It recycles on the OB page at the FDA website. The company is not notified in advance...just magically appears with only the FDA being able to trade inside information;). They usually like to trade options, like the thousands of Feb calls bought today at 9 & 9.5.
I think the smart #$%$ shorts bought those as protection but looks like FDA and Joe tricked the shorts with a OB update delay. Now if the OB gets updated with a yes NCE on Tuesday then shorts have no protection. perfect timing