Remember again that this feedback was only given on Friday. These requirements are not specific to all drugs, because all drugs are not the same, this is the feedback that the FDA as the regulator has decided that is needed for this drug (the first of its type to be approved otherwise we wouldnt be here getting approval in the first place). Remember that it was not raised by the FDA in prior meetings as something that was needed. all the specifics are determined by the FDA when they are looking at all evidence around what is needed.
Its not like anyone can look up what the FDA experts are going to decide what is needed for the speciifc drug.
The updated timeline was in the meeting. (it's mainly on the regulator side that we sit and wait again).
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