The fact that ETRM sat down with FDA discussing their clincial results with them prior to filing their PMA application for this device confirms the FDA is receptive.
The fact the FDA has informed ETRM of a FDA Panel is simply to shift the responsability to a group of Doctors whom will recommend approval so FDA does not have to hear of favoritism with present clinical results.
There is tremendous pressure in the US to reign in health care costs and obesity is a huge one costing $147 billion per year. Diet pills do not work over the long term, if they did, there would not be an obesity problem today.
VBLOC reduced average weight loss by 24% which is very good, there were also excellent benefits for diebetic and hypertension. In Australia this device has been approved and they work closely with FDA.
I believe this is a slam dunk deal for FDA really needs help with obesity problems. If VBLOC can bring the cost of $ 147 billion per year even by 10% it will be worth it.
69% of the US is overweight to obese meaning 227 million people is TARGET MARKET.
If VBLOC gets even 1/10 of 1% or .001 of this market, we are speaking of 227,000 patients per year.
If each device retails for $ 5,000 you are speaking of $ 1 billion per year in revenue.
My figures of .001 of the market are so conservative there is no way I can go lower and it still yields $ 1 billion per year in revenue. ETRM said that they will be hiring 100 sales people to sell device to doctors. This means each sales person has to get 2,270 patients to reach 227,000 patients. To hit the 2,270 patients number a salesman needs to convince only 20 doctors each performing approximately 100 surgeries per year or 1 obese surgery every 3 days. Again my numbers are so conservative. In the USA we are talking about millions of doctors and not 20 per salesman so target market is huge.
HEDGE FUNDS ARE LOADING UP AND CHOSE PENNY TO SHAKE THE TREE FOR THEM. BE WISE, LOAD UP AND MAKE THEM CHASE.
So many gross exaggerations, highly convenient omissions and possible lies!! Where to begin? We'll #$%$ the low-hanging fruit first.
1) Yes - you most certainly can go lower on your annual market share, especially if you go with the best indicator of all: actual sales performance of the product. And Maestro has been on market in numerous countries the last year and a half during which it hasn't one single blessed sale. Zero dollars in revenue.
2) Saying 69% of Americans are a likely market is ABSURD. Simply overweight people are NOT a key market for surgical intervention in obesity - much less such an expensive one out of there own pocket. To even attempt a non-insane estimate much less a responsible one, you need to slash about 60% of market size off that calculus. You or the company can WISH to target that size of market, but one must recognize the LIKELY market. Heck, why not just call it a 3-billion patient market - half the world are fatheads like you, right???
3) NO INSURANCE COVERAGE -- nice sales barrier so conveniently overlooked.....sins of omission, friend.
4) $30,000 per patient therapy - tua culpa, mendace. This isn't just a major, definitive deterrent to insurance coverage (in perpetuity or at best years down the road for only the most morbidly obese).. It is an absolute stonewall for almost every American, much less our on-average poorer fellows in the approval nations. And NOBODY who's simply overweight is going to accept $30,000 ticket and a couple of surgical interventions.
5) It is a outright falsehood (a known one, I believe in your case) to imply the FDA is favorably disposed towards any product they accept a PMA for. They will of course deny that heartily and in print. Accepting a PMA does not mean they are 'receptive' at all in the sense implied by you towards the therapy, thereby heightening the odds of its approval. That's utter (deliberate?) BS.
There's SO much #$%$ in thepost that almost totally nullifies your sales figure
These are all excellent points, but there aren't 'millions' of doctors, let alone millions who perform bariatric surgeries.
I do believe vbloc is a billion $ industry waiting to unfold. It's safety profile is substantially greater than existing gastric procedures.