For my taste, one good thing about getting in at these levels is a decent run up prior to FDA approval pretty much ensures a profitable trade even if approval gets denied because all we'll only be giving back is some, maybe most, of the paper gains we accrue due to the run up.
1) Phase III data 2) NDA filing by the company 3) NDA acceptance by FDA 4) Announcement of the meeting of the ONCOLOGIC DRUG advisory committee 5) if the data is a BLOWOUT FDA has authority to skip the committee and announce PDUFA date