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

To: biao luo who wrote (636)	12/20/1997 6:42:00 PM
From: Andrew H	Respond to of 887

>>The difference between "intend to treat" and "evaluable" cost the company this failure and a surprising financial loss to shareholders. I don't think CEO gave us a satisfactory explanation. He was a little irritated and said they chose evaluable patients based on some predetermined critria. But why were there 7 not evaluable in the experimental group and there was only 1 in methotrexate group? Was that because of increased toxicity and side effects? He didn't give a detailed explanation and this would cause some suspicion that cherry picking of the patients was involved. That kind of irresponsible and argumentitive attitude is worrisome. << More good points, biao. I would caution all investors not to put any more money into this company until these questions are answered to everyone's satisfaction.

To: biao luo who wrote (636)	12/20/1997 7:19:00 PM
From: Cymeed	Respond to of 887

Another excellent post, Biao. Thanks a lot. One question asked during the conference call was the Q & L data (Quality of Life Data - I assume it refers to the average dates of survival). Dave Thomas (?), who is the one made the 45 minutes presentation during the ODAC meeting, said he did not mention these data (??? !!!) because he thought that the data were in the application. And the data was likely geting lost in the discusion. Obviously the company just did a terrible job in presenting their case ! They had no strategy, no analysis, bad preparation, under estimate of the difficulty of the approval process, and the consequence of such a rejection. I too am worried about the argumentative attitude of management. Hope their follow-up study will use the "intend to study" approach which is more conservative, instead of "evaluable." And it might show a surprise either way. For now, I am very eager to learn the details of the ODAC meeting. I like to know the bad words as well as the good ones the panelists have said. I'd appreciate very much if someone can post the details or a link as soon as they come out. BTW, I am holding many shares of Depo bought @ average price of $14.

To: biao luo who wrote (636)	12/22/1997 2:58:00 PM
From: Czechsinthemail	Read Replies (1) \| Respond to of 887

biao luo, Thanks for another excellent post. I agree that the leukemia and lymphomas comparisons should be more favorable to DepoCyt both on efficacy and side effects profiles. Perhaps even more significant may be the additional solid tumor studies, which may help make the statistical case when added to the previously submitted data. AS it was, even using the "intend to treat" analysis, DepoCyt's efficacy seemed to be somewhat better than the methotrexate control group. Hopefully, more numbers would further substantiate that benefit. I, too, would like to know the story on the "intend to treat" and "evaluable" differences. Erickson did seem upset and suggested that the ODAC committee had reneged on previously negotiated understandings with the FDA. Since I don't know what those agreements may have been, it is hard to evaluate his response. Maybe he felt justifiably angry and betrayed and was trying hard to contain it. I can certainly relate to that feeling. Baird