| Clinical and Regulatory | |
|---|---|
| Event Type: | PDUFA |
| Timing: | 05/09/2016 |
| Designation(s): | Orphan Drug |
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This event is set for a specific date and makes planning easier. However, specific dates may change.
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| Disease and Treatment | |
|---|---|
| Disease: | Oncology |
| Indication: | Conditioning treatment prior to hematopoietic stem cell transplantation in patients with multiple myeloma |
| Lead Indication?: | No |
| Treatment Name: | EVOMELA™ (melphalan) |
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Likelihood of event success varies depending on disease, treatment and lead indication classification.
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| Company Information | |
|---|---|
| Co. Name: | Spectrum Pharmaceuticals |
| Stock Symbol: | SPPI |
| Shares Traded: | NASDAQ |
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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.
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| Event Status | |
|---|---|
| Event Outcome: | Positive |
| Event Discussion: | Forums |
| Event Announcement(s): | http://www.sec.gov/Archives/edgar/data/831547/000083154716000053/exhibit991q42015.htm |
| Partnership: | Yes |
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Partnerships help smaller biotech companies finance the long approval process. Partnership also provides validation the clinical program may be a worthy investment.
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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.