to get the clinical hold lifted and so the safety data can be used for future indications. But, once this is all corrected, what is really the difficult obstacle to getting a BLA filed? Maybe the trial data does not match up with the original protocol so it looks like a result that did not follow the protocol? maybe this is why the FDA needs a new protocol submitted so what was meant to be trialed and what was trialed matches up?

Is the idea is that the FDA might get cytodyn to peace the trial back together beginning, middle and end that The FDA would approve it, based on the new protocal? If i was cytodyn management would I disclose this plan especially if it might still lead to no BLA or approval? could it be that not even bringing up this possibility is the safe route?

I doubt there will be an HIV approval in the near future, I think this is what is needed to have a safty data set fit into some trial protocal so it can be used in future trial protocals. what ever was a red flag is being fixed/explained so the hold will be lifted.