PainReform Ltd. provided a regulatory update on the second part of its Phase 3 clinical trial of PRF-110 in patients undergoing Bunionectomy surgery. The Company's supplier of the API (active pharmaceutical ingredient) has received a deficiency notice from the FDA related to its Drug Master File (DMF). The DMF is the file on record with FDA representing the manufacturing process and facility for the production of the API.

As a result, the second part of Phase 3 trial is expected to commence once the required information has been provided by the supplier to the FDA and the deficiency notice has been resolved. None of the issues raised relate to the Company's PRF-110 product.