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Monday, 09/09/2019 4:18:45 PM

Monday, September 09, 2019 4:18:45 PM

Post# of 426184
We are 19 days away from the original PDUFA and still no official word from the FDA.

If Thero did not make that (tentative) ADCOM announcement on August 8, everyone would have expected the FDA approval any day now (tomorrow or next Tuesday would have been my top 2 choices). Imagine the outrage, if instead of the approval, we would have gotten ADCOM + 3 month delay. Would have been a much harder pill to swallow now than it was on August 8.

If Thero would not have made that August 8 announcement, we don't know if the FDA would have acted quicker with regard to publishing it on their registry. But it is a scary thought that they could have let it go unannounced for all this time.
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