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Investor082

07/28/25 7:45 PM

#778511 RE: Slave1 #778509

The AI has been trained to BS as well, LOL!

The AI thinks we are still in 2024. The timing is on track - 7 months post MAA submission, LOL! ;)
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Slave1

07/28/25 8:06 PM

#778512 RE: Slave1 #778509

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
Bullish
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JTORENCE

07/28/25 9:02 PM

#778529 RE: Slave1 #778509

Slave1 "seven months???


Timing Is Still On Track

The application was submitted on December 20, 2023. Assuming a typical validation and review start in January, the process has now run just over seven months. This is in line with historical timelines for Advanced Therapy Medicinal Products. Even if we assume minor delays for RFIs, we are still inside the expected window.