|Clinical and Regulatory|
This event is set for a specific date and makes planning easier. However, specific dates may change.
|Disease and Treatment|
|Indication:||Conditioning treatment prior to hematopoietic stem cell transplantation in patients with multiple myeloma|
|Treatment Name:||EVOMELA™ (melphalan)|
Likelihood of event success varies depending on disease, treatment and lead indication classification.
|Co. Name:||Spectrum Pharmaceuticals|
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
After receiving a Complete Response Letter in October, Spectrum was granted a Type A meeting with the FDA on November 6, 2015. Within days, the company resubmitted the NDA and received a PDUFA date of May 9, 2016. If approved, we plan to launch Evomela with our existing sales force.