GREY:TSTIF - Post by User
Comment by
ElanS2on Jun 15, 2016 2:29pm
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Post# 24968228
RE:RE:RE:RE:RE:RE:Report coming
RE:RE:RE:RE:RE:RE:Report comingAs I understand the process, which may not be the case, this most recent submittal was a response to a reqest for additional information by the FDA concerning a demand for approval previously submitted for the extended claims. When the original submittal to approve the extended claims was made I do not know. Why is that important ? If I am right the 90 day clock has already been running. The FDA clock starts when they accept the documents requesting approval and runs until the clock runs out, the request is rejected, or they submit a demand for additional information at which point it pauses allowing time for the requestor to prepare his response, and only starts running again when the additional information is received by them.
If I am right the remaining time on the clock could be much less than 90 days.
If anyone is aware of the date that the request to approve the extended claims was submitted initially please speak up. If I am wrong about the existence of such a request please correct me.