Montana Experimental Treatment Review Board Announces First Review Decision Under SB 535
MONTANA, August 31, 2026
The Montana Experimental Treatment Review Board (ETRB) announces the completion of its first application review and the issuance of its first Review Decision Letter (RDL) under Montana SB 535 (69th Legislature, Chapter 621) and ARM 37.106.3301 through 37.106.3325.
On August 26, 2026,the Board voted unanimously to approve, with conditions, Review Decision Letter RDL-2026-001 concerning Parley Combination Therapy (LOOT), a treatment that is under active investigation in clinical trial NCT07304024, submitted by Parley Neurotech, Inc. of Denver, Colorado, for use in medical practice in Montana.
This is the first treatment protocol approved under the SB 535 pathway.
The approval is subject to binding conditions. It becomes effective for medical use at Montana-based experimental treatment centers (ETC) that designate the Board as their required ETRB upon written confirmation by the Chair that the conditions have been satisfied.
The full Review Decision Letter, RDL-2026-001, sets forth the Board's determinations, the conations of approval, and continuing obligations.
MONTANA, August 31, 2026
The Montana Experimental Treatment Review Board (ETRB) announces the completion of its first application review and the issuance of its first Review Decision Letter (RDL) under Montana SB 535 (69th Legislature, Chapter 621) and ARM 37.106.3301 through 37.106.3325.
On August 26, 2026,the Board voted unanimously to approve, with conditions, Review Decision Letter RDL-2026-001 concerning Parley Combination Therapy (LOOT), a treatment that is under active investigation in clinical trial NCT07304024, submitted by Parley Neurotech, Inc. of Denver, Colorado, for use in medical practice in Montana.
This is the first treatment protocol approved under the SB 535 pathway.
The approval is subject to binding conditions. It becomes effective for medical use at Montana-based experimental treatment centers (ETC) that designate the Board as their required ETRB upon written confirmation by the Chair that the conditions have been satisfied.
The full Review Decision Letter, RDL-2026-001, sets forth the Board's determinations, the conations of approval, and continuing obligations.
This approval reflects the Board’s professional judgment on the record submitted. It is not approval or clearance by the U.S. Food and Drug Administration, is not a determination of efficacy or therapeutic benefit, is not medical advice or a recommendation to any patient, and is not a warranty that the treatment is safe. Responsibility for development, manufacture, supply, and clinical delivery rests with the applicant, the experimental treatment center, and treating providers.