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OldYeller187

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OldYeller187

Re: Biobillionair post# 186052

Sunday, 04/07/2019 9:08:45 PM

Sunday, April 07, 2019 9:08:45 PM

Post# of 424759
BB, the request for EU Accelerated Assesment goes in 2-3 months before submission, sometimes earlier. CHMP decision comes about 1.5 months after request for AA.

There are also presubmission meetings w/ EMA 7 or 8 months ahead of submission where AA is discussed as well as the actual submission. These are not required, but are strongly recommended to applicants.

I inquired to IR about the request for AA, and also presubmission meetings, but they couldn’t give me any info there, unfortunately. Was hoping to learn about some of their interactions w/ EMA.
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