re: Ann: Complete Response Letter from FDA Re... "Didn't tell us anything we didn't already know!!"
Are you kidding? It told us that the FDA is not going to impose any additional requirements over and above the current regime of the study and patient enrollment.
That was the big concern prior to the meeting.
Since the meeting took place over the weekend and the senior management would not have had much time to strategize, (I guess they were in the US for the meeting) I would not have expected anything more from the announcement at this stage.
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- Ann: Complete Response Letter from FDA Received
Ann: Complete Response Letter from FDA Received , page-6
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