Right to Try

Universal Right to Try with Evidence

Treatments arrive 181 years sooner.

If all 50 states adopt a licensed-center model that lets post-Phase-1 treatments finance their own evidence, the paper’s conditional estimate is a 5.48× discovery-rate shift — not a promise that passing a law saves anyone by itself.

Premature deaths prevented
9.19 billion

Lifetime total across future generations

Healthy years restored
483.28 billion DALYs

Schedule shift applied to avoidable global burden

Campaign + registry / DALY
$0.000134

Launch cost only — not treatment delivery

Open the impact lab

The short version

Access with evidence, not access instead of it.

About 6,650 rare diseases still have no effective treatment. At the current rate, roughly 15 receive a first treatment each year. Exploring that queue takes ~443 years; the average target waits ~222. The shortage is not of possible treatments. Many post-Phase-1 compounds, repurposed drugs, combinations, and doses are never tested because nobody can finance conventional Phase 2 and 3 trials.

Universal Right to Try with Evidence changes the financing constraint. Licensed centers provide eligible experimental treatments while patients or payers cover treatment-related care, trial-site services, and permitted study costs. Participants follow shared protocols; other eligible uses contribute separately labeled observational outcomes. State law does not waive federal authorization or evidence requirements.

If all 50 states adopt the framework and it produces the modeled increase in treatment discovery, first treatments arrive ~181 years earlier. That schedule shift is the source of the headline health totals.

Impact lab

Change the inputs. Watch the schedule shift.

The paper compresses the whole policy mechanism into one uncertain discovery multiplier, then applies the resulting years-earlier figure to avoidable global disease and aging burden. Move the levers; the arithmetic is the same.

States adopting

Multiplier increment scales with 50/50.

50

Click a tile to adopt or drop a state. Montana is ringed — it already licensed experimental treatment centers.

5.48×

Paper central 5.48× (range 1.1–15). Calibration, not an observed estimate.

92.6%

Share of global disease and aging DALYs/deaths that a completed therapeutic frontier would prevent. Paper 92.6%.

15

Status-quo pace of first effective treatments. Paper 15 (range 8–30).

100.0%

Your odds of full adoption plus the modeled discovery-rate shift. The paper leaves this outside the model.

Effective multiplier

5.48×

Years earlier

181 yr

Lives (conditional)

9.19 billion

DALYs (conditional)

483.28 billion

Suffering-eq. hours

1.65 quadrillion

Campaign + registry

$65 million

Cost / DALY

$0.000134

Cost / life

$0.00707

The queue

Most diseases still wait centuries.

About 6,650 rare diseases have no effective treatment. At roughly 15 first treatments a year, clearing that queue takes ~443 years, so the average target waits half of that. Speeding discovery does not invent new burden — it moves the first effective treatment earlier.

Average years to first treatment

Untreated diseases

6,650

95% of ~7,000 rare diseases

Current first treatments / yr

15

Status-quo discovery pace

Queue, status quo

443 yr

Diseases ÷ current rate

Queue, modeled

81 yr

Diseases ÷ accelerated rate

Average wait now

222 yr

Half the queue

Average wait modeled

40 yr

Half the new queue

Years pulled forward

181 yr

avgWait × (1 − 1/m)

New first treatments / yr

82.2

5.48× the current pace

Uncertainty

Ten thousand draws, one honest range.

The paper’s Monte Carlo samples the multiplier, launch cost, avoidable burden, and upstream inputs. It does not sample political adoption risk or model-form error. Histogram on the left; the line on the right is the chance the outcome is at least that large (1 − CDF).

Histogram

CDF line

Chance the result is at least this large

Dashed marks are the paper’s 5th / median / 95th. Solid white is your current lab scenario (9.19 billion). The line is 1 − CDF — the chance a draw is at least that large — matching the original analysis.

Baseline
9.19 billion
Mean
9.4 billion
Median
8.82 billion
Std. dev.
4.13 billion
90% range
3.71 – 17.2 billion

What the legislation changes

Montana opened the door. Evidence has to walk through it.

Senate Bill 535 lets licensed experimental treatment centers offer post-Phase-1 therapies, charge a $10,000 application fee and $5,000 renewal, and send 2% of net profits to access for qualifying residents. The rules require tracking — and explicitly say the centers do not administer clinical trials. Observational signals without a comparison cannot show that a treatment caused the result. The model bill adds four duties.

  • Enroll

    Register a prospective protocol, obtain informed consent, report serious safety events, and place each patient in the applicable federal trial or treatment-access pathway.

  • Compare

    Prespecify outcomes. Use simple randomization or another adequate control when feasible. Without an adequate comparison, label the result a signal — not a validated treatment effect.

