$RLFTF Interesting Ya-h0 thread: Julie9 hours ago
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Posted On: 04/01/2021 4:14:57 AM
$RLFTF Interesting Ya-h0 thread: Julie9 hours ago
Per the FDA guidelines for EUA on their website: FDA is prepared to issue EUAs expeditiously (e.g., within hours or days) when circumstances warrant and adequate information has been made available
———————
c. Disposition of Requests
FDA is prepared to issue EUAs expeditiously (e.g., within hours or days) when circumstances warrant and adequate information has been made available for prior review through pre-EUA interactions. Generally, the timelines for FDA review and action on a request to issue an EUA will be determined on a case-by-case basis and will depend on factors such as:
The product profile;
The existence, if any, of pending applications for the product;
The nature of the emergency, potential emergency, or threat of emergency;
The organization and completeness of the request submission; and
The workload of the reviewing Center’s personnel.
some replies..
Max
I think we will have the EUA, but the FDA could have already give it in September, for now it has only lost 6 months of human lives
Kevin
Promising
Goose
just a question- don't you think this would have already happened if it could save lives? a long time ago?
----
Ginger
Sugar,
If their urgency didn't change with 3,000+ deaths per day, I doubt 1,000 will place Zyesami on top of the paper pile. They approved Lilly's drug and have now revoked it due to loss of efficacy against variants. They could have done the same with Zyesami with 0 risk knowing it is 100% safe and is indifferent to variants - it still works.
Just 1 life saved is everything to the family who lost that loved one. Multiply that by 1000 families each and every day. They fell asleep at the wheel while the titanic continued toward the iceberg and barreled into it. We've taken on water, but only the steerage see it for now. These new variants will continue to reduce efficacy of existing vaccines, especially the targeted mRNA ones. Mother Nature can patch the holes, you just have to let her work her magic.
Follow the money
----
My reply after 9 months is rrrrrrrrrrrr WTF !!!! I've been beyond reason for awhile now.. copy and paste man that's all... G. -ave mercy!!!!
Per the FDA guidelines for EUA on their website: FDA is prepared to issue EUAs expeditiously (e.g., within hours or days) when circumstances warrant and adequate information has been made available
———————
c. Disposition of Requests
FDA is prepared to issue EUAs expeditiously (e.g., within hours or days) when circumstances warrant and adequate information has been made available for prior review through pre-EUA interactions. Generally, the timelines for FDA review and action on a request to issue an EUA will be determined on a case-by-case basis and will depend on factors such as:
The product profile;
The existence, if any, of pending applications for the product;
The nature of the emergency, potential emergency, or threat of emergency;
The organization and completeness of the request submission; and
The workload of the reviewing Center’s personnel.
some replies..
Max
I think we will have the EUA, but the FDA could have already give it in September, for now it has only lost 6 months of human lives
Kevin
Promising
Goose
just a question- don't you think this would have already happened if it could save lives? a long time ago?
----
Ginger
Sugar,
If their urgency didn't change with 3,000+ deaths per day, I doubt 1,000 will place Zyesami on top of the paper pile. They approved Lilly's drug and have now revoked it due to loss of efficacy against variants. They could have done the same with Zyesami with 0 risk knowing it is 100% safe and is indifferent to variants - it still works.
Just 1 life saved is everything to the family who lost that loved one. Multiply that by 1000 families each and every day. They fell asleep at the wheel while the titanic continued toward the iceberg and barreled into it. We've taken on water, but only the steerage see it for now. These new variants will continue to reduce efficacy of existing vaccines, especially the targeted mRNA ones. Mother Nature can patch the holes, you just have to let her work her magic.
Follow the money
----
My reply after 9 months is rrrrrrrrrrrr WTF !!!! I've been beyond reason for awhile now.. copy and paste man that's all... G. -ave mercy!!!!
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