Titan Medical Inc (TMDIF)

[Geo2014]

I agree with your statement about the FDA. I am a clinical research monitor and I contract with sponsor companies in drug and device development (primarily investigational drug) to audit data before they submit for approval. There are ALWAYS delays with the approval process. Ximedica may help to streamline the process but keep in mind the FDA is a powerful government regulatory agency. It is their job to make it difficult. On the plus side, Titan is a new company so they havent had an opportunity to get the FDA agitated. I recently posted a 483 (Warning Letter) from the FDA to ISRG... trust me, life in the regulatory department at Intuitive is no picnic now that the FDA has reason to continually audit them. The takeaway from this post? Don't be alarmed if the FDA holds up approval. It is all too common!