  • Pool

    Send standardized, de-identified baseline and outcome data to a shared registry so every licensed center feeds one learning system instead of fifty silos.

  • Publish

    Continuously publish results for each treatment–condition pair, including negative and harmful results. Every use should improve the next treatment decision.

Why unfunded treatments matter

The bottleneck is finance, not ideas.

A candidate can finish Phase 1 and still be commercially impossible to develop. Conventional Phase 3 runs about $41,000 per participant. An embedded pragmatic trial can drop that near $929 — a 44× reduction for studies that can ride on routine care. Complex, high-risk work still needs specialized sites.

Cost per trial participant

Trial-cost reduction

44.1×

$41,000 vs $929 is the paper’s central pair (ranges $20k–$120k and $97–$3,000). Additional candidates — doses, combinations, subtypes — raise the chance the first hit arrives sooner. They do not multiply disease burden.

Campaign + registry

$65 million

Cost / life

$0.00707

That is launch cost divided by conditional lives, not the price of treatment. Patients or payers cover delivery. Cost per healthy year in this scenario: $0.000134.

The calculation

One schedule shift, five steps.

The rare-disease queue is the clearest available count of conditions still awaiting a first effective treatment. The model uses it as a proxy for exploring the wider therapeutic frontier, then applies the resulting years-earlier figure to eventually avoidable global burden. That proxy is the model’s strongest assumption.

  1. 01

    How long does the remaining treatment queue take at the current rate?

    6,650 untreated ÷ 15/yr

    Paper central 443 years (90% range 255–841).

    443 years

  2. 02

    How long does the average therapeutic target wait?

    443 ÷ 2

    If discoveries arrive uniformly, the average wait is half the clearance time. Paper 222 years.

    222 years

  3. 03

    How much earlier does treatment arrive at the modeled discovery rate?

    222 × (1 − 1/5.48)

    Partial state adoption scales the increment from 1× toward the full-adoption multiplier.

    181 years earlier

  4. 04

    How many global healthy years does that schedule shift restore?

    2.88 billion DALYs/yr × 92.6% × 181 yr

    Same structure for deaths: 150,000 disease/aging deaths per day × 365 × years × avoidable share.

    483.28 billion DALYs

  5. 05

    What is the campaign and registry cost per restored healthy year?

    $65 million ÷ 483.28 billion DALYs

    Campaign scales with states; the $50 million registry is shared. Treatment delivery is paid by patients or payers, not this numerator.

    $0.000134

Effective multiplier in this scenario: 5.48×. Lives: 9.19 billion. Disability-equivalent hours: 1.65 quadrillion (YLD share × 8,760 hours/year — not a claim that every hour is maximum pain).

What the dollars are

Launch cost is small. Treatment delivery is not in the numerator.

The $65 million figure is a 50-state campaign plus a shared registry’s first ten years. It is not a claim about who writes the check, and it is not the cost of giving patients the treatments. Patients or payers cover care, trial-site services, and permitted study costs. Centers then sustain the registry. The model does not require a new state appropriation.

In the cost-per-DALY numerator

  • 50-state campaign (~$15 million at full adoption)
  • Shared registry, first ten years (~$50 million)
  • Common evidence standards

Paid separately

  • Treatment delivery, paid by patients or payers
  • Licensed treatment and pragmatic-trial sites
  • Manufacturing, distribution, and post-Phase-1 assets
  • Review, compliance, and payer contracts tied to evidence

Whether those separate cash flows are lawful and large enough to sustain the modeled discovery rate is an open question — charging rules, demand, reimbursement, liability, and protocol quality all have to hold.

The federal boundary

States cannot approve drugs.

State legislation does not waive federal trial authorization or lower FDA’s evidence standard. Federal Right to Try is limited to eligible patients who cannot join a clinical trial of the drug. A patient in an interventional pragmatic trial must sit under an IND or another FDA-authorized pathway.

FDA’s bar remains substantial evidence from adequate and well-controlled investigations. Guidance already allows streamlined randomized trials integrated into routine practice (Project Pragmatica is the oncology illustration). Those programs reduce collection burden. They do not let states bypass federal law.

Medicare’s Coverage with Evidence Development is the closest payment analogue: cover specified services inside an approved study, then reconsider using the results. Universal Right to Try with Evidence applies that idea outside Medicare.

Montana can prove it

One working state is a template.

Montana already built the licensed-center and independent-review frame. Infinita stood up the first private Experimental Treatment Review Board and describes a coordinated pathway of review, licensed administration, monitoring, evidence generation, and early commercialization for post-Phase-1 therapies.

The next step is a transparent demonstration: interoperable enrollment, credible comparisons, pooled outcomes, documented fees, and safety monitoring. If that system produces useful evidence while remaining commercially sustainable, other states have something they can copy.

