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rafunrafun

09/01/16 7:48 AM

#90795 RE: HDGabor #90792

Pardon my ignorance but if they resubmit, wouldn't they be using RI trial data to apply for ANCHOR approval?
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me33

09/01/16 7:50 AM

#90796 RE: HDGabor #90792

G-
But the company will be able to resubmit only if RI data becomes available which requires interim stop.
If a recommendation is to continue, resubmission is not an option as the company will continue to be blinded to the data. Moreover, futility won't be ruled out either as interim won't analyze for futility.
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sts66

09/02/16 6:31 PM

#91014 RE: HDGabor #90792

Appears you are saying AMRN responds to ANCHOR CRL with R-IT data, but R-IT supersedes ANCHOR, it's a much broader indication with a different label - surely that requires a new and separate sNDA, not a modification/retrofit of ANCHOR sNDA? That's what nearly everyone here has been claiming and believing for a long time (except BB), including yourself IIRC - that is ANCHOR dead, end of story.