|Clinical and Regulatory|
This event is set for a broad date range and therefore the exact timing is unknown. This adds a degree of risk.
|Disease and Treatment|
|Indication:||HER2-positive Breast Cancer|
|Treatment Name:||Neratinib + Trastuzumab|
Likelihood of event success varies depending on disease, treatment and lead indication classification.
|Co. Name:||Puma Biotechnology|
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
The FDA accepts for review Puma Biotechnology's (NYSE:PBYI) New Drug Application (NDA) seeking approval of neratinib (PB272) for the extended adjuvant treatment of patients with early-stage HER2+ breast cancer who have been previously treated with adjuvant trastuzumab-based therapy (Roche'sHerceptin)... The specific FDA action date (PDUFA) is not provided, but should be in July 2017