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

To: James Silverman who wrote (749)	3/5/1998 8:35:00 PM
From: Dr. John M. de Castro	Read Replies (1) \| Respond to of 887

Hey Jim, welcome back to the thread. Thanks for the comments. The thread works best when there are different perspectives. I have to take issue with one of your points. I have the protocol for the phase III trial and it calls for intrathecal administration of both DepoCyt and methotrexate. I've also looked up the PDR entry for Methotrexate and it calls for intrathecal administration for this indication. Methotrexate is often injected i.v. for other indications. But, for metastasized brain tumors, you have to administer it intrathecally to get at the cancer. I appreciate your insight from having attended the hearing. I don't have that perspective. I've corresponded with others who were there and they concur with your judgement that DEPO did a lousy job. The heads that rolled at DEPO following this debacle probably deserved it. I can't wait to see the transcript. Does anyone know if it is out yet? DEPO has consistently held to the story that they have had great difficulty recruiting subjects and administering the protocol to the leukemia and lymphoma subjects. I have no evidence to confirm or refute their contention. However, it is hard for me to believe that the FDA would have approved a Phase IV trial as early as they did, a very unusual move, if there was a major problem with either the protocol or the use of solid tumor subjects. This is one of the troubling things about the DEPO picture. There are inconsistencies and contradictions that don't add up to a clear conclusion. If DEPO and their data were as bad as everyone reports from the ODAC hearing, why did the FDA approve a Phase IV? Why did PNU agree to buy the non-US rights? Why did Chiron help them and let them go ahead with the NDA submission? Why haven't Chiron or PNU bailed out since the hearing? If anyone has the answers, I'd appreciate hearing them. John de C