Since it has a SPA protocol,it will be 180days (instead of 360 days) after the company files the NDA. The NDA will soon be filed after the study results. (New Drug Application).
You asked about when FDA approval is expected not P3 which is what appears to pertain to this F-R rule which means absolutely nothing (except as an indicator of probability)
According to the company they expect to hear FDA results (positive or negative) for Zoptrex in April. According to Dodd per last weeks meetings in NY they are in negotiations with at least one or more potential customers in for rights to Zoptrex (but feel its in the companies best interest to wait (for positive results to get a better deal) for the FDA.
Also, their other product they are hoping for an FDA reversal on Macrilen they will likely have an answer from the FDA in March. It missed by a very small amount on the original attempt and I personally believ will get passed this time.
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