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Re: biotech_researcher post# 56742

Wednesday, 11/26/2014 2:41:24 PM

Wednesday, November 26, 2014 2:41:24 PM

Post# of 80490

Zusie's post: "We're referring to "Accelerated Approval", which does not require completing clinical trials. Below is the text on Accelerated Approval:"
You are missing the point, imho. It's not about completing the clinical trial as you indicated, it is about completion of patient enrollment that have entered the trial. BIG difference.
Don't you think that Ariad will have to complete the enrollment of the trial before approval? You and TC are in the same camp.



FDA's decision on Accelerated Approval for AP26113 will be based on the results from the past clinical and the on-going clinical data, and most importantly the voice/the need from doctors and cancer patients community. There is no difference whether completing the enrollment or the clinical trial itself.

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