Agree with Xena. We may discourse about the level of efficacy in out P2 but, if we have only "6" that show a significant response, we have a blockbuster. And if the the remaining 19 are responding better than the current SOC all the better. We need to look at the number of drugs that are approved and are a commercial success while only treating only a small portion of a patient population. If one goes back and looks at the new FDA modus operendi as stated by Gottlieb and Woodcock you will see articulated, adaptive "in silico" trials focused at developing drugs and combos successful at treating a number of wide and narrow sectors of a disease.
I believe as we post, our SAB led by Tayo Fadiran, Adriana technicians and the folks from CDER are well on their way in coming up with a 21stCCA trial architecture which will be inplace in Melbourne before the end of the year.
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