Per the statement from TLON, "We will continue to work collaboratively with the FDA during this review process and will continue on-going label negotiations," stated Steven R. Deitcher MD, President, Chief Executive Officer and Board Member of Talon Therapeutics. "In addition, we will continue to conduct our Phase 3 confirmatory trial, which received Special Protocol Assessment agreement from the FDA, in front-line adult elderly ALL," Dr. Deitcher added.
Sounds like it may only be a labeling issue? Is it possible to receive a decision prior to the end of the 90 day extension?
Still holding and may add if the price is right.
GLTA