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Biotech / Medical : XOMA. Bull or Bear? -- Ignore unavailable to you. Want to Upgrade?

To: Tharos who wrote (6394)	6/1/1998 11:43:00 AM
From: Edward Paule	Read Replies (2) \| Respond to of 17367

>>> the FDA not stopping the Neuprex Meningitis trial early <<< Neuprex was granted Subpart E designation and allowed to proceed directly into a phase III pivotal trial after a successful open-label phase Ib (or IIa?) trial in Britain. My question, how much weight does this open-label study have with the FDA when it comes to proving efficacy? If the answer is very little, then it makes sense why the current pIII trial was not halted at either of the two previous DSMB meetings. Obviously, there's lots of data indicating Neuprex's safety. But if the phase Ib data is disallowed, and there was no blinded phase II trial, then the current phase III trial provides the only source of efficacy data to the FDA. How would it look if the DSMB said stop the trial and the FDA said you didn't collect enough data? This line of reasoning goes hand-in-hand with the following observation. If the trial is planned to end in December, why did the DSMB recommend another interim analysis in September? Answer, in a September review, there will be over 200 patients who've completed the trial (not just enrolled, but completed the follow-up period). 200 patients was the initial plan for the entire trial. The DSMB knows that the FDA believes 200 patients represents ENOUGH data. Thus, IMO, the trial is going extremely well, the DSMB wanted to stop it last time but didn't want to take the chance with the FDA. So they recommended another review in September, because their conscious wouldn't let them kill any more kids than was necessary. If the DSMB wasn't planning to put an early stop to the trial in September, then why did they bother recommending it? I will now take off my rose-colored glasses and go to lunch,