In the BioSpace article that was published last Wed, 3/15, Arman said "the regulator then came back in February with a sixth item,
for which the company has since submitted documentation." Given that it takes more than a couple of hours to write the article and get approval for it, I have to assume the interview was conducted prior to last week. Additionally, for the FDA to have responded in February leads me to belive they submitted the first 5 responses some time in January. The point that I'm trying to make is the FDA has probably been reviewing their responses to the first 5 questions for almost 2 months now, and I assume they'll make a decision shortly after receiving the response to the 6th question which, again, I assume they got well over a week ago. As ER said, Cyrus can get the final response any day now
Quote:
The indication was this was a simple question. I assume questions 1-5 were answered adequately.