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SkyLimit2022

12/06/22 9:20 PM

#544946 RE: dr_lowenstein #544935

Thank you for asking!

FDA Guidance September 2022

https://www.fda.gov/media/124795/download


There are lots of recent publications referring to the regulatory evolution toward better and more feasible trial designs.

https://media.nature.com/original/magazine-assets/d41573-020-00146-5/d41573-020-00146-5.pdf

https://www.annalsofoncology.org/article/S0923-7534(22)00006-0/fulltext

Bullish
Bullish