Im assuming that the upshot at a bare minimum is that, assuming we are confident we can resolve the outstanding concerns that the FDA had (big assumption) we still need to submit the application again ab initio, ie from the beginning of the queue and that it will take the same 6-9 months to get through the process? Or is there a sped-up path we can take given we have satisfied most of the issues already? Would appreciate if someone could confirm with TK as I wont be able to
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