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Re: Honeycomb777 post# 38741

Wednesday, 05/25/2016 9:36:57 AM

Wednesday, May 25, 2016 9:36:57 AM

Post# of 140474
Considering the devastation which the FDA brought to the Surgibot program, I don't really find fault with the revised schedule. It looks to me as if Titan has learned something from their competition's errors and is being proactive by working with the FDA. The new FDA guidance on Human Factors Engineering wants to see 15 monitored user "trials" in the US on final hardware. This will require training 15 surgeons, presumably some with da Vinci experience and some without, then running the HFE studies while they use the device. I presume their consultation with the FDA and their knowledge of the Surgibot situation has put them on a better track to success, albeit with a bit of re-design and hence delay. I don't blame the FDA for issuing guidance to make medical devices safer, and I don't blame Titan for reacting quickly when Trixie crashed and burned (I nickname my ticker symbols - ISRG is Izrag, TRXC is Trixie, TITFX is too off-color to print but fun to say out loud!)

I do find a three month Longtai delay to be interesting but not necessarily disconcerting. Longtai should now be thinking that with the delay, their investment will be less of a gamble for them. And getting their infusion of cash sooner than a one-year delay will benefit us bagholders/stockholders, depending on your point of view.

I'm starting to believe the biggest threat to the success of the program is us. There is a lot of chatter here about lawsuits which would have the capacity to shut the program down. I think there's an old expression about shooting off your nose to spite your face. The AGM appears to be a good forum for us (I wish I could go) to voice our opinions and hopefully receive logical, rational replies to alleviate our concerns. As a team effort, we should consider using this forum to coordinate our ideas and questions, keep a running list of ideas to present at the AGM, and those who can attend can present them at that time. We have a month to prepare for this and I suggest we use it wisely.

My two cents. Hopefully it's worth at least that much.