Saturday, November 05, 2016 3:02:43 AM
The way I see it:
Mono injects first patient this year.
Adjunct completes enrollment Q1 2017.
Adjunct results are 5-10 fold better than protocol requirements in terms of viral load suppression for meeting efficacy.
Those results are going to expedite the enrollment of the balance of patients left to filll the Mono Trial and it will close quickly.
It is quite possible both trials could be fully enrolled by April of 2017.
There has been speculation about the number of patients in the Mono Trial. My understanding is Nader wants 300 patients because he wants the numbers to hammer home the safety and effectiveness of Pro-140 to the FDA, BP, and the HIV community-a small number of patients isn't going to get it done. Mono treatment is the the big play and he understands it's not a cake walk to disrupt and replace SOC. If this goes according to plan BP will be "trying"to cut a deal Q2-Q3 2017.
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