Supports scientific research utilizing data from expanded access programs for investigational drugs or biological products targeting intermediate size ALS patient populations not eligible for ongoing clinical trials. Research focuses on prevention, diagnosis, mitigation, treatment, or cure of ALS, requiring participation in pivotal phase 2/3 or phase 3 clinical trials sponsored by FDA-designated small business concerns.
Eligible applicants include clinical trial sites participating in phase 2/3 or phase 3 efficacy clinical trials supported by FDA-designated small business sponsors of investigational drugs or biological products for ALS. Foreign organizations and foreign components are not eligible.
