I am certain that ETRM must have hired a bus load to bring these people in person to FDA Panel. When you have a face to the obesity problem it is pretty hard to say it doesn't work.
This does not surprise me. If you watched the video of Mark Knudson he spoke of working in an environment where he saw literally thousands of companies looking for venture capital and he knows what works and what doesn't. He said first you need to make sure that you identify a need, meaning a void to fill. The figure out how to fill this void by taking agnostic view of technology and not locking yourself into one position, then figuring out how you can attain your results and finally getting feedback from clients. He said most companies do not do this and hence fail.
He is a shrewd business man. It showed when he met FDA in May 2013 prior to filing PMA. He wanted to make sure he had the goods first. No point filing if FDA is going to say no. He worked with FDA.
The 100 + letters is simply the feedback from satisfied patients. This goes a long way to proving quality of life and efficacy vs placebo. It is the equivalent of gold. It is a good find and I am with all certainty that shorts are in hot water thanks to oozhee22 the clown.
It does appear there are 9 voting members. For some reason before I even knew this I had an instinct vote was 8 to 1 in favor. Now you tell me there is 9 members. Coincidence, don't think so.
If anyone read the FDA briefing reports one can easily determine that it must have been extremely costly and time consuming to prepare. In addition to have 14 people scheduled to hear this report and the costs associated with that. I ask myself, Why would the FDA go through so much trouble given that data did not hit primary endpoint vs placebo. You almost have to be a lunatic to act in this fashion, doesn't make sense to engage such costly procedure.
The only explanation I can find is this. FDA has seen a rise in obesity rates and knows pills do not work plus bariartic surgery gives too much complications. Hence VBLOC seems to fill a void of a safer choice. Remember the objective is to bring obesity down. The only problem is that VBLOC did not hit primary endpoint vs placebo.
The FDA therefore found itself in a delicate position. If it approves then competitors and others will claim favoritism and opens the door to everyone whether they hit protocol or not. To circle around this FDA has washed its hands by placing a FDA Panel. The FDA would use indirect tactic language to encourage approval like they missed 12 month protocol which can be explained by too high of placebo but here is 18 month data much better. It has become political.
When there is limited choices with obesity which is rising and rising, FDA needs to do something. VBLOC did drop 25% EWL vs a person who has no device and, it is safe. This counts for something. For these reasons I believe approval will be 8 to 1.
I presume you are speaking to me. I say YES vote.
Why? Because safety was met. Because FDA chose to include 18th month data. Because Obesity rates are soaring. Because FDA wants clients to have a choice.
I have always maintained it will get approved however just looking at all the possible results and all I see is RALLY in one way or another. I do not see drop or plunge. It has already done this.
Other point: At 18 months placebo regained 40% of their weight where-as VBLOC accelerated its lead to 13.5% from 8.5%. That is pretty convincing to me.
Why would FDA ask the panel their opinion as to whether the 18th month data met efficacy? It is not part of the protocol.
The FDA asked did 12th month data meet efficacy? The answer is no, we know this. The no can be explained by the higher placebo effect miscalculation. So the FDA to encourage approval puts in the 2nd question of 18th months where there is efficacy and placebo effect plunges.
Why would FDA include this? It is to steer committee towards approval. You need to show efficacy and the 18th month data did it.
Political I say, they need VBLOC to give customers a choice.
That is why they have a panel discussion. It is a discussion afterall and everything is taken into consideration. If it was only the raw data without explanation then chances are slimmer but with explanation and better understanding of both results and FDA position, it should pass.
If I were on panel, I would vote YES. Voting No when you don`t have much alternatives out there does not make sense. Also remember that VBLOC is already approved in Europe and Austrialia so they have data there too and it is safe plus effective. If it is good enough for them, it is good enough for us.
No. They already announced $ 25 million credit facilty. They will sell like you and me at much higher prices like $ 6 or $ 8 and in small shares perhaps 1 million shares per quarter. They are not stupid. All this selling based on Fear.
CHICKEN. Decisions are made on fundamentals not fear or greed. FDA wants patients to have other choices and they explain away the miss to the panel board plus included 18th month data which was not even part of the protocol. What does that tell you when they go to those great lengths. APPROVAL.
Nothing comes easy. An outright 16-0 rejection is bad. Doubt it very much, probably split down the middle either positive or slightly negative. In the end, nothing will be settled tomorrow, more questions than anything else.
I read it.
On one hand it ask does 12 month data met efficacy?
On the other it asks does 18 month data met efficacy?
One is no and other is yes.
Safety is met so no issue here.
What do you do on split data?
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.