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Not going to flame you for not knowing what you are talking about, but will explain.FDA accepted the filing for the new indication. It has not been approved for the new indication. PDUFA date is the anticipated date that the FDA lets the company know if they are going to approve or not.Few scenarios could play out in April. Nuplazid get approved for new indication. FDA does NOT approve for new indication. FDA comes back and says that want more data from existing studies or more studies done because of XYZ. This is not a slam dunk that it gets approved. IF it does not get approved for dementia, my understanding is that reps got paid to go thorugh training and with no new indication will be cut loose.
Not going to flame you for not knowing what you are talking about, but will explain.
FDA accepted the filing for the new indication. It has not been approved for the new indication. PDUFA date is the anticipated date that the FDA lets the company know if they are going to approve or not.
Few scenarios could play out in April. Nuplazid get approved for new indication. FDA does NOT approve for new indication. FDA comes back and says that want more data from existing studies or more studies done because of XYZ. This is not a slam dunk that it gets approved. IF it does not get approved for dementia, my understanding is that reps got paid to go thorugh training and with no new indication will be cut loose.
