What a champion downramper!
You're wrong: MSB and then partner Cephalon taken over by Teva guided the FDA's policies on stem cell technology.
We have been the first and the FDA was feeling their way.
Suddenly the FDA changed direction and the article in Endpoints makes it clear that the reversals (including not following the advice of their own expert panels) is not a good look and not productive for the FDA.
We can expect improvement in the future. IMO.
https://endpts.com/cber-director-peter-marks-says-fda-is-growing-to-keep-up-with-cell-and-gene-therapies/
https://endpts.com/cber-chief-peter-marks-considering-clinical-hold-alternatives-as-they-put-shudders-down-investors-spines/
https://endpts.com/qa-fdas-peter-marks-ready-to-encourage-more-accelerated-approvals-for-rare-diseases/
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