@dplane you are spot on and if I read between the lines what the Dr was saying when Tanushree asked him about his take on another trial and his response being we want it to be approved and if any trial or study needs to be done it's on adults etc .
What I think he is trying to tell FDA is you have an unmet need and you are more at loss of this doesn't get approved . we have couple of further roll outs thy are being worked according to your guidelines .
It's just putting the onus back to FDA but with a diplomatic twist .
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