Blafarm, If that memory is correct, I wonder if
Post# of 148187
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Posted On: 06/25/2020 9:50:23 AM
Blafarm,
Very valid question, my opinion is that, since we have a P2 and a P3, we should try and reinforce the results (if positive) of P2(M/M) with P3 (S/C).
Why? P3 interim "peek" will be over 50 patients and P2 over maybe 85-90. Both trials theoretically require either more patients or another phase.
We need an approval of some sort. If we can prove the MOA with both FDA will have a damn hard time negating it.
I am not sure which one will be given, and hope both, but certainly the release of two trials with positive results will boost each other. As far as the exact timing, I think that one (announcement) followed by the other with a few days difference will make the biggest effect on the SP: goes up with the first one and then "deep pockets" have time to think get ready and enter the fray after the second one.
Another discussion we need to have is price projections in this scenario (not taking into account HIV or Oncology or NASH). What would it be with M/M approved ? or C/S approved ?? Or both ???
Quote:
If that memory is correct, I wonder if there is a plan for CytoDyn / Amarex to process the results from both trials as they become available -- but present them to the FDA at the same exact time.
And that causes me to wonder if the FDA will issue the equivalent of a non-disclosure order, preventing NP from announcing the preliminary results from the first available trial (P3 S/C) to investors.
Very valid question, my opinion is that, since we have a P2 and a P3, we should try and reinforce the results (if positive) of P2(M/M) with P3 (S/C).
Why? P3 interim "peek" will be over 50 patients and P2 over maybe 85-90. Both trials theoretically require either more patients or another phase.
We need an approval of some sort. If we can prove the MOA with both FDA will have a damn hard time negating it.
I am not sure which one will be given, and hope both, but certainly the release of two trials with positive results will boost each other. As far as the exact timing, I think that one (announcement) followed by the other with a few days difference will make the biggest effect on the SP: goes up with the first one and then "deep pockets" have time to think get ready and enter the fray after the second one.
Another discussion we need to have is price projections in this scenario (not taking into account HIV or Oncology or NASH). What would it be with M/M approved ? or C/S approved ?? Or both ???
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