Wednesday, June 10, 2009

On Asenapine: the erstwhile Salmon offers improvements -- and corrections -- for which I am genuinely appreciative. . . .


Salmon, as ever, has done a more complete -- and thoughtful -- job of saying something I "would have meant to say", had I had it in me(!). Thanks!

Importantly, Salmon also was able to find, in the Federal Register yesterday (where I failed), the notice of the now tentatively-scheduled July 30, 2009 FDA Advisory Committee meeting to consider Saphris (Asenapine). His comment is here -- do go read it all; but I have corrected mine of two days past, based on his, thus:

. . . .Well Schering-Plough announced February 20, 2009, that the [Asenapine FDA] complete response was filed. The review clock on that is six months so the decision will [presumably] come mid-August 2009.

I just found the advisory committee announcement for the hearing on asenapine. It was in today's Federal Register and will be held July 30, 2009.

Today's advisory committee hearing [on pediatric indications for the latest class of FDA-approved anti-psychotics] was as I predicted, very misleading. . . .

Do go read it -- it is illuminating!

No comments: