Trial isn't expected to end, ENROLLMENT is expected to end.
The trial will continue and based on results maybe, just maybe, approval five years from today.
Naturally you lied about their estimates for 4Q.
It's '55 to 60 million', not your '60 to 70M'. Nor do you provide any context such as that they have cannibalized future sales by offering a 50% discount to existing customers; the one's most likely to upgrade anyway, ie- this isn't new business.
Such an interesting list of complaints. Iluvbush was right. From now on I'll let CALL's customers answer your BS, Liars_Bold (I'm sure they would have done it themselves already if they knew about this message board).
'I bought MJ PLUS because of slick advertising on TV. "So easy, a child can hook it up" - such wild claims they had. The MJ PLUS arrived, and I proceeded to install it per their package instructions. It would only make and receive a call while hooked to the computer, but nothing as a stand-alone device. I got on their "customer support" chat and tried to resolve the problem. Many hours and people later, nothing. I finally got one to admit that there was a possibility that the jack was defective. They would replace it for a $9.95 shipping fee. I said, "Okay, send it," - three to five business days to ship. After two weeks, I got back on "chat" and was told there was a hold on the shipment. They could not tell me what the hold was.
A week and a half later, it came to my address. I attempted to install this one, but it would not even download the software to install on the computer! Two MJ PLUSes later, over a month of time gone by, several hours on "chat," and still no phone. Got back on "chat" - I believe I "chatted" with every one in the litter, plugged and replugged, checked IPs, ports, everything they could think of - no help. I asked for a refund and was told I was past my thirty-day period, so there would be none. I was cut off from "chat" several times after this. You cannot deal with these people; they are stupid to the core. I am out $95 plus twenty-some hours on "chat," and have to deal with high blood pressure. Don't buy from this company. They are blood-sucking liars and thieves.
David of Canton, NC'
The next interesting scam came in the form of a rickety internet stock called Genesis International (GENI). This scheme was hatched by Adnan Kashoggi, famed Iran-Contra arms dealer. Beginning in 2001 while all the other internet stocks were rapidly dying on the vine GENI confounded them all by rising higher and higher.
Kashoggi was openly buying GENI higher and higher (at least he correctly filed 4's so we knew). What we couldn't figure out, though, was his end game; how to profit from an otherwise worthless stock that he had personally inflated?
Let no one ever say he wasn't clever. One day he began to lend out millions of his shares to brokerages. They, in turn, lent them out to their customers. Suddenly Etrade and other brokers who previously had almost no shares to lend had them in spades (we had no idea why at the time- they just appeared). We snapped them up. It allowed me to substantially add to my position at 17.50.
Under the terms of the loan the brokerages were required to post millions in collateral with Kashoggi to guarantee the borrows which would then be marked to market. Whether his original plan had always been to simply abscond with the collateral and leave the brokerages holding the bag we'll never know. 9/11 intervened and his US checking accounts were frozen. GENI was halted at 17. He couldn't, or wouldn't, repay the brokerages and a cascade of bankruptcies ensued. By the time it reopened three months later the company was dead and the stock was trading in the 50c - 1.00 range. Etrade made me cover and I missed out on the last 75 cents.
I post this narrative because I hear you talk of 'lawfully criminal', and I laugh. The crims are in the boardrooms, and/or with you, in the boilerrooms. The shorts just expose you. That's why you detest us.
Your CALL and Borislow aren't the cleverest, or most original, or nearly scammiest of them all (see REFR), but there's no doubt that they are stock manipulators, and that they provide a suspect, substandard service judging by the volume of complaints lodged against MagicJack.
This too will crack one day. One assumes, if you do your job well, that your bosses will reassign you to another pump and dump.
I'll see you there.
Liars_Mold, long ago while you were still suckling at your mothers' teat I was ferreting out, and shorting, all kinds of scams. CALL certainly ain't the first.
Creative Hosts, CHST, happened to be an early one. A no-account, no-name company out of San Diego that leased restaurant space in airports, suddenly saw its stock rise from a buck to 30 in the course of six months in mid-2000. Since they had no earnings, and no prospect of earnings, I began shorting the stock around 10.
