It certainly is taking quite a while. The drag on share price is very evident. It's unfortunate that we are almost a year from the PDUFA date and still have no idea when/if it'll get approved. Since the FDA didn't do any sight visits for such a long time, I would have thought they would have used the extra time to have the rest of their report all done and just wai for inspection part of their report to be written after their inspection in June. Seems like it should have just been a formality since RVNC had forever and a day to get their ducks in a row to prepare for inspection. I am certainly nervous the inspection didn't go as planned.
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