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SkyLimit2022

12/10/22 3:37 PM

#547049 RE: dr_lowenstein #547046

100% False.

There were no other controls. It is public record. The data may be deemed supportive, but FDA approval was indeed still granted.

Show me any other controls for any of those drugs—the controls are published by U.S. law.

Even in the Pazdur article—the drug’s data were supportive and FDA approval was granted.

I named ECA approvals from memory, but then quoted excerpts from the article that you cited which named those very same drugs.

“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”


The above facts are included in the Pazdur article that you cited:
https://www.annalsofoncology.org/article/S0923-7534(22)00006-0/fulltext

Show us the other controls for any one of those drugs—there aren’t any.




Bullish
Bullish