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Re: baltimorebullet post# 457690

Friday, 04/26/2024 11:48:13 AM

Friday, April 26, 2024 11:48:13 AM

Post# of 458511
Baltimore, I have not heard of any new timeline given by the company on the MAA filing beyond the original "as early as possible in 2024." We do know, however, that when the company formally requested the appointment of rapporteurs on (or as much as 4 weeks before) February 7th, they had informed the EMA that the planned MAA submission date was prior to September 7, 2024. We know this because the company had to have an MAA submission date no more than 7 months later before the EMA would initiate the rapporteur selection process. On March 4 (at TD Cowen) Missling told us that he was awaiting notification of the rapporteurs and said that they were in the rapporteur selection process. The most recent filing deadline for the process at that time was February 7. I suppose since he said that they were awaiting notification, they could have met the January 10 deadline and that 6-7 business days after the selection process was theoretically over, the specific notification had not yet been given. I tend to go with February 7, but either way the target for submission was Q3 at that time.
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