RE: Awaiting approval12 Aug 2021 14:06
I don't think we will get any news now till end of Sept/Oct ... see quote from DB from last RNS below.
Also there are 100's of other companies awaiting FDA approval therefore it would be impossible to know when GDR get notified. See quote from FDA
My only concern here as time drifts along to end of Oct. funding is going to be an issue as there is no way distribution will happen prior to then.
ALDYOR
Quoted from FDA listings which GDR are shown.
The commercial manufacturers listed below have notified FDA that they have validated and intend to distribute diagnostic test kits as set forth in Section IV.C of the FDA's Policy for Coronavirus Disease-2019 Tests. Where the Authorization Status is "FDA Authorized," the FDA reviewed and issued an EUA for the test after notification was given. Where the Authorization Status is shown as "Not FDA Authorized," the FDA has not yet reviewed the manufacturer's validation and issued an EUA for the test, and the test is included in this list to provide transparency regarding the notification submitted to FDA. The "Setting for Use" designation of "H" refers to a laboratory certified under CLIA to perform high-complexity testing. Certain developers have completed the EUA process prior to offering a test for clinical use rather than notify FDA under this policy. Tests that have been issued an EUA can be found on the EUA page.
If an EUA request is not submitted within a reasonable period of time, or if significant problems are identified with a test and cannot be addressed in a timely manner, the FDA intends to remove the manufacturer and test from this list, would expect the manufacturer to suspend distribution and conduct a recall of the test, and may take additional actions as appropriate.
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