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Biotech / Medical : IPIC -- Ignore unavailable to you. Want to Upgrade?

To: HumbleHarv who wrote (996)	1/25/1998 2:58:00 PM
From: NeuroInvestment	Respond to of 1359

1)The FDA responded quite quickly with a confirmation of 'expedited' status, which is encouraging. The next hurdle will be whether or not they will require an Advisory Panel. Because of the skewing of patient populations that complicated the analysis of both Phase III trials, the conservative expectation is that one would be called, perhaps for late Spring. The fact that Paul Leber seems less inclined to mandate AP's when he is comfortable with a drug candidate (e.g. recently, Cephalon's Provigil) and he is quite familiar with citicoline/CerAxon, leaves open some possibility (40% perhaps) that the FDA will skip the time and expense of an AP meeting. Thus best case for approval might be May, most likely middle-road timing would be mid-summer, worst case (they take all six months to decide they want an AP, which is unlikely) would be for mid-late fall approval. 2) Investor response to CerAxon success will have to be coupled with what I expect to be a sequence of study unveilings (from February to May) that will reveal the Redux cloud to be much smaller than had been thought. Full resolution of the Redux issue does not have to occur...As worries regarding Redux are calmed (and indeed there have been a number of recent comments from cardiologists screening Redux patients on their own that they are simply not finding much valvular pathology) the market will then be more responsive to the next story...CerAxon. Bucindolol and pagoclone will also provide important trial results during the year. 3) In the January issue of NI, the end-of-year target for Interneuron is 35. I see no reason to change that in either direction at this point. NeuroInvestment www.neuroinv.com