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ARBITRARY & CAPRICIOUS

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ARBITRARY & CAPRICIOUS

Re: None

Wednesday, 03/27/2013 9:26:02 PM

Wednesday, March 27, 2013 9:26:02 PM

Post# of 97239
Any of the bio experts here care to explain the orphan drug rules. I thought that the target population could not be >200,000 lives. In the case of DARA, I understand the unmet need but the pain issue suffered by cancer patients is not a rare disease. Isn't this more of a fast track situation versus orphan. Have the rules changed or is my understanding incorrect?
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