Original Right to Try spread from one state in 2014 to 41 by 2018. That is a distribution channel, not a guarantee. The evidence amendment has to prove its value in operation. Enroll, Compare, Pool, and Publish turn 50 access experiments into one learning system.

How to go faster

Montana is already moving. Capital is how the template spreads.

The 181-year schedule shift assumes a mature 50-state system. Infinita is the operator that actually stood up Montana’s first private Experimental Treatment Review Board, is recruiting clinics, and is asking post-Phase-1 sponsors to submit. That live stack is what other states would copy. Money into the clinics, manufacturing, and companies using the pathway is one lever — not a charity pitch, and not a button on this page.

01 · Use the pathway

Submit a therapy or license a center

Eligible post-Phase-1 treatments go to the Montana ETRB — a private board run by Montana Governance Services Inc. under the Infinita umbrella, not a state agency. Reported review fee: $12,500. Licensed experimental treatment centers then administer. Two applications (neuropathy and hearing loss) were already in as of late July 2026.

02 · Capital

Infinita VC / Infinita Fund

Infinita VC is a seed fund based in Próspera. Typical startup checks are reported around $50k–$200k. The thesis is companies that use startup-city and state-level pathways — including Montana SB 535 — to get post-Phase-1 therapies into patients and generate evidence earlier. That is the commercial layer the cost-per-DALY numerator does not include.

There is no public retail offering here. If you are an accredited investor, inquire with the fund. This page is not an offer to sell securities.

03 · Copy the statute

One working state, then 49

Original Right to Try went from one state in 2014 to 41 by 2018. The evidence amendment has to prove commercial and scientific value in Montana first — interoperable enrollment, credible comparisons, pooled outcomes, documented fees, safety monitoring. Infinita also lists active pathways in New Hampshire (HB 701-FN) and Próspera, with the Bahamas pending.

Podcasts

Recent conversations with Infinita’s founder and U.S. lead on how SB 535 actually works — who pays, what the board reviews, and why federal Right to Try barely moved because biotechs could not charge.

Official links

Read this first, actually

The numbers are conditional. The caveats are not optional.

Headline figures assume all 50 states adopt and that the mature system produces the modeled discovery rate. They are still the right objects to argue about — once the assumptions are on the table.

Sources

The analysis this explorer follows.

Parameters, intervals, and the 10,000-draw Monte Carlo are from Sinn’s Universal Right to Try with Evidence impact analysis. This site recalculates the same identities as you move the levers.

  1. 1NIH Common Fund. NIH pragmatic trials / HCS Research Collaboratory (2025).
  2. 2Sertkaya et al. Key cost drivers of pharmaceutical clinical trials in the United States. FDA study via NCBI.
  3. 3Sinn, M. P. Right to Trial & FDA Upgrade Act (2025). doi:10.5281/zenodo.19076852.
  4. 4Montana 69th Legislature. Senate Bill 535: experimental treatments (2025).
  5. 5Montana DPHHS. MAR notice 2026-427.2, experimental treatment center rules (2026).
  6. 6U.S. FDA. Right to Try eligibility.
  7. 7U.S. FDA. Demonstrating substantial evidence of effectiveness (2026).
  8. 8U.S. FDA. Integrating RCTs into routine clinical practice, draft guidance (2024).
  9. 9U.S. FDA. Project Pragmatica (2025).
  10. 10U.S. FDA. Charging for investigational drugs under an IND (2024).
  11. 11CMS. Medicare Coverage with Evidence Development (2024).
  12. 12Sinn, M. P. The Continuous Evidence Generation Protocol (2025). doi:10.5281/zenodo.18203375.
  13. 13Infinita. Bridging the gap from biotech to clinic — Montana SB 535 pathway (2026).
  14. 14Goldwater Institute. Alaska becomes 41st state to enact Right to Try (2018).
  15. 15Montana Experimental Treatment Review Board. Independent private review under SB 535 (2026).
  16. 16Infinita VC. Seed fund backing companies that use startup-city and state regulatory pathways.
  17. 17Regalado, A. Montana’s plan to become an experimental medical hub. MIT Technology Review (30 Jul 2026).
  18. 18Koka, A. & DiGiorgio, A. Right-to-Try 2.0: Inside the Montana Model with Niklas Anzinger. The Doctors’ Lounge (11 Aug 2026).
  19. 19Anzinger, N. & Martin, S. The Ultimate Guide to Montana SB 535. Infinita City Times Ep. 114 (14 Aug 2026).

Full parameter appendix: rtt-impact.acceleratedmedicine.org/knowledge/appendix/parameters-and-calculations