Cell Therapy News/Articles, page-5475

From Scott Losermann's latest document.

"Moreover, although FDA approved Jakafi in 2019 for treatment of SR-aGVHD in adult
and pediatric patients 12 years and older based primarily upon the results of a pivotal, single-arm
clinical trial, this precedent cannot be applied to remestemcel-L. FDA accepted the results from
the single-arm clinical trial as the sole basis of efficacy only after considering several regulatory
factors regarding SR-aGVHD and prior clinical experience with Jakafi. Specifically, the FDA
reviewers explained that such reliance was appropriate “where the disease is life-threatening, there
are no approved therapies and no optimal therapy identified, the efficacy endpoint is objective, the
activity of the drug is established in other diseases, and there is a substantial safety database ….”27
Significantly, several of these factors clearly do not apply to remestemcel-L."

I agree to now get rid of Jakafi and replace it with a better efficacious treatment. Great suggestion Scott!!