As they describe the phase 3 “program” there are two trials within it, evidently running concurrently. I assume they will submit both the safety and efficacy trial data to the fda.
The company’s ASPEN Phase 3 clinical program consists of two trials to evaluate the safety and efficacy of RT002 injectable for the treatment of cervical dystonia in adults: 1) a randomized, double-blind, placebo-controlled, parallel group trial, and 2) an open-label, long-term safety trial. The program is expected to enroll a total of approximately 300 patients at multiple sites in the United States, Canada, and Europe.
