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Re: HDGabor post# 34685

Thursday, 09/18/2014 7:13:33 AM

Thursday, September 18, 2014 7:13:33 AM

Post# of 425931
HD, my congratulations: unfortunately this second effort has merit IMHO.
The Theravance case and the quoted sentence about the rescinding power given to the director of the review, and your following reasoning, taken together constitute a stronger founding reason for the rescission.
Maybe also the new question put to the AdCom advisors that can be reasonably summarized with the Hiatt's statement “the issue on the table today is whether we should approve something as a surrogate endpoint” turns to be legitimate ...

So, what should we expect now? Not hope, but expect on this basis?
Thanks HD
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