Cell Therapy News/Articles, page-17521

https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/important-patient-and-consumer-information-about-regenerative-medicine-therapies

This was issued in 2021. Note that it was during the height of Covid, where the agency and the country were both struggling to keep up with things. We are now in 2024 when the FDA commissioner has been talking about beefing up resources to support better systems so they can approval drugs for rare diseases faster, among other things that the agency is doing.

When the commissioner was going through the US senate confirmation hearing (his job interview essentially) a couple of years ago, he was grilled on America’s opioid problem, which he had an earlier experience of, in a previous stint at the FDA. It was almost a stumbling block to him being confirmed. It goes without saying that his position brings with it an expectation to solve these societal problems, for which a potential solution like Rex he cannot be unaware of, through his staff’s involvement in approving the design of the company’s trial for CLBP, which accounts for 50% of opioid use.