Yes, they promised the trial then and delivered. From what we know, the PE was met. Looked like LL did work.
Then they promised to submit the BLA and did so. But they botched it and FDA returned an RTF.
This time around, they are again promising the BLA submission. But it is not the "same thing" as years ago. They made the mistake and this time it is correction; probability that it is done correctly now is very high because the care to not have a repeat failure will be proportionally high.
It is like a student submitting his final class project in order to graduate from high School. The teacher returns it saying it has spelling errors, typos, wrong font size, no TOC, etc. The student has the option of failing school or fixing the mistakes. He wants to graduate no matter what, and proclaims that the errors are correctible and says he will fix and resubmit.
If you think that student really doesn't care and just wants to make his family think he is working hard so that they support him financially etc., then you can point to the past failure as some fundamental character issue in the student that will likely repeat. i.e. Don't trust him this time also.
However if you believe the student really wants to graduate, then you can be confident that the second-time around is going to be very different with the way he focuses and fixes all the issues the teacher pointed out.
I am confident that Cytodyn is the second type now. What happened with the first BLA will not repeat. They will fix the errors and get it right. I also believe they have developed positively in their communications with FDA. Dr. Recknor mentioned this fact; it might have been in the context of LH but chances are he would have communicated likewise with FDA with regard to BLA resubmission. Read: toxic relationship could have improved since then (even if not between Cytodyn investors and their reading of FDA actions against them). So, on that front also, I would think we are in no way comparable to the less mature company of the previous occasion.
All that does not mean that LL will get approved for HIV. Ultimately we have to win in the contents and all we know is that FDA has not addressed this question formally. Except for the ROT requirement. How central that is to the final decision, we have no way to tell. Perhaps Dr. Recknor can present enough data and add further justifications to go around any inadequacies in ROT data, and that is why the team is going forward with confidence. At this point the investor has to trust this much and let it play out. Don't imagine a new management will create magic when the data is what it is.
As for the apparently more substantial data that is the phase 3 trial results, we have to trust that we met the end point and FDA will not fault the contents of the BLA in that regard. Changing management is not going to change the trial results, and the right course of action is to have the FDA look at a properly submitted BLA and come to its conclusions on the results. Now is not the time to be pointing to the past and screwing the potentials right before us.
