Titan Medical Inc (TMDIF)

[EIT]

Oh yes, it will. I'm far less worried about the next 12 months than what comes after. It's pretty much set as to what will happen in that time.

Beyond that, no-one really talks about it yet, but we have to prove clinical equivalence to a predicate device, and there's really a lot of stuff up in the air about that.

Is the predicate device single PORT and urogical indications only as per the SP of intuitive? Or is the predicate device as per multi-port and all the abdominal procedures? The FDA first and foremost wants clinical equivalence, but no-one knows anything as of yet, and what the FDA wants exactly, and what it will mean in terms of human trials required. If we do get FDA approval, I would not be surprised it will be initially for one indication only. But I'm no expert here, just going by my gut here and reading between the lines of the M&A, and anyone please show me wrong.

It's still a long road ahead till we get into the big money. But, first things first. I'm sure we'll have a nice cushion with a PPS over 10 in the next 12 months to be able to take the next blow. I can't imagine not getting the 3.20 warrants soon. Seriously, we're talking 0.10-0.11 cents here.

Have a good weekend.