No, I'm not Debbie Downer, but Robert Realistic: Very very few companies on the verge of approval put warrants in their prospectuses. NO, this is NOT boilerplate language, as, barring a buyout, the warrants will almost certainly be included in a public offering. I would place the possibility of an offering before ADCOM of over 50%.
I detest warrants as they are the weak sister of common shares. A company on the verge of a positive ADCOM does NOT have to tack on giveaway warrants. Even if ETRM does not float shares/warrants before ADCOM they have given ammunition to those hedgies and other institutions holding down the stock price.
And sell shares/warrants BEFORE the ADCOM meeting. From just filed prospectus:
" we intend to use the net proceeds from the sale of securities and exercise of warrants under this prospectus to continue work toward regulatory approval of our product in the United States, for commercialization efforts in the United States and internationally, to expand our operations and grow our research and development, product development and administrative operations and for other working capital and general corporate purposes."
pokerman: Australia FDA and European Medicines Agency has websites explaining their policies on medical devices. In general, the approval process in Australia and Europe are considerably less rigorous than the FDA's for medical devices.
one_killerbee: Thanks for your balanced post. I learned the hard way years ago to not fall in love with a stock and to continuously monitor the buy/sell/hold options. At best, VBLOC can compete in the obesity market and should be approved.; however, the ADCOM panel is NOT a rubber stamp-I expect a mixed vote.
I predict Zeeman and Adeiflig will disappear from the message board if VBLOC gets a negative vote on 6/17; excessive cheerleaders seldom stay around to face the music. I bailed on CYTK and saved a 65% haircut and flipped to ETRM. If ETRM does spike a lot pre-ADCOM, yes, I probably will sell most of my position, as I have seen too many blow ups.
Frankly, I don't think ETRM will be much higher than $2.50-3.00 going into ADCOM. If a patient wants MODERATE weight loss most diet doctors will prescribe convenient diet pills rather than having to refer a patient to a bariatric surgeon to implant VBLOC. Seriously obese patients want dramatic results and VBLOC does not give those results. Gastric bypass and lap band is still proven for huge weight loss. In the past
several women I knew had bariatric surgery and the long-term results were dramatic.
Make sure you're up early the week of June 9 to immediately read the FDA briefing documents after they are posted. The Market is going to move the most on what those docs say. Also, sometimes the Market's many semi-literate readers have a knee jerk understanding causing a temporary unjustified plunge or spike-be prepared to take advantage of that hour of semi sanity.
Ade: If VBLOC was a sure thing for in your words "easy approval", the FDA would not have called a panel, but approved VBLOC outright. The FDA is going to give A LOT OF WEIGHT to the panel votes. I'll stick with my 65% chance of FDA approval...for now.
ade: Stop with your delusions of grandeur. Retail owners of ETRM are only about 10% of total outstanding shares. The shorts are almost all big players that are masters of short covering. You and I are merely hitching a ride on the big boys' coattails.
oozhe22: I would be surprised if ETRM is at or over $3 the week of 6/9, when the FDA briefing docs are released. Approval is NOT a slam dunk. Rationally, VBLOC should be approved as it is safe and is a less invasive alternative to gastric bypass and lap band surgery. I say let the market decide its place in fighting obesity. With a recent study showing an increased risk of breast cancer in obese women, The FDA needs to approve ALL remedies that are safe, if not home runs in terms of results.
oozhe: There is a misconception that hedgies and HFT desks trade large volumes of stock, but it's just the opposite. In a given day a trader like Citadel buys and sells hundreds of stock symbols in order to make a little here and there(the "little" adds up to over $1B yearly profits for Citadel).
People need to understand that RETAIL longs only control about 10% of ETRM's trading volume and have a negligible lasting affect on the stock price. How many time have we seen 100 share trades of ETRM at say 1.84, followed by a 10,000 share block at say 1.87(most likely a retail buyer)? The market maker says thank you very much and the next 100 shares trades are back to 1.84 or even lower.
Boston startup Gelesis has picked up $12 million in venture funding, cash that'll support its novel approach to obesity treatment: a pill that disperses expanding particles in the gut to make patients feel full.
The latest funds come courtesy of the Pritzker/Vlock Family Office, founder PureTech Ventures and some undisclosed backers, the company said. The biotech plans to spend its cash on advancing Gelesis100, a capsule that releases tiny particles made up of a food-based polymer that expands in water, curbing appetites and potentially providing a weight-loss solution for patients with obesity or diabetes.
In an early clinical study, the treatment demonstrated safe and effective in helping people feel full, and now Gelesis is gearing up to release results from a placebo-controlled trial that will light the way for future development, CEO Yishai Zohar told Xconomy. Without getting into details, Zohar said his company is "very pleased" with the results, and Gelesis' $12 million raise will bankroll the next stage.
Developing and marketing treatments for obesity is a field marked by failures, whether due to dangerous side effects that alarm regulators or so-so efficacy that makes commercialization a challenge. Gelesis believes its solution has the potential to skirt those common pratfalls. By limiting stomach capacity, Gelesis100 acts like a surgical procedure, but without the need for an invasive procedure. And, unlike small-molecule drugs, its dispersed polymers are digested just like food with no need for spikes in toxicity or modulation of CNS pathways.
medsinker: I see you phony ID was created today. Alert! Your computer time at the local library is up.
adeiflig: You have your head in the sand if you think the overall market and hedge funds and HFT desks have NOTHING to do with ETRM's stock price. I'm saying don't have pie in the sky stock price projections. I do agree that the risk at today's low price represents minimal risk; however, just as a bull market lifts most boats a weak stock market in May, June and July can act as a drag on the runup in ETRM's stock price.
There's a saying "Don't Fight the Market." The overall negative market bias WILL PRESENT HEADWINDS to the optimal ETRM stock price. Just bear in mind that the Market is a lot stingier in doling out multibaggers than in the past. I am long ETRM but I respect the power of hedge funds and HFT desks, with their long/short black box trading computers to manipulate stock prices and unjustly reward some junky stocks and penalize better stocks.
Sugarman: I like your post as it spells out the roadmap. The FDA can be quite unpredictable, as is the stock market. Black box algorithms used by hedge funds(both short and long) and high frequency trading desks are so fast and sophisticated in 2014, that they tend to mitigate or slow down multibagger explosions of years past. FYI, I owned DVAX on Dec 16, 2008, when it closed at .26; the next day after a PR re a GSK alliance it closed at 1.74; the following day, 12/18 it hit 2.60, but collapsed in quick order when Merck terminated their partnership.
I will be opportunistic with ETRM and sell if there is a ridiculous price jump above the high analyst $7 target.
Stop with your homelies. I made a factual posting about the reason for the ADCOM and you pull out the negativity red herring. You sound like a Benny Hinn clone. Duh, why don't you attend the 6/17 hearing and excoriate the FDA reviewers for not walking lockstep with your grandiose opinion of VBLOC.
IF VBLOC had achieved the efficacy targets of the special protocol agreement there would have been NO ADCOM: The FDA would have possibly given VBLOC a priority review and approval would have been all but certain.
The FDA review documents will NOT be a softball critique. One has to hope that the tone is not too negative.
adeiflig: Your New Age kitchen philosophy is MEANINGLESS to Mr Market and the FDA. Good or bad, I will be on this board after 6/17-will you? Or in replying are you just going to continue your pontificating?
Your optimism should be tempered by the reality that The Overall Market right now is quite weak and not prone to allowing huge run ups in price.
PROMISE ONE THING: If ETRM's stock price fails to reach your lofty targets that you will be around for a post-mortem discussion after 6/17.