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Thursday, March 10, 2022 1:19:56 PM
The Republicans are requesting answers to the following questions to better understand the FDA’s decisions regarding an EUA for ZYESAMI:
1. Please provide a timeline of FDA and NIAID actions to review ZYESAMI as an
emergency treatment for COVID-19.
2. Please provide documentation of any communications between FDA or NIAID and
physicians or hospitals that are utilizing ZYESAMI under Right to Try.
3. Has the FDA ever accepted the data of ongoing clinical trials when issuing an EUA for a
treatment for COVID-19? If so, please provide the treatment and its EUA.
4. Please explain why the FDA refuses to review ZYESAMI data until completion of a
clinical trial.
5. For COVID patients that received remdesivir and steroids but did not recover, what is the
FDA and NIAID’s current treatment recommendation?
They have asked for a response from the FDA and NIAID no later than 5:00 p.m. on March 17.
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