Both FDA and company will announce if there is an approval.
This has been a weird, weird ride. Today was supposed to be the 4th announcement for this company this year. For #1 in May, they botched the news release and kept the hold for too long, after a brief spike after-hours and the excitement (price increase) was gone by the next trading day. For #3 (last month), they get the news 2 days early, halt the stock, but then release it 1/2 hour later and the excitement is gone in 3 minutes. Today, I'm sure everyone thought they would pound that sell button the instant news came out and was waiting all day to do it, but they once again were unpredictable.