Approval of the original NDA and any changes to it is always silence except in the beginning only, sometimes companies go for a Special Protocol Assessment, which again, can only occur before a trial starts and is still not a guarantee.
So no, they never give anything in writing generally, so that they always have all their legal options open to change their mind. But they can’t do that arbitrarily, under very strict administrative law rulings. So generally it’s only if they had a strong reason for instance to think there was some safety issue or some reason that their decision previously was flatly wrong, like if they changed their reasoning on a subject. In this case, the modifications are consistent with there the law and agency are moving from a policy perspective and it is highly likely the company was pointed in this direction by the agency, at least IMHO.
Agencies want positive outcomes that advance the field. I have no real worries, but it’s all IMHO.
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