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boi568

12/19/23 1:49 PM

#443216 RE: Joseph_K #443210

After submission, the EMA can choose to reduce its review time from 210 days (working days, on their clock) down to 150 days. I think I have seen a reference to even shorter EMA review periods.

bas2020

12/19/23 3:36 PM

#443240 RE: Joseph_K #443210

"On request, the CHMP can reduce the timeframe to 150 days if the applicant provides sufficient justification for an accelerated assessment. ...


This is what NWBO has requested...