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Re: Jonjones325 post# 454829

Saturday, 03/23/2024 5:35:35 PM

Saturday, March 23, 2024 5:35:35 PM

Post# of 458469
I'm certainly no expert, but if you go for Complete MA, isn't it still very possible that the regulators will approve with conditions anyway. The only way I would think you'd go for Conditional is if going in the only way you think you can gain approval is by offering conditions you'll meet on the regulator granting such approval. I.E. if you know you have to run additional trials, concede it up front.

In the case of many products, new trials will be needed post approval for label expansion. I see no reason not to say that if it's already acknowledged to be the case.

Gary
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