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

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To: JCS who wrote (864)11/16/1998 10:28:00 PM
From: Rudy Saucillo  Read Replies (2) of 887
 
Several things were different this time. Number one: the application and subsequent ODAC recommendation is for *accelerated approval* which has different standards than regular *approval*. Secondly, the efficacy data for DepoCyt in lymphomatous meningitis was clearly no worse than and likely better than the control, ara c, irrespective of how the data was subgrouped and analyzed. Thirdly, DepoTech did an excellent job demonstrating that DepoCyt side effects, while more numerous than ara c, were generally mild and transient. Excellent day for DepoTech. I was at the panel and would like to commend Dr. Stephen Howell (DepoTech's Acting Medical Director) for an extremely effective, rigorous presentation of DepoTech's data. Rudy
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