Titan Medical Inc (TMDIF)

[66Mustang]

I wonder if IDE approval will be enough to jump start this thing...

They've been working with the FDA for at least a couple years now so both sides understand the expectations. It is not inconceivable that the IDE comes back approved very quickly instead of the max allowable 30 days, given the history of interaction between the two organizations (Titan and FDA).

IDE approval should mean the FDA is at least convinced of some substantial level of safety and presumably also efficacy before granting the IDE.

Also, coincidentally (or not!), Columbia University is a viable IRB organization for single site or multi site studies (we have up to four sites to utilize) and Dr. Advincula hangs out at Colombia and hopefully will be involved in our IRB process.

We are so freakin' close...