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linhdtu

03/28/14 6:16 PM

#2849 RE: Solantey #2847

Unanimous positive vote for Adcom is not likely going to happen imo.

That said. Even a simple majority positive or 4/5 positive vote does not mean approval is a sure thing.

Then given approval, does not mean that partnership is or will be imminent.

It is obvious to me today from reading the details of the data submitted to the FDA by mnkd, why there hasn't been an announcement of any kind of a partnership yet. Or that until today, mnkd has only released the top line results from 171 and 175.

As usual, the devil is in the details.

However, as someone has reminded me, the fda is not in the business to forbid drug, just to make sure they are safe and effective, which is the case for type2.

Still the effectiveness results of Affreza in 175 is nothing to write home about.