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longtermgems

11/04/14 3:17 PM

#577 RE: was CUIN2 #576

Yea and that's where I disagree with ya, Titan is farther behind and basing off of the timeline of TRXC, Titan won't be selling their product in the U.S. until 2016, mark my words!

Has Titan froze their design yet? Have they received pre filing submission feedback from the FDA? Trying to gauge where Titan is, and given that the FDA is slow and it will take 6+ months to receive 510k fda approval, I'm quite confident Titan won't be selling in the U.S. in Q4 2015. The company hasnt even said they would sell in the U.S. then.

Does Titan have to conduct a clinical trial prior to approval? I feel like the board surely thinks so. If so, that's a 3+ month delay