Aastrom intends to initiate Phase 3 clinical testing of its treatment for CLI in early 2011.
Aastrom said that the designation may allow it to submit portions of the Therapeutic Biologic Application on a rolling submission basis.
Aastrom president and CEO Tim Mayleben said that fast track designation is an important step for their CLI program and underscores the importance of finding an effective treatment option for this devastating disease.
"It may also accelerate the timing of our regulatory submissions to the FDA and expedite FDA review of our marketing application once Phase 3 testing is completed. We greatly appreciate the FDA’s support of this important clinical program," Mayleben said.