Hey Five Cent. I am just assuming. I did hear some gossip that a...

Hey Five Cent. I am just assuming. I did hear some gossip that a p3 was planned for next year, but just gossip, so no evidence. What I will say is a lot of the work in how to reach a correct diagnosis, for trial recruitment, must have already been done prior to the 201 trial recruitment. Hoping for a clear readout of 201 trial efficacy. Maybe they will not need a year for the FDA to review and agree on design for a P3 or P2/3 pivotal for approval..
The professional team David Stamler brings to this trial is also a plus, I think.
It depends on the trial protocol they cook up. My guess is only treatment naive patients will be recruited. Imagine if a partly healed patient from 201 ends up in the placebo and outperforms the drug arm. I guess 201 placebo patients could be eligible for the P3.
It will be much better if the 201 results are so good the FDA grants a conditional approval. The FDA does encourage, when there is no other treatment available, to open the P2 and continue it as a open label, so trial patients can continue treatment.
All just MYHO