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Re: lumpy9200 post# 47426

Thursday, 05/24/2007 8:52:43 PM

Thursday, May 24, 2007 8:52:43 PM

Post# of 252525
lumpy I'm sure there are others who have better knowledge to answer. I can tell you another reason for doing it based on many of the biotech I follow. That is the disease/indication just does not have a lot of patients to run a large trial would require years to recruit. BMRN/UTHR are two companies that I follow and their trials are < 200 patients. I remember TKT (pre shire) had a trial planned for their Gaucher product that they had originally hoped they could have their trial act as P1/2/3 (I don't recall how they were getting away with this) and the number of patients was in the 10-15 range if memory serves. I believe they had pretty much an understanding they could do this and then before they were ready to begin FDA said that would not be enough so it was just done as a P1/2 trial.

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