Rubraquercus, Thank you for bringing this up.
Post# of 154120
(Total Views: 537)
Posted On: 04/11/2020 8:11:56 AM
Re: Rubraquercus #26888
Rubraquercus,
Thank you for bringing this up.
I am sure Nader is aware of the EUA legislation in reference to Pandemics and, therefore, his application for emergency approval.
Due to the number of daily casualties it was the right and humanitarian thing to do.
Under the emergency authorization chapter of PAHPRA:
FDA may then issue an EUA for a product if FDA finds that:
The agent specified in the declaration of emergency can cause a serious or life-threatening disease or condition;
If there is an occasion where an emergency approval under the pandemic chapter is granted, this is it.
So, the ball is in FDA's court. I personally have my doubts about FDA scientific "purity" (and detachment form BP) I hope I am wrong, however CYDY did the right thing: apply for it. When everything is said and done at least we did not sit in our hands with a cure while people out there where perishing in droves.
We tried.
Thank you for bringing this up.
I am sure Nader is aware of the EUA legislation in reference to Pandemics and, therefore, his application for emergency approval.
Due to the number of daily casualties it was the right and humanitarian thing to do.
Under the emergency authorization chapter of PAHPRA:
FDA may then issue an EUA for a product if FDA finds that:
The agent specified in the declaration of emergency can cause a serious or life-threatening disease or condition;
Quote:
Based on the totality of scientific evidence available, it is reasonable to believe that the product may be effective in diagnosing, treating, or preventing the serious or life-threatening disease or condition, or a serious or life-threatening disease or condition caused by a product authorized approved, cleared, or licensed by FDA for diagnosing, treating, or preventing the disease or condition;
The known and potential benefits of the product outweigh the known and potential risks of the product when used to diagnose, prevent, or treat the serious or life-threatening disease or condition, taking into consideration the material threat posed by the agent or agents identified in a declaration by the DHS Secretary, if applicable;
There is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such serious or life-threatening disease or condition; and
In the case of a determination by the Secretary of Defense regarding risk to U.S. military forces from agents other than chemical, biological, radiological and nuclear agents, that the request for emergency use is made by the Secretary of Defense.
If there is an occasion where an emergency approval under the pandemic chapter is granted, this is it.
So, the ball is in FDA's court. I personally have my doubts about FDA scientific "purity" (and detachment form BP) I hope I am wrong, however CYDY did the right thing: apply for it. When everything is said and done at least we did not sit in our hands with a cure while people out there where perishing in droves.
We tried.
(5)
(0)