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Re: IgnoranceIsBliss post# 231127

Monday, 12/02/2019 10:32:42 PM

Monday, December 02, 2019 10:32:42 PM

Post# of 429260
Tasty, good find, but I went back and checked and these are all orphan drugs that were fast-tracked. I'm not saying at all that V can't or won't get early approval before the PDUFA date, but I don't think we can infer anything from the early approval of the five drugs mentioned in the article since they are all orphan drugs and V is not an orphan drug. That difference matters since orphan drugs get very preferential treatment.

Here is one among countless articles that gives a good summary of orphan drugs and ways they benefit from that status, as well as a controversy that has been brewing over that status:

https://catalyst.nejm.org/time-reform-orphan-drug-act/
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