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WilliamMunny

01/10/24 11:25 AM

#447059 RE: Anshu2 #447002

Funny how the EMA didn't pick up on that...

Joseph_K

01/10/24 11:40 AM

#447064 RE: Anshu2 #447002

You and I don't have the dosage arm data, but the EMA would. Missling, IIRC, has indicated that the 30mg and 50mg did not vary much. I don't have the expertise to know, but it strikes me as possible that it would be easy to approve the 30mg under those circumstances, assuming all else being acceptable. Considering the safety profile, depending on the actual data, it's less likely, but doesn't seem all that farfetched, even to approve at a higher dosage.