“ The primary risk is, as it has always been, the size of the P2b/P3 trial and the lack of a confirmatory trial.”
I agree that could be the issue with the approval. What doesn’t make sense is that those issues were known before the trial application. The EMA’s trial system is designed to vet issues even before application approval, then two clock stops during the process. That’s where the 90 percent approval rate that we keep hearing about comes from. How did we get to the 210 day mark if they were going to reject it due the trial size and lack of confirmatory trial?
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