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Biotech / Medical : CLTR COULTER PHARMACEUTICAL

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To: Gordon James who wrote (237)	8/18/1999 1:37:00 AM
From: Pseudo Biologist	of 666

Welcome aboard and thanks for a super post. A few extra factoids: (1) there is indeed a 45-day deadline to hear from the FDA. Anticipation of this probably accounts for the jump yesterday. Disappointment on the lack of an announcement plus short rumoring would explain the reversal. (2) as said elsewhere in the article you cite, the 45-day limit is internal to the FDA; Coulter indeed has not heard from the FDA either way yet. There seems to be a harder 60-day deadline (since submission of BLA) when Coulter would be notified that the application has been accepted. On hot versus cold, I appreciate your explanation. Yet, if you talk to the IDEC fans I do not think they are so convinced that there is such superior efficacy of Bexxar vs. Rituxan seen in these trials One issue often brought up is that of different standards used by the companies to define responses. I personally do not buy the latter, but I wonder if you have run into this or have comments. It also would be very useful for us to get an update from Coulter on what this hot/cold trial looks like thus far. The last release on this was in late 1997, if I remember correctly, and the results looked very encouraging. Why Coulter started this trial remains a bit of a mystery. It is however a very interesting science question to ask. Manufacturing of these agents is always an issue. Bexxar would be the first radio-immunotherapeutic up for approval in the US. I imagine there are a number of immunoradioconjugates used in diagnostics, and how those are or were handled may provide a clue here. Either way I think these things would be handled later, and the FDA would concentrate on efficacy issues first. Even "mighty" IDEC had a bit of a scare on manufacturing of Rituxan after the FDA panel meeting and very shortly before final FDA approval. I fail to see how this could be a show stopper at this early stage of the process. Yes, dramatic situation indeed; let's see what the next two weeks bring, ... and then some. Welcome again, PB

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