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Re: SJSTOCKSHARK post# 3194

Sunday, 10/22/2017 1:34:19 PM

Sunday, October 22, 2017 1:34:19 PM

Post# of 6378
SJ, it's hard to estimate how long the company will take, however seeing as how there are not a ton of data points being measured, it should be pretty quick. I hope with the slow rate of enrollment they are preparing data in real time and adding new data as it comes in. If that's the case I hope they can submit within 1-2 months of completing the trial.

Regarding review time by the FDA, accelerated approval is the one area in the expedited approval program where the FDA refuses to commit to a review timeline. All the other programs commit to a response within 60 days. I've never been involved with an accelerated approval so I can't speak from experience.
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