The Phase 3 study is intended to be a confirmatory study to be completed following the accelerated approval of Marqibo.
Talon president and CEO Steven Deitcher said the SPA represents a written agreement between Talon and the FDA regarding the planned design, conduct, and analysis of Phase 3 ALL trial called Hallmarq.
"HAllmarq will be a global trial with initial clinical site openings expected in the US prior to the end of 2011," Deitcher said.