I continued to short it as it rose to 15, 20, 25, and 30. Naturally I and all the other shorts were wondering wtf was going on? It stank to high hell, was costing us some money, and it began to get noticed in the press.
The CEO/owner of the company, one Stuart Jackson, was also CEO/owner of another company, Bonso (BNSO), a Chinese manufacturer of scales.
Naturally I scoured the SEC filings to try to catch some clue as to what could possibly be happening with CHST. I couldn't find anything. Since I also shorted some BNSO from time to time, one day I was checking the SEC filings for BNSO. Lo and behold I discovered that Mr. Borislow, err Jackson, had *erroneously* filed a SC-13 for CHST under BNSO! It was extremely revealing. It showed that he was trying to buy up the entire float of CHST and force a short squeeze. No wonder he didn't want to tip his hand.
Naturally I immediately copied the lengthy list of open market buys onto the CHST messageboard and watched as the snit hit the fan. Within a day or two the stock began to sink like a stone. It never looked back. If you see how much he paid, and what he got when he had to sell, you will note that things did not end well for said Jackson. As he had been the only buyer going up he was now a seller with no buyers going down.
I was able to cover in the 1 - 3 range.
btw- It was the only time I ever received a subpoena from the SEC (actually a subpoena to AOL for the identity of 'yogalad') although I never heard anything after.
You ought to check out the ASTI board to see how quickly you'll get rid of me. I camped out there for three years. It'd be easier to cure genital herpes.
After years of fighting me they grew to respect me especially since everything I told them would go wrong did.
Of course fabio the board idiots never do.
Easy epix, he hasn't figured out yet that all aliases get a combined single vote.
Maybe that's why he's the true dunces_without_ money.
As do I have fun messing with you.
I wasn't expecting you to debate Sater's piece. How could you possibly? I just figured to call you on your bullsht and watch how you scamper away from your previous position.
About the Author Dr. Richard Sater-
Richard Sater is a neurologist in High Point, North Carolina. He earned his MD and PhD at Duke University and completed internship and Neurology residency at University of Pennsylvania. He also completed neuromuscular and immunology fellowships there. He is board certified in Neurology, Clinical Neurophysiology, Pain Medicine and Sleep Medicine by the American Board of Psychiatry and Neurology and MRI/CT by the American Society of Neuroimaging. Dr. Sater serves as the medical director for the NMSS recognized MS Center at High Point Neurological Associates and also serves on the board of the Central North Carolina chapter of the National Multiple Sclerosis Society and as the Chair of the their Clinical Advisory Committee. ...More Dr. Sater gives many talks each year to patient or physician groups. He also serves as medical director for MRI/CT for Cornerstone Healthcare and as medical director of the Cornerstone Sleep Center. He serves as Treasurer and is chairman of the finance committee of Cornerstone Healthcare, the largest physician owned multispecialty group in the Carolinas. He is an author of 20 scientific or medical articles and chapters and has served as site Principal Investigator for multiple clinical studies.
Silenor appears to be an effective agent for the treatment of pure maintenance insomnia that is safe and very well tolerated. These positive attributes are balanced by its inability to prove efficacy for sleep onset insomnia and the lack of data to distinguish itself from the off-label 10 mg dose of doxepin. All things being equal, doctors would prefer to prescribe an on-label non-scheduled product. However, insurance companies and prescription benefit managers have a nasty habit of taking cost into account. Paperwork is less when generics are prescribed. Hence, I seldom need to fill out additional forms for generic Ambien (zolpidem) or for the off label use of doxepin, trazodone, mirtazapine, gabapentin or other generic compounds. Indeed, many plans require that a patient fail zolpidem before being covered for one of the branded products that is FDA approved for insomnia. Additionally, many patients specifically ask for a generic compound over a branded one. The patients who may best benefit from low dose doxepin, the elderly, are also the patients most likely to request a generic compound and to be unable to afford their medication. Though Somaxon may offer coupons and vouchers that can help defray Tier 3 co-pays for privately insured patients, Medicare does not allow the use of these. In my experience, patients do not care whether a product is on-label or off-label as long as it is effective, and for most patients, affordable.
