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.
Glidelogic Corp. Becomes TikTok Shop Partner, Opening a New Chapter in E-commerce Services • GDLG • Jul 5, 2024 7:09 AM
Freedom Holdings Corporate Update; Announces Management Has Signed Letter of Intent • FHLD • Jul 3, 2024 9:00 AM
EWRC's 21 Moves Gaming Studios Moves to SONY Pictures Studios and Green Lights Development of a Third Upcoming Game • EWRC • Jul 2, 2024 8:00 AM
BNCM and DELEX Healthcare Group Announce Strategic Merger to Drive Expansion and Growth • BNCM • Jul 2, 2024 7:19 AM
NUBURU Announces Upcoming TV Interview Featuring CEO Brian Knaley on Fox Business, Bloomberg TV, and Newsmax TV as Sponsored Programming • BURU • Jul 1, 2024 1:57 PM
Mass Megawatts Announces $220,500 Debt Cancellation Agreement to Improve Financing and Sales of a New Product to be Announced on July 11 • MMMW • Jun 28, 2024 7:30 AM