BREAKING: FDA Advisory Committee Votes 10 to 5 AGAINST Merck’s New Indication

I get the sense that most observers in the room were. . . stunned.

And, as I just wrote below, the full FDA Commission is in no manner bound by this Advisory Committee vote — but it certainly stretches the odds on a new label in Merck’s favor, any time soon — as a result of IMPROVE-IT data.

I have only more questions — none of which will be answered until the full Commission votes next month.

So, I’ll leave you with Larry’s fine commentary — on this busy, and quite strange, day in the FDA kingdom:

. . . .12/14/2015 15:36 — Boy the whole ezetimibe saga is amazing. Someone should write a book about it. . . .

That, my friends is a captial suggestion!

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