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oldberkeley

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oldberkeley

Re: DewDiligence post# 197474

Friday, 11/20/2015 12:12:46 PM

Friday, November 20, 2015 12:12:46 PM

Post# of 251777
Re BMRN briefing docs:

Importantly, the evidentiary standards for effectiveness are not lower for biomarker endpoints used to support Accelerated Approval, nor should Accelerated Approval be used to compensate for weak or inconsistent clinical findings.[Bolding mine]

Doesn't this speak precisely to the point that DMD parents and advocates—and supporters of other orphan drugs—have been making for years: that any benefits trump any risks?

Do you think that this passage is included in the memorandum as a reminder and a message to all drug companies?

All that is needed to make a happy life is within yourself, in your way of thinking. -Marcus Aurelius

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