Montana ETRB

An independent board that evaluates experimental treatments through safety-focused review under Montana Senate Bill 535.

[Montana ETRB @MontanaETRB]

https://t.co/qQzZIzUhcC

[Montana ETRB @MontanaETRB]

The Montana Experimental Treatment Review Board (ETRB) held its monthly meeting and reviewed two submissions under SB 535. The Board issued two Review Decision Letters:

• RDL-2026-002: WinSanTor, Inc., WST-057 (topical pirenzepine 4%). Approved with conditions.

• RDL-2026-003: MuseCell Innovations Pte. Ltd., Dezawa MuseCells (allogeneic cell therapy). Deferred pending additional information. This is not a disapproval.

All Review Decision Letters issued by the Board are now available in a public repository ↓

[Montana ETRB @MontanaETRB]

https://t.co/WP434n59kH

[Montana ETRB @MontanaETRB]

Every treatment the Montana Experimental Treatment Review Board approves must generate evidence on its safety and outcomes.

The Board’s Guidance on Continuing Evidence Generation requires each submission to include a framework for collecting, reviewing, and reporting safety and outcome data while the treatment is offered.

The requirement scales with existing oversight. Treatments under an active FDA IND or IDE, or an equivalent WHO Listed Authority approval, generally meet it through existing reporting. Others require IRB-reviewed research or an ETRB-approved monitoring framework.

The Board will not approve products under an FDA clinical hold, withdrawn for safety reasons, or shown in well-controlled trials to lack meaningful benefit or cause net harm.

[Montana ETRB @MontanaETRB]

https://t.co/jKAbGmsvOi

[Montana ETRB @MontanaETRB]

During our September meeting, we addressed questions from prospective applicants on Phase 1 requirements, safety study design, and supporting evidence.

Our first Guidance Letter sets out how these issues will be considered in ETRB review:

[Montana ETRB @MontanaETRB]

Montana Experimental Treatment Review Board has completed the review of its first treatment protocol submission.

On August 26th the ETRB unanimously voted to approve, with conditions, Parley Neurotech's combination therapy (LOOT) for use at Experimental Treatment Centers in Montana.

This is the first treatment protocol approved for use under the Montana SB535 Right to Try pathway.

Our Review Decision Letter (RDL) will be published at https://t.co/Yrr9WLgr8R shortly.