Titan Medical Inc (TMDIF)

[Noemotionseller]

Yes new units are needed for the final trials. What is handed to the FDA MUST be from a unit that is EXACTLY what will be sold. Our new partner is going to integrate and hopefully improve upon SPORT. This will take a year. During which they will use the current EV units to prove more they are able to apply via predicate device. I do not like the extension but too many people (new posters with agendas) are trying to make it sound like the end of days.... Yes the company should be more clear with their relationships but the FDA process is deliberate and it is going to affect all comers in the same way. Concern is one thing, but some are promoting a need to freak out and that is just not necessary.