Montana’s plan to become an experimental medical hub just pushed forward
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The rules took a very long time and became effective from Saturday, July 25.
60% confidenceHis vision for right-to-try was to focus more on preventative medicine rather than just treating diseases once they show up.
60% confidenceJustice saw an opportunity to help build a safe, transparent, scientifically rigorous process for implementing Montana's right-to-try legislation, especially for longevity medicines.
60% confidenceOncology and neurodegenerative disease treatments are compatible with Infinita's longevity mission; the goal is not solely to convince everyone to support radical life extension.
60% confidenceConcerned about potential harm from selling unproven treatments without FDA oversight.
60% confidenceMontana is now seen as a better model than Próspera because it builds on existing regulatory precedents.
60% confidenceMost applicant interest so far is coming from oncology and neurodegenerative disease, more than pure longevity interest.
60% confidenceMontana's law creates not just a legal pathway for patients but a viable business model for companies.
60% confidenceThe FDA is not a bottleneck but exists to ensure expanded-access programs are aboveboard and that patients contribute knowledge from their treatment.
60% confidenceIt is wrong to assume a drug is safe just because it passed a phase I study.
60% confidenceMontana's system is interesting, pragmatic, and suitable for Ceres's drug, but the company won't apply yet due to concerns it could jeopardize FDA standing.
60% confidenceThe Montana ETRB expects to begin reviewing the first submitted applications this week.
60% confidenceMontana's program allows patients access to preventive or earlier-stage interventions with informed consent, broadening the range of eligible therapies compared to expanded access.
60% confidenceWinSanTor has a newsletter reaching around 15,000 patients, many of whom may travel to Montana for access.
60% confidenceThe Montana ETRB review process will be done rigorously with qualified medical professionals and appropriate oversight.
60% confidenceThe Montana ETRB board members were selected because they were among the best people in Infinita's network.
60% confidenceCurrent FDA assurances may not hold under a future presidential administration.
60% confidenceMontana Governance Services Inc is a local Montana registered entity under the Infinita umbrella.
60% confidenceAs a matter of policy, the FDA does not comment on state legislation.
60% confidenceThe FDA approves over 99% of expanded-access applications.
60% confidence