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$2.06 emvision medical devices ltd

Out of curiosity where did you get the October FDA meeting date?

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23/07/24

20:28

Post #: 74881281
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Originally posted by vintage ↑

"Would like to think that both products would be up and running in many medical facilities within 18 months"

Would be nice - but I can't see that happening.

The meeting with FDA to finalise validation study protocols and endpoints is not until October. There may be issues raised and further clarifications required. But lets assume best case and all is good to go. So validation trial commences Nov-Dec. You would have to think the trial would be at least 6 months - maybe longer if need to recruit more than a few bleed patients. Lets assume 6 months and then 3 months to process data, then a few more months to finalise submission to FDA. That takes it to Nov-Dec 2025. FDA minimum timeline for de Novo submissions is 150 review days or 30 weeks but average is over a year, with only 1% of de Novo's having achieved the minimum timeline. Lets take Aug-Sep 2026 as a likely best case for approval. Then there is the need to scale up the manufacturing before meaningful distribution. So that means at least the end of 2026 - with the Gen 2 being 6-12 months behind, with its somewhat shorter 510K approval pathway.

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Out of curiosity where did you get the October FDA meeting date?

EMV Price at posting: $1.99 Sentiment: Buy Disclosure: Held
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