Wednesday, March 09, 2022 8:51:41 AM
Zye of Relief 9 hours ago
My personal take on this: JJ is stepping out and NRxP focusing on the U.S. It really says mediation is going well for RT, as evidenced by the firing of Sir Bowtie and the forfieture of its claim to Canadian and Israeli territories. And now we wait,"FOR THE REST OF THE STORY" LONGER AND STRONGER EVERYDAY-1 ?? unnecessarily JJ
Bullish
Serge 1 hour ago
Robert M. Califf and Anthony S. Fauci
March 3, 2022
Page 2
Fauci
touted ZYESAMI as a promising treatment for COVID 19. 8 However, the drug remains
largely unavailable, and we are told FDA refuses to review the data of NRx’s EUA until the
National Ins titute of Health ( completes clinical trials of ZYESAMI later this year. 9
Two
years into a pandemic and with a death toll exceeding a reported 900,000
Americans, it is unacceptable that the FDA and NIAID are needlessly delaying a treatment for
late stage COVID 19 with a remarkable track record of success. This bureaucratic dragging of
your feet appears in stark contrast to the expedited review of other treatments like remdesivir,
Molnupiravir, Paxlovid and the COVID 19 vaccines. The FDA’s disparate review processes for
different treatments that appears to favor large manufacturers is troubling.
To
better understand the FDA’s decisions regarding an EUA for ZYESAMI, we
respectfully request the following information:
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 tha t received remdesivir and steroids but did not recover, what is the
FDA and NIAID’s current treatment recommendation?
Please
provide this material as soon as possible but no later than 5:00 p.m. on March 17
2022. Thank you for your attention to this ur gent matter.
Sincerely
Ron Johnson Ted Cruz
United States Senator United States Senator
8 Press
WONG 17 hours ago
It's about time.
In a recent letter co-authored by Sen. Ted Cruz and Reps. Andy Biggs and Chip Roy, Sen. Ron Johnson demands answers from the Food and Drug Administration (FDA) and the National Institute of Allergy and Infectious Diseases (NIAID) as to why they have refused to even entertain the emergency use authorization request or even review the data from ZYESAMI manufacturer NRxPharmaceuticals on its efficacy against COVID.
Bullish
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