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Biotech / Medical : Depotech(depo) -- Ignore unavailable to you. Want to Upgrade?

To: Dave K who wrote (827)	7/2/1998 9:16:00 PM
From: StockDoc	Read Replies (1) \| Respond to of 887

Although you did not ask me, wandering around here, I'll try to give a shot at your questions (John might be busy): " If DEPO and their data were as bad as everyone reports from the ODAC hearing, why did the FDA approve a Phase IV?" FDA's function and role is not approving trials. Once an IND is active, a company or physician can do whatever trial they please to. FDA approves drugs based on good data from clinical trials. " Why did PNU agree to buy the non-US rights?" This we will never know, unless PNU's licensing division confesses that they did not have their medical affairs look at the primary data. I can't see another explanation. " Why did Chiron help them and let them go ahead with the NDA submission?" Chiron been there done that. Poor professional judgement, not the first, probably not the last (by the way, they badly need a new drug). "Why haven't Chiron or PNU bailed out since the hearing?" I don't think we know their current involvement. Chiron might not pay DEPO for clinical trials any longer; this hypothesis is supported by the company's new pipeline that does not list DepoCyt (see press release). In other words, Chiron might have already bailed out by not paying. As of the PNU deal, they probably took the risk of an upfront payment and that's all. Milestones and royalties are probably tied to regulatory approval and marketing, as usual in these corporate deals. Since these last two are unlikely even in Europe, PNU might, in effect, be out. Best regards, StockDoc