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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?


To: Biomaven who wrote (17764)9/7/2005 10:58:31 AM
From: Arthur Radley  Respond to of 52153
 
Add IDBE to the list of takeovers...GSK buying them!!



To: Biomaven who wrote (17764)9/7/2005 12:55:00 PM
From: tuck  Read Replies (1) | Respond to of 52153
 
I've looked at the briefing documents, and am generally impressed. In both types, the glycemic control looks OK versus what happened with ARDM's formulation. Thus the Type 1 data that I was concerned about looks OK except for one thing. A patient died apparently from hypoglycemic coma, grand mal seizure, and death (the verbiage doesn't say if the same patient experienced all of these events, and the table (#69) doesn't, either; I'm making that assumption). The cause was unknown, but considered treatment related.

The dropout rates and AE profiles look similar to SC, except for a small percentage of pulmonary events like cough, bronchitis, and the like, that didn't seem to develop into anything serious over time.

If it weren't for that death, I'd say Exubera passed with flying colors. As it is, I'd guess the panel will give the thumbs up by a clear majority and the FDA will follow suit (2:1 odds). No longer an Exubera bear. But not confident enough to go long, either.

Cheers, Tuck