Tuesday, March 22, 2022 6:19:25 PM
Seems to me the FDA is in contempt of the U.S. Congress or are they in Federal Court, again???
https://www.reuters.com/legal/government/wait-what-fda-wants-55-years-process-foia-request-over-vaccine-data-2021-11-18/
I agree, we are in a political war.
We need RLF-100/ZYESAMI/AVIPTADIL now!!
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 that 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 urgent matter.
Last Shot Hydration Drink Announced as Official Sponsor of Red River Athletic Conference • EQLB • Jun 20, 2024 2:38 PM
ATWEC Announces Major Acquisition and Lays Out Strategic Growth Plans • ATWT • Jun 20, 2024 7:09 AM
North Bay Resources Announces Composite Assays of 0.53 and 0.44 Troy Ounces per Ton Gold in Trenches B + C at Fran Gold, British Columbia • NBRI • Jun 18, 2024 9:18 AM
VAYK Assembling New Management Team for $64 Billion Domestic Market • VAYK • Jun 18, 2024 9:00 AM
Fifty 1 Labs, Inc Announces Acquisition of Drago Knives, LLC • CAFI • Jun 18, 2024 8:45 AM
Hydromer Announces Attainment of ISO 13485 Certification • HYDI • Jun 17, 2024 9:22 AM