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Replies to #95267 on Biotech Values
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drbio45

05/05/10 11:39 AM

#95276 RE: DewDiligence #95267

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.