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Investor2014

06/13/24 11:10 AM

#461071 RE: WilliamMunny #461070

Correct!
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Hosai

06/13/24 11:40 AM

#461073 RE: WilliamMunny #461070

I think this is correct it's just that I think the rules about the time from rappateur request up to submission are about the "maximum time" rather than the "minimum time" in other words the EMA are more worried about appointing rappateurs and the applicant not being ready for their planned submission date rather than the applicant applying slightly earlier than their planned date (aslong as within the 7 months of letter of intent to apply).

Therefore I believe it's correct that theoretically Anavex could submit from 20th June as this would be 7 months after what I think was the letter of intent to apply pr on 20th Nov (which is a minimum amount rule), it's just unlikely they would apply at this point due to what I understand to be the normal expected or imagined amount of time with rappateurs.
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Steady_T

06/13/24 3:16 PM

#461090 RE: WilliamMunny #461070

Do you have link to this rapporteur appointment procedure? I haven't run across that.

I hadn't seen anything that indicated the submitting company had to request the rapporteur appointment.

Maybe we are not talking about the same thing. Are you discussing how the CHMP rapporteur process works internally?

Thanks.