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Re: None

Friday, 08/05/2016 8:24:17 AM

Friday, August 05, 2016 8:24:17 AM

Post# of 252311
DMD / PTC / SRPT:

I didn't listen to the call but skimmed the transcript. I thought this interesting (can't disagree with them) criticizing FDA for not treating applicants fairly (I think FDA already opened themselves up to this and other criticisms in how they've handled DMD drugs)


Point two, we believe that the Refuse of File letter we received from the FDA was not consistent with their actions with respect to other companies who submitted the NDAs for the treatment of the Duchenne muscular dystrophy. The FDA accepted those files for full review, indeed the FDA has previously approved drugs that did not meet their primary endpoints. Applicant in front of regulatory agencies have a right to expect equal treatment.



http://seekingalpha.com/article/3996148-ptc-therapeutics-ptct-ceo-stuart-peltz-q2-2016-results-earnings-call-transcript?part=single

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