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drbio45

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drbio45

Re: DewDiligence post# 95267

Wednesday, 05/05/2010 11:39:05 AM

Wednesday, May 05, 2010 11:39:05 AM

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dew,

can you explain how the regulatory pathway for biogenerics helps. I think the new regulations hurt companies pursuing bio generics. The fda is asking for safety and efficacy studies. How do you recruit patients on a drug for a trial where the endpoint is that the efficacy is the same.
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