It is always halted on the day of the VOTE. Where do you people come from. No wonder all this selling from people not even understanding the basics of the process.
The FDA is pushing for approval or faced with becoming even more concerned with rise in obesity rates.
When you sell at $ 10 and your reality is $ 2.50 will you give me the $ 7.50 in excess or be a hypocrite and keep the rest? Keep your word!!!!
Has anyone bothered to READ before they sold? Very bullish report as FDA is going out of their way to explain. ETRM has to say nothing as FDA already has provided the explanations.
I read the FDA briefing documents again and of interest,
a) FDA is asking panel to consider whether 18th month data supports efficacy? This was not part of protocol.
If you remember the 18th month data was very bullish.
b) FDA explains that part of not hitting the 10% rate at 12 months was due to higher placebo assumption which would explain why company did not hit numbers.
Again, this is FDA providing explanation to panel and not from the company.
c) FDA mentions that ETRM will conduct a 5 year follow-up study if approved, for safety and efficacy
Again from FDA to provide assurances that further work will be done.
d) FDA mentions that obesity patients need other choices as stomach staple surgery although effective has too many serious side effects.
FDA goes out of its way to mention serious side effects for stomach staple surgery.
This report is very detailed and I just don`t see how common sense will not prevail at this meeting. FDA said obesity is a serious concern and patients need other choices. What does this lead to?
I presume Ernest Marmer is writing another article for seeking alpha today for release at 3 pm saying that safety rate is 3x higher than previously disclosed and forced by FDA to release it to the panel.
Stock is priced for FAILURE...how much worse can it get!!! People will turn the page and look forward to FDA approval despite what panel says as FDA is seriously concerned with rise in obesity rates.
They will try to do what they can.
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.
Pretty incredible that people are selling with such a low market cap. Where is the RISK when market has you valued for FAILURE? It would be different if we traded on a $ 1 billion market cap expecting approval and sales.
You will be greatly REWARDED. I have not SOLD one single share. They did such a good job bashing this last week which to me confirms how afraid they were otherwise no bashing needed, results would speak for themselves.
Selloff is overdone, no matter the outcome. I actually believe that we will rally on a NO vote as investors look forward to FDA approval which is most certainly assured. It is this vote which counts the most.
Just saying we will RALLY no matter the OUTCOME....fear selloff has been overdone. FDA will approve this in 3 months regardless of panel vote.
He did a terrific job of bashing. He got you to sell your position without their even being a vote. Image that he got you to sell on the fear factor and not on a negative panel vote.
It is almost like getting a couple divorce because you get one to believe that the other is cheating when they are not or before medical testing.
Why do I say this? The selloff of late has removed all the risk, there is 0 left.
A No vote will trigger a RELIEF RALLY as investors will look forward to a positive FDA vote in 3 months.
i am confused, are you are voting member on the panel?
So you are stating your opinion. For the the titles you claim to have you will look like a complete idiot if it gets approved. I guess if that is the case retired you are and retired you will stay.
Possible given limited choice in obesity market, great safety data, great side benefits in terms of diebetic and hypertension reduction and, very good EWL numbers (24% vs 0% for those wearing devices to those with no devices).
Vote: 16-0 in favor.