however , in the th notice they reference the fact that there HAS been some form of FDA comms already....
its not just a random precautionary th by BOT being proactive....
the big unknown is what was communicated and that is the basis for all and any speculation
it could be that SB gel was put before the voting members friday arvo but formal notification wont be avail until monday US.... thats plausible and the optimistic view especially since no approvals at all appear on the fda list for 22nd sept.
otherwise , its what we have all seen before , communication of not able to approve at this time and the th allows bot the 2 days to explain the new path forward to get it approved, however it may look and take
both outcomes are possible and speculation is natural as the time passes by....
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