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Monday, 04/08/2024 5:37:49 PM

Monday, April 08, 2024 5:37:49 PM

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Versea got a few positive decisions from the FDA published today. This one for example https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/Detail.cfm?ID=40027 with WAIVED approved 4 days after the application. That would imply that Versea could submit the wavier request on Monday hours after the 10K is released and have an approval on Friday of next week that would be published by the FDA the following Monday April 22. This one as well WAIVED in 4 days. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/Detail.cfm?ID=40028 These were categorized as substantially similar SESE so they were apparently the fastest to process but it seems that the FDA is moving very rapidly these days.

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