For all these reasons, I believe that Silenor will have difficulty achieving impressive sales. Marketing, manufacturing and regulatory expenses will take a big chunk out of sales. This has likely been realized by other pharmaceutical companies as no partner has come forward despite nearly 3 months passing since the FDA approval. Somaxon appears to still be counting on a partnership as they have not yet developed or rented their own sales force. Somaxon may be forced to take a less lucrative contract to cement a partnership. With no other compound in the pipeline, they must act soon as the clock is ticking with a potential patent challenge in 2013. If one is interested in taking a long position, a better entry may be at 4 dollars as this was the price before FDA approval and is just above the 200 day moving average. When it comes to investing in Somaxon, I will avoid taking a position and avoid the sleepless nights.
With over 25 million Americans suffering from chronic insomnia and more suffering from transient insomnia, the potential market is very large. Even if just the 8 to 9 million patients with pure sleep maintenance chronic insomnia are counted, sales could be huge. If one assumes a wholesale price of about $120/month and 10% penetrance, annual sales could break 1 billion. The side effect profile is excellent and patients taking Silenor are probably less likely to experience rare parasomnias such as sleepwalking or other sleep related activity that have been seen with Ambien and Lunesta. Additionally, unlike Ambien and Lunesta, Silenor will not be a scheduled substance with the DEA. This allows for more widespread product sampling. Most doctors prefer to write for non-scheduled drugs and Silenor prescriptions could be written for 12 months instead of only 6 months for Ambien or Lunesta.
Doxepin is not a novel compound, though the 3 and 6 mg. Silenor products forr the insomnia indication will have patent protection for a while. The sleep market is dominated by generic and branded products and the off-label use of many drugs, including doxepin, is common. Generic doxepin 10 mg capsules are only 10 to 15 cents a pill. Liquid doxepin can easily be dosed at 6 mg with a dropper at pennies a day. Because the 10 mg dose has not been tested for insomnia, Silenor 6 mg can not claim superiority in either efficacy or tolerability against doxepin 10 mg. Indeed, their own data suggests that 6 mg might not be the optimal dose as 6 mg performed better than 3 mg which performed better than 1 mg. Could a higher dose have worked better? Obviously, Somaxon was not motivated to test the 10 mg dose as a new branded product since a generic already existed.
Even the lower doses have weak patent protection for the chronic insomnia indication. The in-licensed patent for the treatment of chronic insomnia, covering doses from 0.5 mg to 20 mg of Doxepin, will expire in 2013 (from the form 10-K for 2009). The in-licensed patent for the less commonly treated transient insomnia does not expire until 2020. Furthermore, they do not have patent protection outside the US.
Studies did not convincingly support a longer term benefit for Silenor in reducing the latency to persistent sleep. Therefore, the FDA only approved Silenor with the indication for the treatment of insomnia characterized by difficulties with sleep maintenance. Many insomnia patients have either sleep onset insomnia alone or both onset and maintenance insomnia. These patients would likely benefit more from other products. Sales representatives will not be able to market the drug for sleep onset, mixed or combined chronic insomnia. Doing so would risk penalties for off-label promotion. Also, because 6 mg was not tested against 10 mg or higher doses, Silenor reps will not be able to easily counter questions asking if the 6 mg dose is better (either in efficacy or tolerability) than the other off-label doses.
From Seeking Alpha-
Sleepless Nights for Somaxon 9-Jun-10 12:27 pm
Sleepless Nights for Somaxon: Will It Find a Partner for Its Insomnia Drug?
by: Richard Sater June 08, 2010
On March 18, 2010, Somaxon Pharmaxeuticals (SOMX) was granted FDA approval to sell Silenor 3 and 6 mg. tablets for the treatment of insomnia characterized by difficulty with sleep maintenance. This approval was met with a stock price move from 4 to 10 dollars. Shares were only 30 cents just one year earlier. The stock has lost half its value since the day after FDA approval to just above 5 dollars. Can the stock rebound or will the price continue to drop?
