It is in times like this where we separate the men from the boys or, those who step up to the plate to perform.
I have not seen anything in the Fed briefing documents which has surprised me or that gives me concern. The only issue was a pleasant surprise knowing why ETRM claimed the hurdle was too high when the FDA miscalculated the placebo effect at 5% when it actually came in at 15%. The placebo effect has greater success than both the VVUS and ARNA drugs which have been approved.
If the FDA had properly put the placebo effect at 15% then the hurdle for ETRM was 10% given that they hit 25%.
In the end, common sense must prevail. Does VBLOC work or not? Anyone who says it does not has to explain how a person wearing a VBLOC device loses 25% EWL versus one who loses 0% wearing none. This is not easy to explain especially when Austrialia data shows 25% EWL at 36 months, where US data shows 25% EWL at 18 months and, where placebo group shows 40% regain in weight from 12 months to 18 months once they are told VBLOC is placebo. All the while VBLOC maintains 25% EWL right through.
In terms of safety, numbers have been met so this is not an issue.
Given limited choices and rising obesity rates I believe Fed Panel will lean towards approval.
The study had two co-primary efficacy objectives defined in terms of percentage excess
weight loss (%EWL) from implant. The objective was to demonstrate super-superiority,
which required that the lower bound of the 95% confidence interval for the treatment
difference had to exceed 10 percentage points. This differs from a conventional test for
superiority where the lower bound only has to be greater than zero. The study was powered
assuming a mean 25% EWL in the VBLOC group and 5% EWL in the sham control group at
12 months. The second efficacy objective was to demonstrate that at least 55% of VBLOC
subjects achieved at least 20% EWL and 45% of subjects achieved at least 25% EWL.
In the ITT-LOCF population at 12 months, the VBLOC group achieved a mean 24.4% EWL
compared to 15.9% EWL in the sham control group with a treatment difference of 8.5
percentage points (95% CI: 3.1 to 13.9). The study demonstrated superiority of VBLOC over
sham control, however the super-superiority objective was not met. While the VBLOC group
achieved the mean %EWL assumed in the study design, the sham control weight loss was
three times greater than anticipated in the study design. The majority of subjects in the
VBLOC group (52.5%) achieved a clinically significant 20% EWL and 38.3% achieved at
least 25% EWL, which slightly missed the performance targets.
The primary safety endpoint of the ReCharge Study was the rate of device, procedure, or
therapy-related serious adverse events (SAEs) in the group receiving active VBLOC therapy
at 12 months. The objective was to demonstrate a primary safety SAE rate less than the 15%
ReCharge met its primary safety endpoint with a primary SAE rate of 3.7% (95% CI: 1.3% to
Thanks for that summarizing post. Personally, if one simply asked any person on the street if they believed that the FDA would approve a product for obesity that works in 25 percent of recipients with no safety issues , they would all answer Yes. Also, Northland Capital in Minneapolis is the firm located closest to the Mayo Clinic, where they have, to the best of my knowledge, been supporters of the device for some time. Northland has a buy and a 7 dollar target on ETRM. Sometimes a question must be viewed in the most basic way, and leaving out "sham devices" and "co morbidities" the device would seem to be effective on 1 out of 4 that use it and not only presents with no safety issues, but the company will be able to present some positive "side benefits." I have no idea if the Adcom will vote Yay or Nay, but the risk reward at this point makes me just have to punch in a buy order!
I agree with your statement ADE, but enough of the unnecessary pumping you just did that if we have a no vote, we will still rally. I think we will get a strong yes, it's just a matter of should I add more before trading session ends today or stay with my current position. I'm excited for tomorrow.