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Hosai

06/12/24 4:16 PM

#460997 RE: WilliamMunny #460993

Hi William, I did see this. I think there are diffent ways to view this sentence its a bit confusing - "We advise applicants to notify the EMA of their intent to submit and request assignment of (co-) rapporteurs seven months prior to the intended submission date. Although applicants may submit the letter of intent earlier than seven months prior to the intended submission date, the (co-)rapporteurs appointment procedure will not be initiated prior to that date."

I think it's the case that the request for rappateurs has to be done 7 months before (which potentially is done at same time as intent to submit?) rather than to have to actually have rappateurs appointed 7 months before.
Also I think the last part of the sentence is basically saying you could give intent to submit earlier than 7 months before planned submission so for example a year or 18 months before but they start the appointing rappateurs procedure until planned submission date would be due within a maximum of 7 months.

Therefore in terms of the minimum I don't think there would be a minimum after rappateur selection (at-least under this interpretation). Google gemini seems to think this too though it can't always be depended on.
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Steady_T

06/12/24 4:53 PM

#461004 RE: WilliamMunny #460993

Being in the rapporteur application process to me means that the 7 month waiting period has started. The fact that Missling said on March 4th that they were in that process doesn't indicate when that 7 month process started.

I hope your interpretation of the available information is correct. That is not the way I interpret it.

I am confused by your last sentence in light of what you said earlier in your post.

Looks to me like mid/late August or the first week of September. Hope all this was reasonably clear and helpful.



Is this the time frame you are expecting the MAA to be filed?
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Investor2014

06/12/24 5:48 PM

#461022 RE: WilliamMunny #460993

Which means it will be about a year before we might have a positive MAA outcome or sooner if not.