|Clinical and Regulatory|
|Event Type:||Phase 3 Results|
|Designation(s):||Orphan Drug, Priority Review|
This event is set for a specific date and makes planning easier. However, specific dates may change.
|Disease and Treatment|
|Indication:||Neuroendocrine tumor diagnosis|
|Treatment Name:||Lutathera (177-Lu-Dotatate)|
Likelihood of event success varies depending on disease, treatment and lead indication classification.
|Co. Name:||Advanced Accelerator Applications|
The OTC BB and OTC Markets have less stringent reporting and financial requirements than the NASDAQ and NYSE. This may increase the level of risk for investors. Smaller size may have an influence on likelihood of success.
Partnerships help smaller biotech companies finance the long approval process. Partnership also provides validation the clinical program may be a worthy investment.
Detailed Event Description from Company Announcement
25 February 2016, Saint-Genis-Pouilly, France – Advanced Accelerator Applications S.A. (NASDAQ:AAAP) (“AAA” or “the Company”), an international specialist in molecular nuclear medicine, today announced both updated data from the pivotal Phase 3 NETTER-1 study investigating the treatment of Lutathera (177-Lu-Dotatate) in patients with inoperable, progressive, somatostatin receptor positive midgut neuroendocrine tumors (midgut NETs) as well as Prescription Drug User Fee Act (PDUFA) date update for Somakit-TATE New Drug Application (NDA).