NorthWest Biotherapeutics Inc (NWBO): Yes, that is a quote from the article, y...

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SkyLimit2022

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SkyLimit2022

Re: dr_lowenstein post# 546812

Friday, 12/09/2022 11:50:21 PM

Friday, December 09, 2022 11:50:21 PM

Yes, that is a quote from the article, yet drugs have been approved having only ECAs. In that very same article, they named several of those drugs that I had mentioned. If I recall, the ECA data were deemed supportive, and FDA approval was indeed still granted:

“Blinatumomab was granted accelerated approval for the treatment of adults and children with B-cell precursor (BCP) acute lymphoblastic leukemia.”

“In April 2020, the FDA approved selumetinib for pediatric patients, 2 years of age and older, with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas”

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

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