Thursday, April 20, 2023 10:11:09 PM
So, the next question: Do the regulatory updates announced in October 2022 by MHRA require the level of revisions to the CMC that would explain the submission of the MAA taking until June of 2023?
Seems to me the difference between domestic and global distribution is much more about logistics than supply chain, with both requirements being addressed in connection with the MIA. So why the lag between the issuance of the license and completion of the CMC?
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