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Re: gfp927z post# 1411

Tuesday, 10/10/2006 10:35:13 AM

Tuesday, October 10, 2006 10:35:13 AM

Post# of 57986
davidal,

For long-term investors, the FDA clinical hold may hold a silver lining: COR has now established closer communications with the FDA and has brought in consultants it can lean on in future dealings with the FDA. I think this is no small matter. Furthermore, the FDA taking a closer look at COR's Phase II studies is in line with the McClellan/Gottlieb/von Eschenbach "Critical Path" strategy for the smaller-cap (They don't say this explicitly, but if you've read the working papers on the "Critical Path," it seems more attuned to the needs of the small-cap, development-stage biotechs who sorely need the critical path guidance.) development-stage drug companies. These communications with the FDA and the expertise brought by the consultants could prove very helpful down the line as COR advances its drug development in CNS, a notoriously difficult division within the FDA. (I'm sure Neuro can attest to this with myriad examples and references to his buddy, Rusty Katz.)


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