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Re: Joseph_K post# 453620

Thursday, 03/07/2024 12:51:09 PM

Thursday, March 07, 2024 12:51:09 PM

Post# of 458906
Joseph, as to your question regarding submission announcements by the company and/or the EMA, I can recall on at least one occasion Missling saying that the company would announce the filing of a formal drug application. (I don't know if he meant after acceptance or prior or both.) As to the EMA, my correspondence earlier in the year with a Greek woman in the Regulatory Affairs department yielded the following response: "There is usually an announcement at the start of the marketing authorization assessment when the dossiers are received which you will find out by following the announcements that EMA is doing periodically." Vague enough for bureaucratic purposes?
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