(Total Views: 830)
Posted On: 04/23/2020 1:13:35 PM
Post# of 11803
This is not a bash; rather it is something in today's News Release that has me confused. I have presented it to the other board, and I will also ask the same question here as a valid response will clear my befuddled brain.
FROM TODAY"S NEWS RELEASE
https://www.investornetwork.com/news/N-23C706...0BBE91736B
This reads that two (2) Pre-EUA submissions and numbers were granted.
If the first Pre-EUA (PEUA) issued was on April 4, 2020 and was granted PEUA200323
why does the second (2nd) Pre-EUA bear the lower number PEUA200232 ?
Unless I missed something, this is the first mention of PEUA200232.
I find this very confusing, but this could just be me. Am I reading something wrong here?
FROM TODAY"S NEWS RELEASE
https://www.investornetwork.com/news/N-23C706...0BBE91736B
Quote:
As previously stated, we were granted a Pre-UEA (PEUA) by the U.S. FDA on April 4, 2020, PEUA200323, for our GenViro! :15 Swift kit for the testing of Covid-19. The PUEA is the formal notification from the FDA that a file (product) is under review for EUA clearance, that a reviewer has been assigned, and that testing protocols have been exchanged.
Quote:
We have received the Pre-EUA Acknowledgement letter from the U.S. FDA for device (serial number) PEUA200232, GenViro Covid-19 Screening Kit.
This reads that two (2) Pre-EUA submissions and numbers were granted.
If the first Pre-EUA (PEUA) issued was on April 4, 2020 and was granted PEUA200323
why does the second (2nd) Pre-EUA bear the lower number PEUA200232 ?
Unless I missed something, this is the first mention of PEUA200232.
I find this very confusing, but this could just be me. Am I reading something wrong here?
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