Agreed, but effectiveness is measured at 12 months post treatment, so the speed of recruitment is key. If Surgcenter with spine being one of its main service lines could be leaned upon with that process, it would be a great outcome. Surgcenter sold around 150 ambulatory surgical centres or ASCs to USPI, a subsidiary of Tenet Healthcare in 2021 and had committed to develop another 50 more under the sale agreement. Tenet would own around 440 such centres around the country apart from its hospitals. Don’t forget, Dr. Grorge is now the largest shareholder and Surgcenter has a representative on the board.
With the RMAT designation, accelerated approval is possible either with a surrogate endpoint OR reliance on data from a large enough number of sites.
I can’t imagine the company not having become smarter with the way it runs these trials, or with working out the shortest possible way to approval.
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