IDPH--Positive preliminary results for pivotal trial of ID Message Board

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Biotech / Medical : IDPH--Positive preliminary results for pivotal trial of ID

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To: contrarian who wrote (1369)	11/25/1997 7:00:00 PM
From: Pseudo Biologist	of 1762

C, I pass on the TA. The FDA announcement does seem overdue. This is what I heard thru second- and third-hand sources, so please take it for what is worth (probably not much). The FDA is not happy with the lot-to-lot consistency of material manufactured by IDEC. However, Genentech-produced material is good, there is a lot of it, and is ready to go. Still, the normal protocol would be to start launch with IDEC material because that's what was used in the trials. If the consistency problems cannot be taken care of quickly, plan B is to go with the Genentech material (which was planned to be used later on anyway). The delay is frustrating but not a huge deal in the general scheme of things. I have not confirmed the accuracy of the above or individual pieces thereof. Since you said "all inputs are welcome" here it is. I would welcome other inputs as well, even if (or especially if) they contradict what I say above. Regardless of what's holding things back, it may be a point where you will see pressure from physicians' and patients' groups to get this drug in the market soon. PB

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