Silenor is a unique dose of the compound doxepin (Sinequan) which is available as a generic in 10, 25, 50, 75, 100 and 150 mg capsules and a 10 mg/ml concentrate liquid. Silenor’s mechanism of action is likely due to histamine blocking. This is a different mechanism from Ambien (Sanofi-Aventis (SNY)), Lunesta (Sepracor (SEPR)) and Sonata (King Pharmaceuticals (KG)) which work through the GABAalpha1 receptor or from Rozerem (Takeda Pharmaceuticals (TKPHF.PK)) that works through the melatonin receptor.
Frequency and subtypes of insomnia
Based on polls and surveys, insomnia affects about 35% of American adults. Chronic insomnia, manifested by insomnia more than 3 days a week, is estimated to affect about 10% of the population and is linked to poorer quality of life and mood disorders. Chronic insomnia can be subtyped into four groups. Sleep onset insomnia involves 3 or more nights a week where the sleep onset latency or the similar latency to persistent sleep (SOL or LPS) is over 30 minutes and sleep is fine during the rest of the night. Sleep maintenance insomnia can be defined as more than 30 minutes of wakefulness after sleep onset (WASO) is achieved for 3 or more nights a week. Combined insomnia involves both delayed SOL and increased WASO the same night more than 3 nights a week. Mixed insomnia is either delayed SOL or increased WASO for 3 nights a week. Studies requiring subjects to fill out a sleep diary every morning are likely more accurate than the more common larger phone surveys. One such sleep diary study found the percent of chronic insomnia patients with sleep onset, sleep maintenance, mixed and combined insomnia was 23%, 34%, 16% and 26%. In general, the elderly are more likely to have maintenance or combined insomnia while younger adults are more likely to have onset or combined insomnia.
Studies with Silenor
Silenor was tested in several Phase II and 3 phase III studies in adults and the elderly with chronic insomnia and in one other phase III study in adults in a phase advanced model of transient insomnia (summarized in the form 10-K, for 2008). Briefly summarizing the studies, significance in wakefulness after sleep onset and total sleep time (TST) was found in a dose dependent manner. However, improved latency to persistent sleep was generally only found for the higher dose on night one and not 5 to 8 weeks later. Because Silenor did not convincingly show efficacy for sleep onset, the drug is only approved for sleep maintenance. Ambien and Rozerem are FDA approved for sleep onset insomnia and Ambien CR and Lunesta are FDA approved for both sleep onset and sleep maintenance insomnia. Ambien (zolpidem) is only approved for short term use while Ambien CR, Lunesta and Rozerem are approved for any duration of use.
The drug was generally well tolerated with no significant increased adverse effect compared to placebo. This differs from the anticholinergic side effects commonly seen with the doses of doxepin used to treat depression (75 mg or higher) such as dry mouth, dry eyes, or persistent somnolence.
Doxepin comes in 10 mg capsules, not 5's or 20's.
Clearly not the drug I was talking about.
You've proven your stupidity beyond a reasonable doubt. You made your case. We get it. You don't need to reargue it for us. We're convinced.
So relax and go color some pictures.
Help is on the way.
Only 261 cents away.
Just imagine that blessed day when ASTI finally reaches zero and you can at last say goodbye to this long frightful episode. For some; Winnie, blue, Hemingfay, and others who have already lost as much as four years of their lives this sad but joyful event cannot arrive soon enough!
The only advice I have is to try to forget the stolen time, the wasted money and try to focus on your remaining years. There is still time for some of you to live full, productive lives. My greatest fear is that it is probably already too late to deinstitutionalize the ultra long timers :(
Just remember that no matter how extreme your adversity may seem at the moment courage and conviction has helped others surmount even greater challenges in their lives.
Hard to believe but true!
Best of luck,
The longs do not believe in reading anything that might throw caution on their ravings of riches but other investors do.
This is why you can't take Doxepin and turn it into a silk purse. There's no patent protection and no one's going to invest hundreds of millions of dollars promoting a drug that goes for PENNIES A DOSE!!
..."Although we have an exclusive, worldwide license for Silenor for the treatment of insomnia we do not have patent protection for Silenor in any jurisdiction outside the United States "...
