Replies to post #16811 on Titan Medical Inc (TMDIF)

[Daktari]

What's your take Belizeme?

[ORrep8]

Daktari...When I saw the initial timeline change, I cocked my head a little and then I immediately thought, this is super conservative...and it could be a way to throw off the competition. You only need to provide safety and efficacy when a similar product already exists. That timeline could be way ahead of schedule in 6 months time. I get why some people may freak out over this, but if you really take a step back and think about this the right way, you will see that this shift is the best mode of action.

[BelizeMe]

If you look back in one of my posts last week I mentioned that intuitive did not need to do human clinical trials on their new SP. They were able to use their original SP device, mostly the software as a predicate. They only were required to do bench trials, cadavers, human factor modeling, and porcine surgeries. What I am not sure is would FDA look at Titans software as needing further evaluation in human trials to verify safety, etc. Let's hope not. That could significantly move up the timelines.

BelizeMe