Clarification for the record:
One sentence in the original post referred to the timeline as “7 months post-submission.” That was an oversight. The MAA was submitted on December 20, 2023. Today is July 28, 2025. We are now 19 months post-submission, not 7. The process described, validation, review, RFIs, labeling, SmPC finalization, and the regulatory handoff, remains exactly correct. This clarification does not affect any of the underlying facts, regulatory citations, or structural logic in the post. It simply updates the numerical timestamp.
Bullish