Monday, December 14, 2015

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. Having said that, I don't expect much of a dip on the NYSE, come tomorrow -- as not much new revenue would have been expected by Wall Street -- even with a "yes" vote today.

And so -- 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 capital suggestion!

No comments: