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pastrychf05

04/07/20 3:48 PM

#68070 RE: VST7 #68066

Thank you - that is great information.
Testing people with the kits has to take place and I guess if the results are accurate they will get approval very quickly ...
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Zman20

04/07/20 3:49 PM

#68072 RE: VST7 #68066

You sir are very smart and have done your DD. I couldn't stop laughing at everyone thinking approval will come this week lol. In the mean time, this is the time to sell. It'll drop massively down in the next few days
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allezlOM

04/07/20 3:51 PM

#68076 RE: VST7 #68066

DECN received the Pre-EUA Acknowledgement and device serial number on Saturday, April 4, 2020.
Meaning written few days before...APPROVAL Imminent, thanks !
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macncheese

04/07/20 3:57 PM

#68089 RE: VST7 #68066

Confirms with the timeline with them wanting to push these tests out by early to mid May. Approval for this by 3rd week of April and mass production begins and has it shipped out my mid-May is my hope/expectation.
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UP Trend

04/07/20 4:00 PM

#68091 RE: VST7 #68066

Good to know, thanks for sharing. Whales gonna have another week to load up the boat if that’s correct.. let’s also not forget this is the fastest kit in the world and they have fda counsel talking regularly with fda and getting guidance, that serial number was granted pretty quick.
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VST7

04/08/20 8:56 AM

#68397 RE: VST7 #68066

Yest.I spoke with the FDA Dept. that is in charge of new testing devices being submitted for approval under the Emergency Use Authorization law...

I told them the reason I was calling was I wanted to find out what the average or minimum time it would take for a New testing device to get an Approval/Disapproval answer from the FDA during this pandemic, their answer was Quote; "A Minimum of 2 weeks" from the day of application acceptance for new Covid-19 test devices...

I wanted to find this out since everyone seems to be expecting an approval answer/PR in the next day or two, and I wanted to hear what the FDA had to say about it.

The number I called was 888-463-6332 (pressed #1) and spoke to a woman who transferred me to the Dept that is in charge of new testing devices for the Covid-19 virus...