Sunday, August 25, 2019 11:08:50 AM
Titan has had a ton of conversations with the FDA and have been told exactly what the need to do and document for approval. I believe Titan has already delivered on 80-85% of the info that the FDA requires for approval and the final 15-20% will be completed upon human clinical trials.
The FDA approval process will be shorter then most b/c of all the documentation and discussions that have taken place. In the past, companies would do all this work and then submit all at once to the FDA which in turn they would have to take 6-9 months to review and then make a decision. In Titan's case, they have been discussing with the FDA over the last 12 months and submitting info that is reviewed by FDA that they would normally review after regulatory submittal. I am expecting quick 510k approval after submittal and FDA process to be shorter than people are expecting it to be.
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