IPIC Message Board - Msg: 2837926

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Biotech / Medical : IPIC

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Aug 15 3:35 PM EST

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To: Scott Pratho who wrote (905)	11/29/1997 4:59:00 PM
From: NeuroInvestment	Read Replies (2) of 1359

A number of people, including myself had expected IPIC to file by the end of October. However, this was predicated upon the anticipation that Janssen was going to have an Advisory Committee hearing for its stroke drug, lubeluzole, at the November CNS AC meeting. IPIC was interested in getting its NDA filed first, for PR reasons. However,Janssen pulled its drug from AC consideration because its data was so weak, they are now conducting a very large supplemental Ph III. This took the time pressure off IPIC. Keep in mind that October would have been a monumental task to complete,with some risk of missing something....officially IPIC has always said it aimed to file by year-end, and they have taken a little extra time to make sure there are no loopholes or flaws, that their NDA file (which likely runs several hundred volumes) is as bulletproof as possible. I would not be surprised to have the filing within the next two weeks. NeuroInvestment

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