GREY:TSTIF - Post by User
Comment by
ElanS2on Jun 17, 2016 2:58pm
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Post# 24975427
RE:RE:RE:CLOCK
RE:RE:RE:CLOCKThe FDA refers to the 90 days as being calendar days, not business days, and they are a "goal" and not an absolute. They have a very elaborate way of following up on their annual performance.
This year, 2016, their target is 95% compliance with the 90 day goal. TOS seems to be an outlier with respect to achievement of their goals. In short anything is possible.
At this time I feel the same way I did in 2014 and the OK to commercialize came 6 months latter. The only thing we can be absolutely sure of is that it will come. The form may be a surprise, as it was in 2014 with the new category. As usual we will have to be patient.
When was the request for "Aditional Information" made? I suspect in Jan or Feb, but I have no confirmation of that, nor do you. The "Additional Information" was forwarded June 1st so the clock was on hold for at least three months after it had run for maybe 2 months.