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

To: BD who wrote (757)	3/9/1998 12:02:00 PM
From: Dr. John M. de Castro	Read Replies (1) \| Respond to of 887

I participated in a DEPO conference call this morning. DEPO claimed that safety, including arachnoiditis (headaches) are no longer an issue with the FDA. The primary issue is efficacy. DEPO stated that the FDA wanted to focus on a few primary issues. These included the number of patients treated and the quality of life. DEPO has nearly doubled the number of patients submitted in the amended NDA including about double the number of lymphoma patients. They are also including more details about the individual patient quality of life experiences with DepoCyt including vignettes from patients. In regard to efficacy, DEPO indicated that the criteria previously used would still be used. This was an issue because ODAC questioned the end points that DEPO used. In the call, DEPO stated that the FDA were OK with the previously used end points. Importantly, in answer to questioning, DEPO indicated that the FDA would not be requiring that DEPO demonstrate statistical superiority of DepoCyt in comparison to Methotrexate. Although they did not say this, I came away with the impression that superiority needs to be suggested but does not have to reach the .05 level of significance. ODAC meets only twice between now and the July 28 cutoff date for the FDA to give a decision on DepoCyt. The first meetings agenda is set. It is possible that DepoCyt will be looked at again at the June ODAC meeting. However, DEPO indicated that the FDA has not indicated that they were going to require this. It was not said, but again, I came away with the impression that, it was unlikely that ODAC would be looking at this again. JOhn de C