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

To: chirodoc who wrote (594)	12/19/1997 11:51:00 AM
From: Czechsinthemail	Read Replies (1) \| Respond to of 887

Just got through listening to most of the conference call. A number of points were raised that seemed to suggest the major problem was small numbers making it difficult to make the case for statistical significance. Apparently, the ODAC committee did not go along with an agreement the FDA had made with DepoTech that smaller numbers would be allowed because it is a life threatening disease, hard to get larger numbers, etc. DEPO management seemed convinced that DepoCyt provides significant benefit that the data tend to support and larger numbers would presumably confirm. They will be holding discussions with the FDA concerning what further data would be necessary to establish adequate statistical support for approval. Possibly adding data from the Phase IV study. There was some discussion of the possibility that they might be able to get a provisional approval without or before another ODAC meeting. One interesting point concerned the side effects profiles. The chemical arachniditis refers to a general toxicity that is common to all chemotherapy agents. They felt there might have been a problem related to the open labeling that could draw more attention to any reported side effects on the new drug regardless of how serious and that these might be overlooked somewhat for methotrexate. They emphasized that the serious side effect profiles--1 death and 1 CNS infection--both occurred in the methotrexate group. They felt the failure to distinguish serious adverse effects from total adverse effects may have muddied the side effects discussion. Going forward, there seemed to be a sense that they would be announcing results on the lymphoma studies by next summer. Also, they expect Phase II results on DepoMorphine by midyear. And they indicated there may be some partnering with Synthelabo, Monsanto and perhaps others around new compounds. Overall, I came away with the sense that there was a fairly good likelihood that DepoCyt would be approvable given more data to support statistical significance. The biggest sticking point seemed to be the small numbers problem, and if they are able to add more data it will presumably be resolvable. Side effects I think is a non-issue--it seemed significant in the committee vote primarily because of the lack of statistical significance from the small numbers. I'm planning to hold on to my shares and wait for the smoke to clear. I think we'll get a rebound from here, particularly after FDA discussions provide a clearer sense of the steps toward getting adequate statistics. Baird