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SkyLimit2022

12/06/22 8:45 PM

#544923 RE: dr_lowenstein #544919

Thanks for asking about this—yes, it absolutely is new guidance! It’s a lot to read, but I wanted to provide the full-context link. Here is one relevant excerpt:



https://www.fda.gov/media/155273/download

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

https://www.fda.gov/media/155273/download
Bullish
Bullish