According to the link above 'Currently, about 40% of de novo submissions are reviewed in 150 days'. Apparently there is a FDA objective to increase this percentage in coming years.
I seem to recall TK's recent interview with Morgan's that he thought approval would likely be in the early period of 3-6 months after submission of the application. That sounds about right to me, especially if they can demonstrate they've ticked every box and followed every piece of advice from their presubmission meeting with FDA in March last year.
RAP Price at posting:
30.5¢ Sentiment: Buy Disclosure: Held
