Replies to post #96111 on Titan Medical Inc (TMDIF)

[RockoTaco]

I am right, thank you for acknowledging that. To elaborate, Titan can submit IDE application on Oct 1 and the FDA can approve it on Oct 2 - that is less than 30 days away.

Upon receipt of an IDE application, sponsors are notified via email of the date that FDA received the original application and the IDE number assigned. An IDE application is considered approved 30 days after it has been received by the FDA, unless the FDA otherwise informs the sponsor via email prior to 30 calendar days from the date of receipt, that the IDE is approved, approved with conditions, or disapproved. In cases of disapproval, a sponsor has the opportunity to respond to the deficiencies and/or to request a regulatory hearing under 21 CFR Part 16