Actually the average for a De Novo submission to approval in 2022 was nearly 365 days. Hopefully some of the 510k submission may shorten that for Invivage. Otherwise, and my concern is, a new study, ie recruit and do a study over many months, and then submit.
As the company still has not given any guidance, I have not taken up the CR offer. As investors, we have a date that is 'some time' in the future for the device to be ready for sale. Is it likely next year, 2025, 2026?
I would hope in the annual report next month with a presentation we get one of those nice timeline charts, if not then, at the general meeting a couple of months later. Because if the studies aren't completed and submission ready for early next year, it's a 2025 story.
Tiresias: Delivery on the way, page-5
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