MESO Nasdaq update, page-5746

So on point, @Phaedrus

Picking up on the FDA’s Regenerative Medicine Advanced Therapy framework unveiled by then FDA Commissioner Gottlieb in November 2017, well regarded Fierce Biotech had the following to say. I suggest that the promise raised in the speech has, since the creation and better resourcing of the OTP last year including Dr. Verdun’s appointment, been given a far better chance of being fulfilled. The agency did also carry out its threat, also highlighted below, of cleaning up the industry in some warning letters issued to questionable operators. This industry backdrop is likely the most supportive in years for the company’s acute SR aGVHD application.

https://www.fiercebiotech.com/biotech/building-cures-act-fda-lays-out-cell-therapy-fast-track-regenerative-medicine-framework

“The FDA has created a policy framework for cellular therapies and other regenerative medicines by releasing two draft and two final guidance documents. Publication of the texts builds on the 21st Century Cures Act by setting criteria for the new Regenerative Medicine Advanced Therapy (RMAT) designation and outlining the benefits of the regulatory status.

Given two of the documents are finalized versions of existing texts and a third seeks to simplify the regulation of devices that enable regenerative treatments, the RMATu guidance (PDF) is the novel part of the framework for drug developers. In the guidance, the FDA takes the RMAT status created by the 21st Century Cures Act, contextualizes it against other regulatory designations and explains how and why companies may want to apply.RMAT is open to investigational regenerative medicine therapies that treat, modify, reverse or cure serious conditions and have generated promising preliminary clinical evidence of efficacy. The FDA cites a single-arm, open-label study of a skin burn cell therapy and a phase 2, dose-finding trial of a heart failure regenerative medicine as examples of the types of experiments that could provide preliminary evidence of efficacy.…

Alongside all the promise, we’ve also seen products marketed that are dangerous and have harmed people,” Gottlieb said in a statement. “With the policy framework the FDA is announcing today, we’re adopting a risk-based and science-based approach that builds upon existing regulations to support innovative product development while clarifying the FDA’s authorities and enforcement priorities.”