The presubmission meeting itself is meaningless but I like to see the wheels turning and that they didn't blow past another deadline. Given so many have complained about the lack of communication it's a positive update. It looks like this FDA submission will be managed more closely in-house rather than through consultants, who are generally a rip off.
Ann: Pre-Submission package lodged with the US FDA, page-10
Currently unlisted. Proposed listing date: 4 SEPTEMBER 2024 #
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