Surgibot Plan To Market
As investors of TransEnterix Inc (TRXC) we would like more transparency with the company. It has been a month since the last conference call and we would like the company to update it's position with regards to the Surgibot via an Investors' conference.
Questions to address:
1. Has a meeting with the FDA been met and more specifically what the reason was for the rejection that Surgibot did not meet the SE? Given that TRXC submitted the necessary documents to the FDA at their guidance, was there a part of the data that was the primary cause for the rejection?
2. Can it be remedied or does a new process must be done and what is that new application? ie. 501k or DeNovo or PMA?
3. What is the time frame that the company expects to get the FDA's approval on Surgibot?
4. From a tactical marketing point, would it not be more advantageous to push for the Surgibot into the US market instead of Alf-X because it is a much cheaper system that DaVinci cannot compete against rather than putting the priority on Alf-X?
Thank you on behalf of your investors.