Replies to post #11139 on Titan Medical Inc (TMDIF)

[Bristol19]

Agreed. Should have realized that.

[Lurker05]

Phiberglass, do you (or anyone else) have a good understanding of clinical trials and FDA approval?

I am wondering how the two are related and differ. For example, if as you say a clinical trial requires 1, 2, 3 yr follow ups, I am assuming that does not relate to FDA approval. Otherwise Titan wouldn't have their FDA approval date estimated at the end of 2015 if it took a full 3 years.

Does only the first yr of trials need to be fulfilled before FDA approval and then the additional years are supplemental? Tried searching the FDA site to get an understanding timeline, but it doesn't state it clearly.