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Biotech / Medical : LIPO-Liposome

LIPO 0.350

-4.4%

Nov 7 9:30 AM EST

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To: Puck who wrote (807)	9/13/1999 2:49:00 AM
From: Puck	of 900

A Radical Critique of Avalon's Position from the LIPO thread on Yahoo by Bezagre: ODAC PANEL... by: BEZAGRE 3445 of 3451 After reading Avalon's litany of reasons at to why they believe EVACET will not get regulatory approval, I read for hours the transcripts of the June 7th ODAC meeting of which Avalon bases their conjecture. The panel meeting involved discussions by all members to help determine supplemental endpoints for determining efficacy of cytotoxic drugs for treatment of metastatic breast cancer. They discussed time to progression and overall survival. Avalon states: Evacet is not a "new drug": It is a conventional chemotherapeutic agent that has been designed to be delivered differently. Since it is not a new drug, we predict that ODAC will want to make sure that EVACET approval will make a significant improvement to the current arsenal of drugs. In light of the fact that EVACET does not improve efficacy or lead to a clinically significant decrease in cardiotoxicity, we doubt that ODAC will approve EVACET as a front line therapy. As far as the cardiotoxicity aspect of their statement, Michsal did an excellent job in his "debunking Avalon" posts which I do not need to add to. Avalon obviously did not read the same transcripts that I did. The following are direct quotes taken from the June 7th ODAC panel meeting made by different members of the panel. 1.) "A favorable effect can be superiority to a control or equivalent to an effective standard regimen." 2.) "Survival is the net effect of death from both tumor and drug toxicity. Actually, for this purpose a survival effect is not necessary. We only want assurance that the new treatment is not worse." 3.) "Whether the endpoint is time to progression or survival is really irrelevent if the quality of life is so poor that it is meaningless." 4.) "The primary aim of cancer treatment is prolongation of life, but demonstration that a new agent causes tumor regression and improves patients clinical condition also supports approval of a new agent even in the absence of improved survival." These quotes do not back up any of Avalon's remarks.

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