Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

After hearing him discuss Rolontis, I feel reassured the timeline of submitting a BLA in the 4th Q is all systems go

Per their PR today

Spectrum Pharmaceuticals Announces ROLONTIS™ (eflapegrastim) Met the Primary Endpoint in the Phase 3 ADVANCE Study Feb 5, 2018
• The ADVANCE study met the primary efficacy endpoint of non-inferiority in Duration of Severe Neutropenia between ROLONTIS and pegfilgrastim; adverse event profile was similar between the two treatment arms.
• RECOVER, the second Phase 3 study, is now fully enrolled. The Company plans to file a Biologics License Application (BLA) in the fourth quarter of this year.
• ROLONTIS is a novel, long-acting granulocyte colony-stimulating factor (G-CSF) that utilizes a proprietary technology.

http://investor.sppirx.com/news-releases/news-release-details/spectrum-pharmaceuticals-announces-rolontistm-eflapegrastim-met

The body of the PR also confirms their is no difference in safety with Neulasta.