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Biotech / Medical : momo-T/FIF -- Ignore unavailable to you. Want to Upgrade?

To: Robohogs who wrote (3072)	9/14/2005 6:18:02 PM
From: Icebrg	Respond to of 12215

They (i.e FDA) will have to ask the two guys who voted yes, I suppose. And avoid any communications with the thirteen who voted no. It is difficult though to see how FDA is going to be able to go against a 13-2 vote at ODAC. If Celgene has any ideas on this subject, they would of course have brought those to the light during today's meeting. Erik

To: Robohogs who wrote (3072)	9/14/2005 6:48:25 PM
From: former_pgs	Read Replies (1) \| Respond to of 12215

I have to admit that the Celgene situation is confusing. If Celgene is talking about labeling, maybe they're going to be working the FDA so that the agency accepts the current dosing as a starting point but includes strict guidelines for dose attenuation or interruption as a result of the side effect profile. Kind of a STEPS program, but for quick reduction of Revlimid dose... another inconvenience for Celgene in exchange for getting the drug on the market. Maybe they're going to be the first company around that negotiates outright for a black label ;-) Tough call. But I still think the valuation is pretty high right now.