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Wednesday, March 23, 2016 7:41:06 PM
I believe there is something to this FDA approval process. After the FDA symposium regarding approval process for future robotic systems, I think Titan thought the FDA would move quick in making a decision about how they wanted to approve future devices (Meeting was in June). But since gov't entities never move quickly, Titan got caught and had to do that offering last winter b/c the FDA has not decided yet. It's possible that Bertner Advisers wasn't able to bring enough investors required to fill the offering. We also know they couldn't control the shorts (per Randall's comments). IMO, this could explain the decision to bring in ECV. After the last offering, which was required to get them through clinical trials from a money standpoint, they felt good about their product to unveil it at SAGES. This time around, they are capitalizing on the buzz from SAGES and interest in investors to go to the shelf in order to prevent getting caught if the FDA continues to drag their feet. If they can get the remaining $21M in this offering, this will get them through to FDA approval with some money to meet the initial PO's from international market.
IF the FDA comes back and rules that a surgical robotic platform like SPORT will be approved on the tasks in can perform rather than the customary procedural application, then we can expect SPORT to gain CE and FDA approval by year end.
This should all become clear over the next 3-6 months b/c we will hear back from the FDA on their Surgibot decision (TRXC's IR said it was expected by end of Q1 2016 - 8 more days unless their is a delay with the Surgibot product) - that should give us insight in how the plan to approach SPORT and any future surgical robotics platform.
Another interesting note about VERB, MEDTRONIC and anyone else getting into robotics, they would also have personnel that are in tune with the FDA process and they could be waiting to see what decision is made before they jump in and purchase a platform like SPORT. My belief is that if the FDA rules on task based, then SPORT will be acquired quickly. All of this of course is just an opinion.
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