PDUFA Priority Review (SPRO)

It was previously reported on May 3 that the Data Package may not be sufficient. Subjectively, that could result in an early dismissal from the FDA, a voluntary delay from the company, or the FDA could ask for an Advisory Committee Meeting.

With the questions about the data looming, the runup period might not be as fruitful as others. Also, the potential for any number of decisions that would likely come early, could scare away the Runup and the Event Day crowd.