Regulatory SupportChanges to the regulatory landscape seem to support a more favorable environment for NurOwn, with the agency more open to evaluating large datasets and understanding how biomarkers correlate with patient outcomes.
Study Success PotentialCombined with the special protocol assessment (SPA) agreement for NurOwn's P3b and alignment on manufacturing, there is an increasing probability of success for NurOwn provided the P3b data is positive.
Therapy ValidationThere is increasing traction for MSCs within ALS with 5 groups now targeting ALS, providing additional validation for NurOwn – BrainStorm's proprietary cell therapy platform.