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DewDiligence

10/02/06 9:57 PM

#967 RE: jessellivermore #966

>I have no basis to rebut your guess of 2013 as the market launch date for factorVIIa, but this seems rather gloomy estimate.<

Dr. Cox said 2009 was the earliest rhFVIIa could enter the clinic. Four years from the start of phase-1 to a product launch seems about right to include a realistic amount of time for enrolling patients, treating patients, analyzing data, designing phase-2 and phase-3 trials, preparing a BLA, and regulatory review. A gloomy forecast would IMO be considerably longer.
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shears

10/03/06 2:00 AM

#970 RE: jessellivermore #966

I've been trying to figure out why Factor VII is such a big deal. It must be good stuff or GTCB is stupid with this dilutional deal. GTCB is not starving for cash so on the suface they are bad negotiators or else there is more to Factor VII and whatever else the Fenchies offer than meets the eye. I think that the 92% 'off label' usage is the most telling statistic. Surgeons who operate on 'bleeders' want this stuff and they use it cuz it works for some reason. I'm trying to understand the extrinsic vs intrinsic pathway thing in the coagulation cascade but I'm not a scientist so it takes me a while to delve into this stuff but I think that's some sort of key to why this is a big deal. Scientists, please chime in or I'll google myself to death trying to read thru stuff that's way over my head. TIA.

Shears