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

To: Czechsinthemail who wrote (725)	2/16/1998 2:23:00 AM
From: Dr. John M. de Castro	Read Replies (2) \| Respond to of 887

I wish I could predict the FDA's actions. I was certainly off the mark in predicting the ODAC results. So, I can only guess and probably poorly. I believe that DepoCyt will eventually be approved. But, the exact road to that approval I can only guess at. That being said, I have to believe that the FDA realizes that DEPO was very unfairly treated by ODAC. They were told by the FDA and a prior ODAC that what they needed to show to get DepoCyt approved was equivalent efficacy to Methotrexate. The present ODAC changed the ground rules without bothering to tell DEPO and refused to accept equivalency. They demanded a statistically significant improvement on an intent to treat basis. This presents a dilemma for the FDA; whether to be fair with DEPO and override their own advisory committee or be unfair to DEPO and go along with the ODAC recommendation. If I were them, I'd be looking for a politic solution. For example, taking the Phase IV data, that ODAC didn't see and use it as evidence of efficacy. They can then claim that this satisfies ODAC's criteria, and approve DepoCyt. I have no idea if that will be what will happen. I like to think that it is a reasonable hypothesis. John de C