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Hosai

07/03/24 5:45 PM

#463317 RE: williamssc #463315

Unfortunately the 67 day thing I believe refers to the procedural element at the end where the EMA (nearly always) approves around 2 months after the CHMP has made their own decision/recommendation.
The whole thing would likely take a year once application is submitted, though could be quicker if with accelerated pathway.