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Re: None

Thursday, 05/12/2022 9:51:37 AM

Thursday, May 12, 2022 9:51:37 AM

Post# of 140456
Here's all you need to know. THREE more years until submission for FDA approval and how much do you want to bet that will be delayed and that deadline (like all of them to this point) won't be met. This is a POS investment run by POS managment.

The company plans to file the IDE application with the FDA in the first quarter of 2023 and anticipates receiving a response on the IDE from the FDA in the first half of 2023. Following IDE approval, Titan expects the IDE clinical study to proceed and be completed in time for submission of a De Novo classification request in 2024. Commercial launch of the Enos system is scheduled to begin upon receipt of marketing authorization from the FDA, anticipated in early 2025.