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Re: bradfor123 post# 806

Thursday, 04/03/2014 1:36:14 AM

Thursday, April 03, 2014 1:36:14 AM

Post# of 3833
Perhaps you should reveal "what evidence you have" that it will take 5 years for the FDA to approve a drug that already has Fast Track status.

Fast Track also makes the drug eligible for Accelerated Approval and Priority Review. There is also compassionate use. And the results achieved in the compassionate use program can be used to: support the NDA, identify new diseases or conditions for which the drug is efficacious, and/or inform/design future FDA trials. When the drug is proven safe AND efficacious in Phase 1, there is no reason not to get it approved for compassionate use. Once it is actually used to get people off that "death row" liver transplant list, I suspect thing will move pretty fast.

http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/SpeedingAccesstoImportantNewTherapies/ucm128291.htm

http://www.fda.gov/newsevents/testimony/ucm115209.htm

bradfor123 said...

thefamilyman we are in phase one april 2014 now how it is possible to have fda approved by next year are you kidding me please I am not trying to be rude but what evidence do you have of this.

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