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Re: All-Bidness post# 83090

Monday, 06/08/2020 6:22:14 AM

Monday, June 08, 2020 6:22:14 AM

Post# of 232162
So finally FDA acknowledged the BLA letter - so what was the advantage of the rolling review?

Company got rolling review in Mar 2019 and company took more than 1+ year to really submit all parts and still might not get priority review so the approval will come in 2021. So all the big noise about rolling review was for nothing.

This shows that before blaming FDA for delays, one should look at company’s delays
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