Fouremm,

I wish I could help. I really wish I had this kind of knowledge about how the FDA works. But I have no experience in these matters. Masila's transcript of the June 30th RVX meeting (in link library) mentioned that RVX was changing or considering changing the FDA advisory committee that they were applying from "Endocrine and Metabolic" to "Cardiovascular and Renal." These are indeed two different advisory committees at the FDA. So does this indicate that they hit a wall with the FDA with the first committee? Seems to me that the "Cardiovascular and Renal" would have been the way to go in the first place with MACE being the primary endpoint, but perhaps the diabetic population emphasis steered them towards "Endocrine and Metabolic."

Regarding the change from plaque regression to MACE as the primary endpoint, and how the FDA would perceive the post-hoc analyses of ASSURE/SUSTAIN......great quesitons. I wonder these myself. Is there precedence for a failed phase IIb proceeding to a phase III trial? Are post-hoc analyses valid or does FDA require successful phase II to go to phase III? If Phase III is allowed in Europe and China, does the FDA acknowledge this as a valid Phase III trial for US drug applications? At least the drug has proven to be safe thus far, so RVX has that going for them.

I suggested to Sarah at RVX that they blog on this and she answered "Once the protocol for the upcoming trial is announced I feel many questions will be answered. Until then I cannot comment on specific regulatory discussions."

Best,

BearDownAZ