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Re: Biobillionair post# 180511

Tuesday, 03/12/2019 6:00:02 PM

Tuesday, March 12, 2019 6:00:02 PM

Post# of 425652
EU accelerated assesment actually gets requested months in advance of submission, whereas w/ sNDA and FDA it goes in parallel w/ the filing.

So depending on submission timing, we might know of a decision on accelerated review in EU, ahead of US. They might even know the decision already. I inquired to IR about this topic (e.g. have they already requested AA in EU, are they engaged in presubmission meetings w/EMA, etc), and they weren’t able to share any details.
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