Titan Medical Inc (TMDIF)

[Bristol19]

CE mark and FDA approval take a long time, even after initial submissions of material. How many iterations of approval paperwork, revisions, explanations, calls for additional data etc., will need to happen. I think if today it was announced it was design frozen, then if we have the submission ready (thousands of pages of documentation), you thing CE and FDA turns this stuff around overnight?

I know companies gave up on simple clinical test equipment getting FDA approval because it took so long as was so expensive. One mistake and you are screwed for more time and money.

Where are we in the pre-approval process? Has Titan given us a timeline or status? I am not sure we are even ready to begin yet. Last thing I heard we were dealing with a change on pedals and software; is that finished? They don't have their Engineering VP to be overseeing this process yet either.

I'm just pointing out that unless all this is being kept under wraps by management, I (we) don't know a thing, except we better hurry up.