Titan Medical Inc (TMDIF)

[Geo2014]

Agreed that execution of strategy is paramount, but in the end it all comes down to efficacy of the product (...and hopefully little to do with "politics").

From the FDA web site...

Premarket Approval (PMA) is the most stringent type of device marketing application required by FDA. A PMA is an application submitted to FDA to request approval to market. Unlike premarket notification, PMA approval is to be based on a determination by FDA that the PMA contains sufficient valid scientific evidence that provides reasonable assurance that the device is safe and effective for its intended use or uses.