Michel Vounatsos, Biogen CEO (Biogen via YouTube)

Damn the crit­ics, Bio­gen CEO Vounatsos or­ders full speed ahead on prep­ping a con­tro­ver­sial ad­u­canum­ab launch as FDA de­ci­sion looms

Right now one of the most in­ter­est­ing par­lor games on Wall Street is of­fer­ing odds on Bio­gen’s chances of get­ting an FDA OK on their con­tro­ver­sial Alzheimer’s drug ad­u­canum­ab.

For most ob­jec­tive play­ers, it looks about like a coin toss, maybe a lit­tle worse than 50/50, as the Street bal­ances the bull case of a full, mega block­buster ap­proval, a re­strict­ed ap­proval or a dis­as­trous or­der to go back to the clin­ic and mount a new Phase III. That last op­tion was clear­ly the guid­ance most of the out­side ex­perts in the pan­el re­view of­fered the agency, as the in­dus­try is still puz­zling out the ques­tion of whether or not the FDA is get­ting tougher in its over­sight of drug de­vel­op­ment.

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