Replies to post #16919 on Cytodyn Inc (CYDY)

[BlackDoggie]

Edit: I see that I should have read ahead, and I would know that misiu already responded... I'll leave my post anyway.

They don't technically need FDA approval to unblind the data from the first 30 patients - but they may need FDA agreement to include the additional patients they've enrolled. I believe they're having discussions with the FDA to ensure that they're all on the same page with unblinding the data and including (or not) the additional patients to avoid any costly procedural missteps. I believe they'll have the data in hand long before the meeting in October, as my understanding is that meeting is intended to discuss BTD and a BLA, which would both require having the data in hand to discuss.

All of that is my speculation, except for the bit about not needing FDA approval to unblind the 30 patients that were agreed upon in the original protocol.

Misiu or any others with deep experience, please feel free to chime in if I missed anything here.

[Saltz]

The locking and unblinding of the Combo Trial will not happen until they meet with the FDA to reach agreement that the patient population has satisfied the agreed upon protocol in reference to the patient profile. Because the trial is small they will not take a chance on a misstep on this critical aspect of the trial. They are pushing for a meeting with the FDA prior to the scheduled Oct. 17th meeting. They feel they have satisfied the protocol but because of the severe nature of these patients illness they are continuing to enroll. They are very confident that PE will be achieved but they need the FDA to agree they have the correct patient population. If this were a trial with 200 patients they would not ask for this meeting- 30 is a small number.

Because the future of Pro-140 and our investment hinges on the outcome of this trial to open the pathway for approval they are taking a very conservative route. IMHO the bottom line is Tony is not going to give the FDA any wiggle room...he wants confirmation.

To bridge the gap to the needed catalysts to hopefully generate an organic uplist they are raising $15 million through Paulson. Offering is .75 and 50% warrants at $1. This is currently being subscribed.

Catalysts:

Combo PE Data
The green light from the FDA to submit BLA
The grating of AA and BTD by FDA

As I have said before a sweep in the above catalysts would be a home run. The strength of the PE data along with safety data from Mono is going to determine BLA, AA, and BTD. If we have to wait until Oct. 17 for FDA meeting that will push us into November to compile and PR PE data. Then the all important meeting with the FDA to find out if they are going to help expedite approval.

Once again my trust is in Tony to cross t's and dot i's. This is why he is calling the shots. This is his area of experience and expertise that is critical.