The $3.00 "buy" ratings had NO impact -- stock is off 15% since Lake Street#$%$ (aka Fake Street, btw) and Canaccord's came after picking up a 20-million-share shelf registration they only make money on if they get other people to but them!!!!!
And a company usually needs TWO large, well-designed SUCCESSFUL trials to get FDA approval. But Maestro dramatically failed ALL - that's right ALL - the FDA's success-defining endpoints, both primary AND secondary in EACH trial. That's ALL of FIVE FDA-specified definitions of success.
The stock tanked 70% - yes, a full 70% - after the second trial failed so abysmally.
I can not find a single therapy that ever got FDA approval off of BOTH its major trials failing FDA standards OUTRIGHT. NONE ---- EVER.
Beware these bunco artists trying to hype this stock!!!!! Unless you're one of them????
Both Canaccord and Lake Street raised their target prices to $ 3 per share.
This is the reason:
a) Either 4th Quarter 2013 or early 1st Quarter 2014 FDA Panel to consider VBLOC
B) A few months later since it is a PMA for a device FDA approval.
A little of VBLOC it is a device which will be implanted in a person to help lose weight. The first users will be those who are obese. The pills from VVUS, OREX, ARNA, do not help these people since it is a short term solution and has serious side effects. VBLOC has been show to be safe, people lost 24% of their weight and, it also beneficial for hyptension and diebetic.
Statistics show U.S. spends $ 147 billion per year medically on people who are not fit and which obesity leads to an assortement of other problems.
The target market for VBLOC is huge since 69% of the US is either overweight to obese. If VBLOC obtain only .001 of the market it represents 277,000 people. The device will retail at $ 5,000 and will bring in $ 1 billion per year.
There was an issue from clinical results since those on placebo (fake device) lost 15% of their weight. We all know that sitting on a chair with a fake device does not result in lost weight so it was mental power in believing device worked. ETRM has explained this to the FDA prior to the filing and, FDA encouraged them to file preferring to go with the FDA Panel when results have not attained primary end points due to fluke (placebo) which will be explained.
My target price is $ 3 to $ 4 prior to FDA panel, $ 6 to $ 7 on FDA approval and, $ 10 and over with FDA stamp.
ETRM plans to hire 100 salespeople to sell VBLOC. The device is approved in Austrialia however ETRM has preferred to put this market on hold since criticial market for obesity is really U.S. In Austrialia there is not an obesity problem.
Great summary! I would like to add that the device has also been approved in the EU (EMA approval is not needed in EU for a device - the device received an EU mark approval allowing the device to be sold). Although there is a obese market in EU and Australia, the company is currently focusing the financial resources on gaining US FDA approval. Once FDA approval is attained, the company plans to devote resources to building a sales team to market the device all at once to all approved markets (US, EU, Australia). US FDA approval obviously gives the device additional marketing power in EU and Australia even though not necessary in those markets - it just provides a further "stamp of approval."
Pembroke: You don't ask an anonymous board, you read the press releases and SEC filings for the past few years to get a feel for the company. That said, the upcoming quarterly webcast should shed light on the application status with the FDA and when an advisory meeting can be expected.