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

To: Czechsinthemail who wrote (612)	12/19/1997 4:42:00 PM
From: John Bloxom	Respond to of 887

I'm having a hard time finding any confidence in management at this point, Baird. How could they possibly be so disconnected from the thinking of the committee? This wasnt't a near miss; it was a miss by a mile. For me it raises questions. My questions aren't with the product but are instead with the product's management. What assurance is there that we don't have the old "great case/lousy lawyer" problem here? I 'm not saying that managment is lousy, mind you. i guess what I'm saying is that I don't know. Regards, John

To: Czechsinthemail who wrote (612)	12/19/1997 5:54:00 PM
From: seminole	Respond to of 887

Baird <<<I think DEPO management was confident enough in their product and their understandings with the FDA that they went into the ODAC meeting and got ambushed>>> I am sorry but as a little, replacable, worker bee; I expect more from management. First, in my opinion, you should never present the minimum work required because it leaves no room for error. Second, they damaged the image of their core product (Depofoam) by connecting it to a marginal cancer drug with marginal clinical data. Why do I feel that the cancer drug was selected based on who would make licenseing payments? Right now I still like the delivery system but I hate that cancer drug. richard

To: Czechsinthemail who wrote (612)	12/20/1997 12:20:00 AM
From: John McCarthy	Respond to of 887

<<I think that the disconnect between ODAC and the FDA people who negotiated with DEPO is the central problem. ODAC members apparently felt they had to uphold rigorous standards for statistical significance regardless of what the FDA had told DEPO. And lost in the side effects discussion was the fact that the two serious complications --one death and a CNS infection occurred in the control group. Again the problem is small numbers that make the results suggestive of benefit yet statistically insufficient. I think the results were encouraging enough to expect eventual approval.>> Baird - We are both at the same place in our thinking (I feel bad for you). Ah, there were effectively 3 important posts today - the key one being the reconciliation between DEPO's public interpretation of what they thought they had and the "rigorous" (thanks) standard the ODAC committee used. Now can you slow down for me so I can play catch up on two matters? (1) Is there a specific target end date (my terminology) for the completion of Phase 4 on NM. (2) Is there a specific target end date for the leukemia P3 trial? If this info has been posted, sorry to be a pest, but I missed it. BTW, at this time this sounds nuts, but I do know how to sell and take my lumps when its time to take my lumps. Depending on (1) and (2) above, I may buy in. I am trying to get a feel for the time horizons involved. Regards, John