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| Alias Born | 12/13/2009 |
Monday, August 04, 2025 3:19:25 PM
Well with evidence of the EMA clock ticking again, I will move closer to your assessment of approval chances.
What would be the logic behind that? The blinded clinical trial data has not changed since the CHMP accepted the MAA six months back. The CHMP regulatory process has not changed. Why would just a clock start justify moving your percentage approval chance from 25% to 75%. After all, we don't even know that AVXL has submitted their responses to the LoQ. Even if they have, then the CHMP has just started their review of the responses. The CHMP may conclude that the responses are totally inadequate or simply suck. So where is your logic behind this potential miraculous change in your odds for regulatory approval in Europe based on a stop clock resumption? One might suggest that the only thing that has changed is your personal bias.. Inquiring minds want to know.
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