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Posted On: 02/16/2021 7:05:13 PM
Post# of 148951
Typically they will need a few weeks to review the data. If its the case that we are doing all of the analysis before we request EUA, that would be my expectation.
However, if we in fact sent the data to the FDA immediately upon unblinding, that could shorten the timeframe for us.
It's hard to say which direction we've gone, as we have not had any sort of update.
I would think that the FDA would be pushing to get an EUA as soon as humanly possible, but I also thought that they would help therapeutics complete their trials in under a year. So, who knows.
However, if we in fact sent the data to the FDA immediately upon unblinding, that could shorten the timeframe for us.
It's hard to say which direction we've gone, as we have not had any sort of update.
I would think that the FDA would be pushing to get an EUA as soon as humanly possible, but I also thought that they would help therapeutics complete their trials in under a year. So, who knows.
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