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Biotech / Medical : Depotech(depo)
DEPO 7.300+1.7%Aug 14 5:00 PM EST

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To: biao luo who wrote (636)12/22/1997 2:58:00 PM
From: Czechsinthemail  Read Replies (1) 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
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