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Re: Steady_T post# 461004

Wednesday, 06/12/2024 6:27:07 PM

Wednesday, June 12, 2024 6:27:07 PM

Post# of 517228
Steady, on March 4th Missling said they were in the rapporteur selection process and were waiting for notification. Excluding the possibility that that they filed prior to the January 10th submission deadline and the EMA was over a week late in notifying them, we can presume they filed the request in time for the February 7th submission (i.e., on any date between January 11th and February 7th), which officially started the rapporteur process. Therefore by February 7th the projected MAA filing was seven months or a few weeks less away, as I see it. How do you interpret it?

As to the last sentence, I am using those dates based on the above theory that the seven month prior mark was between mid-January and February 7th. I am only saying that is what he told the EMA. In recent weeks he seems to have said publicly that the process is moving quite well. He has to make a filing 2-3 months before the previously projected MAA submission date to either confirm it or amend it, as I recall. If I am right about the earlier projection of mid August to early September, that would be in the coming three to four weeks. Hopefully an amendment, if any, will be fairly minimal.
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