Sunday, March 18, 2018 12:43:43 PM
So, timing of the approval is kinda like this...January 17 is when the face to face with the FDA occurred. It was at that time, or thereabouts, that they completed their submission. That’s when the clock starts. If the FDA has no further questions or document needs then we should see an approval between April 17 and July 17.(that’s according to what they said in the primer)
It’s certainly not an absolute and being in the Ctq Pilot Program might actually speed up the process. So, my guess would be we could see an approval between now and May as the best case scenario. I also think that the EU approval bolsters their case for a quick approval, IMO.
DR5
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