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Friday, 02/17/2017 8:36:31 AM

Friday, February 17, 2017 8:36:31 AM

Post# of 459493
Efficacy. A very good reason why AVXL needs to demonstrate efficacy:

"...some of the names Trump is reportedly considering for the critical FDA commissioner job. One potential candidate, Peter Thiel associate Jim O'Neill, has advocated a system where drugs can be approved the minute they're shown to be safe, rather than the dual safety and effectiveness standards which the agency must now consider.

But that radical approach has already shown poor results in the marketplace. Sarepta Therapeutics (SRPT, +0.22%), which won a controversial but pioneering approval to treat the rare disease Duchenne muscular dystrophy, has been shunned by a number of insurance companies because (as the FDA admitted in its own approval) the treatment doesn't have proven efficacy."

http://fortune.com/2017/02/15/trump-fda-deregulation-biopharma/



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