RE:Anybody read up on Adcomm Did you check out my post last night and the linked article? Here is the first thing of note in it. I think that this bodes well for our chances. I have been a little nervous about not meeting the primary endpoint and the single trial etc... this article has lowered my nervousness by half. :)
Key Article Points:
1. Accelerated approval by line of therapy We found a noticeable pattern in the way the accelerated approval pathway has been used in the past decade: All but one (21/22) of the new drugs entering the market that received accelerated approval were indicated for second-line or later therapy (Fig. 2). In contrast, 70% (14/20) of supplemental indications were for first-line disease.