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

To: techbull who wrote (788)	3/31/1998 2:14:00 PM
From: Biomaven	Read Replies (2) \| Respond to of 887

The transcript of "The Meeting" are now available at the FDA site: fda.gov (you have to chase down some links to find it - 1997, CDER, Oncologic, the first Dec 18 transcript). I haven't had a chance to read it thoroughly. At a quick glance through, it is clear that a big part of the problem was that in hindsight this just wasn't a good indication to base a NDA on. Too few patients, no clear measure of response (you're basically just delaying how long they take to die), complicated patients who've already been through the mill, potential side effects that can't easily be disentangled from the disease itself. Proving equivalence with another treatment that doesn't work very well (and that the committee members are clearly skeptical about) just doesn't carry much weight. Basically I think this committee felt that, given there were some more studies for Depocyte waiting in the wings, they didn't feel too bad renouncing the earlier FDA-approved design of this study. Looking forward, it seems clear to me that this committee was open to the lymphoma/leukemia studies - the subtext that I read was "come back when you've got some studies in a simpler indication." Paradoxically, if those studies weren't around, the committee might have been more open to approving it immediately as a kind of "last resort" drug. As it was, they probably figured that the drug will get another bite at the cherry sometime this year. Some nuggets about the lymphoma study: 90% enrolled, fewer dropouts in the Depo arm than the comparison. Enrollment in leukemia arm was slow probably because of "restrictions." The whole thing reminds me of what the FAA terms "a controlled descent into terrain." A whole series of misjudgments or errors by the company, the FDA, the centers performing the studies, as well as the people presenting at the meeting itself, served to fly what is probably a pretty good drug into a mountainside. I actually feel a bit better about future prospects now that I've read the whole transcript. Peter

To: techbull who wrote (788)	4/1/1998 1:44:00 PM
From: StockDoc	Read Replies (3) \| Respond to of 887

Dear chani, you wrote "Dr Kim (if that is who you are talking about) also left". Well, his name is not Kim. He is Howell, the one that, someone wrote "taught ODAC", has always been the medical authority for DepoTech, has always been on its Board reviewing the really big things several times a year (like an NDA). And he IS the Medical Director (check, again records), although he holds his university position tight (just in case?). He and Chiron's Cowens (the other MD) were the ones who failed to convince, indirectly or directly, even 1 out of 10 of their quite knowledgeable oncologist colleagues that DepoCyt would benefit patients and they should prescribe it when they see a someone with carcinomatous meningitis. It really does not matter who runs the clinical trials. That's a routine job, you don't need an MD for that. The medical opinion on the drug is what ultimately matters. Convincing the drug advisory committee is the most important if not the single role of a medical director. Like the brain surgeon who makes a single cut. Everything else is done by the supporting team. But that cut is life or death, and the purpose of the whole process. Depo and Chiron probably tested Howell and Cowens and found Cowens better for this crucial task. Regards, StockDoc