It met the efficacy and was within the 5% band of approval for all drugs and devices. ETRM wanted super-efficacy, which is unheard of in the industry in other words within the 1% level. It is not required, anything within 5% is sufficient for FDA and fact they tried to put hurdles very high points to responsible management who wants to truly help obese people. FDA will look favorably at this try plus VVUS and ARNA do not have hypertension and diebetic benefits. This device once planted in, person goes on with normal life and no side effects, VVUS and ARNA have terrible side effects, so which would you choose.
As I said, $ 3 before FDA panel, DOUBLE on FDA panel thumbs up and then double digits heading into the FDA decision.
Any people buying now are looking for a 1000% return within 9 months to 1 year, where can you find that?