Important: Public Citizen\'s Health Research Group
Post# of 148166
(Total Views: 1114)
Posted On: 05/08/2021 3:38:57 PM
Hi All
I ran across this Request from Public Citizen's Heath Research Group to the FDA and CDER demanding a reconsideration of the FDA's approval of Remdesivir. Click on the PDF to see the full document, not just the press release.
https://www.citizen.org/article/letter-to-the...-covid-19/
PDF: https://mkus3lurbh3lbztg254fzode-wpengine.net...s/2578.pdf
I have not heard of this group before, but according to Public Citizen, the FDA did not follow their own guidelines and consult with the Drugs Advisory Committee prior to approval and ignored conflicting data and safety issues from other trials. If you read the attached PDF, you can see that this document goes into great detail about how the Remdesivir data was "sliced and diced" and ultimately a small subgroup was the basis for FDA approval. That in itself was very interesting, because the hedge fund naysayers have been saying for months that the FDA doesn't issue EUA's or approvals based on sub groups or cherry picked data, but that wasn't the part that intrigued me. The part that I found most interesting was the fact that the authors of this document, the research group, obviously have a deep understanding of clinical trials and approvals, and are not afraid to challenge the status quo. Their names and emails can be found at the end of the document.
Unfortunately, I'm traveling and don't have the time to fully explore and act on this, but thought I'd post it here and see if anyone else has relevant contacts, thoughts or ideas.
A few questions came to mind:
Do Senator Sanders and Rand know of this report on Remdesivir?
Has this group heard of Leronlimab? What is the most concise way to get the story of Leronlimab across to this group?
Do they know about our failure to secure an EUA despite our top notch safety record, NEWS2 scores and incredibly promising results in the critical patients?
Do Drs. Lalezari and Seethamraju know about this group and would they be interested in reaching out to them for assistance?
Thanks so much.
I ran across this Request from Public Citizen's Heath Research Group to the FDA and CDER demanding a reconsideration of the FDA's approval of Remdesivir. Click on the PDF to see the full document, not just the press release.
https://www.citizen.org/article/letter-to-the...-covid-19/
PDF: https://mkus3lurbh3lbztg254fzode-wpengine.net...s/2578.pdf
I have not heard of this group before, but according to Public Citizen, the FDA did not follow their own guidelines and consult with the Drugs Advisory Committee prior to approval and ignored conflicting data and safety issues from other trials. If you read the attached PDF, you can see that this document goes into great detail about how the Remdesivir data was "sliced and diced" and ultimately a small subgroup was the basis for FDA approval. That in itself was very interesting, because the hedge fund naysayers have been saying for months that the FDA doesn't issue EUA's or approvals based on sub groups or cherry picked data, but that wasn't the part that intrigued me. The part that I found most interesting was the fact that the authors of this document, the research group, obviously have a deep understanding of clinical trials and approvals, and are not afraid to challenge the status quo. Their names and emails can be found at the end of the document.
Unfortunately, I'm traveling and don't have the time to fully explore and act on this, but thought I'd post it here and see if anyone else has relevant contacts, thoughts or ideas.
A few questions came to mind:
Do Senator Sanders and Rand know of this report on Remdesivir?
Has this group heard of Leronlimab? What is the most concise way to get the story of Leronlimab across to this group?
Do they know about our failure to secure an EUA despite our top notch safety record, NEWS2 scores and incredibly promising results in the critical patients?
Do Drs. Lalezari and Seethamraju know about this group and would they be interested in reaching out to them for assistance?
Thanks so much.
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