I don’t agree with the FDA being the problem. If we had the numbers needed for efficacy of our trial we wouldn’t be denied. Our trial wasn’t designed properly to succeed and our chance to change our primary end point flew under the radar of the review of the DSMB who had our future in their hands and told us we would succeed and to continue with that 42 day addition to our end point. Even though that had no meaningful ending for us if used. We have learned some expensive lessons.
We can’t blame the FDA for results that for many reasons didn’t make the grade of acceptance for a BLA or even a EUA so far. All hope of the EUA is still possible and maybe just needs a few more patients to reach the predicted 70 needed patients to have an effect on the trial efficacy in a few areas that allow us to achieve that EUA. All is not lost yet. We have those equalizing stats in the 55 patients so far according to Nader stating we had a 16.7% mortality in that group. We just need another 15-20 patients and 28 days then we send those results forward and see if we qualify for the EUA.
This seems like what is happening from my view. We sure are not in a hurry to get more trials started. The waiting game starts to look intentional for Cytodyn and even the FDA. Maybe to see if we can add the additional patients to our CD-15 trial because our trail size was so small. I for one, Can’t wait to see if it’s true that the FDA will add the extension to our critical section of our trial and get the EUA.
Definition of extension is what? It’s what I expect to happen if a extension is granted.