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Re: frrol post# 457724

Friday, 04/26/2024 5:22:49 PM

Friday, April 26, 2024 5:22:49 PM

Post# of 458483
My understanding is that the second gating factor is when the company files for the rapporteurs. It won't get worked on until 7 months before the targeted MAA date. The EMA also advises against filing for the rapporteurs much later than 7 months prior. If the company also filed that in early/mid-December, then it would have met the January 10th submission deadline for the rapporteur process. It means that when Missling said on March 4th that he hadn't been notified yet on the rapporteur(s), the EMA had waited more than 6 or 7 business days after the published selection days to advise him of the outcome. Certainly possible, but it could also be that the company filed prior to the February 7th deadline (and they would have then been in the process, as Missling said, but were not going to be notified until after March 21st.) So, it seems to me, depending on our interpretation of Missling's comment, that the 7 month minimum until filing for the MAA would mean early/mid July to early September (at the very latest) for the MAA target given to the EMA, assuming the company does prepare it expeditiously, as you say. While mid-June is not inconceivable, I suppose, it seems quite unlikely with only three months left to work with the rapporteurs. I just prefer to expect Q3, leaning toward the first two months.
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