Let's not forget, a decision could happen any time now. Nearly all FDA applications are answered WITHIN 60 days.
At the most we are looking at 7 weeks, but it could even be next week for all we know.
My own view is that we will get approval.
I know some of us have mentioned this before but......(from FDA guidance compliance)
A drug that is intended to treat a serious condition AND preliminary clinical evidence indicates that the drug
may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies.
http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm358301.pdf
The NNZ-2566 from what we have been informed publicly, and as far as we know, meets this criteria. This is because there has been improvement in core outcomes and there IS NO other treatment.
The pullback on the SP today in my view is the best and last opportunity to get in or top up before the hype leading up to the ann. which could be at anytime.
Good luck
FDA decision within 1-50 days
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