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# Montana’s First Experimental Treatment Clears Private Review
- URL: https://www.theamericanquorum.com/state-news-montana-2026-09-16-b/
- Published: 2026-09-16T15:44:21.000Z
- Updated: 2026-09-16T15:44:21.000Z
- Description: Montana’s first experimental-treatment protocol has cleared a private review board, but patients cannot yet receive it because no center is licensed. The framework permits broader access than federal Right to Try.
- Author: News Desk
- Tags: State News, Montana

Montana’s new experimental-treatment system has cleared its first protocol through a privately operated review board, but patients cannot yet receive the treatment because the state has not licensed an experimental treatment center.

The [Montana Experimental Treatment Review Board approved the protocol in August](https://www.businessinsider.com/montana-right-to-try-prospera-biotech-experimental-treatment-anzinger-2026-9?ref=theamericanquorum.com), according to Business Insider. Developed by Parley Neurotech, it combines 30 days of sound therapy with an antihistamine already approved for other uses, with the aim of treating hearing loss. The protocol has not been cleared by the Food and Drug Administration, and Montana’s Department of Public Health and Human Services did not conduct the review.

That distinction is central to how the state framework works. Montana law defines an [experimental treatment](https://mca.legmt.gov/bills/mca/title%5F0500/chapter%5F0120/part%5F0010/section%5F0020/0500-0120-0010-0020.html?ref=theamericanquorum.com) as an intervention involving an investigational drug, biologic, device or other treatment that is not approved for general use. It generally must have completed a first-phase clinical trial and remain under investigation, or have documented safety evidence from a qualified medical institution under state rules. Those conditions establish an initial safety threshold; they do not establish that a treatment is effective.

The private board, operated by a company owned by the Infinita City development, charges applicants $12,500\. Business Insider reported that its five members include a licensed physician, a clinical-outcomes researcher and an ethicist, as required under state rules. The board said it reviews disclosed conflicts for each application and had identified none in the cases considered so far.

## Access still depends on state licensing

Montana separately requires any experimental treatment center to obtain a state license before operating. Under the [licensing statute](https://mca.legmt.gov/bills/mca/title%5F0500/chapter%5F0050/part%5F0020/section%5F0500/0500-0050-0020-0500.html?ref=theamericanquorum.com), the health department has 90 days to act after receiving a complete application, and its rules cover inspections, operational standards, patient-safety procedures, outcome monitoring and adverse-event reporting. Two center applications were incomplete as of Business Insider’s September 15 report, leaving the newly approved protocol without a lawful treatment site.

Patients who eventually seek care must provide [written informed consent](https://mca.legmt.gov/bills/mca/title%5F0500/chapter%5F0120/part%5F0010/section%5F0050/0500-0120-0010-0050.html?ref=theamericanquorum.com). The disclosure must describe approved alternatives, the best, worst and most likely outcomes of the experimental option, and the possibility that health insurance will not cover the treatment or resulting care.

Montana’s approach reaches beyond the federal [Right to Try pathway](https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/right-try?ref=theamericanquorum.com), which is limited to patients with life-threatening diseases who have exhausted approved options and cannot join a clinical trial. The FDA does not approve individual federal Right to Try requests, but eligible drugs must satisfy federal criteria.

For Montana patients, the immediate consequence is limited: a privately reviewed protocol now exists, while the licensed infrastructure needed to deliver it does not. Whether the system expands access safely will depend on the state’s licensing oversight, the quality of private reviews and the reporting of patient outcomes once centers begin operating.