At this point, there are a lot of unanswered questions that just don’t make sense. How we made it through the whole 210 day process just to get rejected at the end. We have been led by believe that the EMA process was very systematic. They prescreen before submitting. Interactive exchange through the process. IF we make through CS1, AI sites say 90% chance of positive opinion. If there was such a show stopping problem from the beginning, how did it ever get this far? Sounds like that was all BS. I don’t even know what to think at this point.
It’s all BS until a new P3 is complete AND succeeds. Gravedigger may be right that the FDA will be first. They are faster and generally more lenient. But if this occurs it will be in 2030
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