... "Our in-licensed patent for the treatment of chronic insomnia is scheduled to expire in March 2013 "...
... "A competitor could attempt to market doxepin for a chronic insomnia indication as early as March 2013 "...
... "Doxepin is available in generic form in strengths as low as 10 mg in capsule form, as well as in a concentrated liquid form dispensed by a marked dropper and calibrated for 5 mg. As a result, we may face competition from the off-label use of these or other dosage forms of generic doxepin. Off-label use occurs when a drug that is approved by the FDA for one indication is prescribed by physicians for a different, unapproved indication "...
..." Others may attempt to commercialize low-dose doxepin in the European Union, Canada, Mexico or other markets where we do not have patent protection for Silenor "...
..." Due to the lack of patent protection for doxepin in territories outside the United States and the potential for correspondingly lower prices for the drug in those markets, it is possible that patients will seek to acquire low-dose doxepin in those other territories "...
..." The off-label use of generic doxepin in the United States or the importation of doxepin from foreign markets could adversely affect the commercial potential for Silenor and adversely affect our overall business and financial results. "...
(read it right here at http://www.insidercow.com/)
The Insiders have given you 1,800,000 reasons why SOMX is GROSSLY OVERVALUED !!!
They sold their shares at an average of 6.42.
I can assure you that it wasn't because they thought SOMX was going to 10.50 !!
Maybe you longs think you know better than the execs who run the company but I'm taking their side of this bet !
3/18/2010 …. TURNER DANIEL …. 10% owner …. -1500000 …. 6.38 ……… $9,573,600
3/18/2010 …. Dorsey Brian …. VP Product Development …. -500 …. 9.73 ……… $4,868
3/18/2010 …. Dorsey Brian …. VP Product Development …. -2800 …. 8.78 ……… $24,596
3/18/2010 …. Dorsey Brian …. VP Product Development …. -15900 …. 7.92 ……… $125,947
3/18/2010 …. Dorsey Brian …. VP Product Development …. -15800 …. 6.67 ……… $105,323
3/18/2010 …. Dorsey Brian …. VP Product Development …. -23000 …. 5.23 ……… $120,262
3/18/2010 …. Dorsey Brian …. VP Product Development …. -500 …. 9.75 ……… $4,874
3/18/2010 …. Dorsey Brian …. VP Product Development …. -1800 …. 8.91 ……… $16,038
3/18/2010 …. Dorsey Brian …. VP Product Development …. -2100 …. 7.89 ……… $16,572
3/18/2010 …. Dorsey Brian …. VP Product Development …. -8100 …. 6.61 ……… $53,569
3/18/2010 …. Onaitis Matthew …. VP, General Counsel …. -14454 …. 9 ……… $130,086
3/18/2010 …. Onaitis Matthew …. VP, General Counsel …. -15000 …. 6.59 ……… $98,882
3/18/2010 …. Onaitis Matthew …. VP, General Counsel …. -2627 …. 7 ……… $18,389
3/18/2010 …. Pascoe Richard …. President and CEO …. -1200 …. 9.58 ……… $11,491
3/18/2010 …. Pascoe Richard …. President and CEO …. -2600 …. 8.74 ……… $22,719
3/18/2010 …. Pascoe Richard …. President and CEO …. -4800 …. 7.53 ……… $36,156
3/18/2010 …. Pascoe Richard …. President and CEO …. -15100 …. 6.42 ……… $96,928
3/18/2010 …. Pascoe Richard …. President and CEO …. -76300 …. 5.62 ……… $429,111
3/18/2010 …. Pascoe Richard …. President and CEO …. -4510 …. 6.5 ……… $29,311
3/18/2010 …. Raser Jeffrey …. VP, Sales and Marketing …. -1200 …. 9.73 ……… $11,682
3/18/2010 …. Raser Jeffrey …. VP, Sales and Marketing …. -6800 …. 8.82 ……… $60,004
3/18/2010 …. Raser Jeffrey …. VP, Sales and Marketing …. -7500 …. 7.84 ……… $58,822
3/18/2010 …. Raser Jeffrey …. VP, Sales and Marketing …. -24500 …. 6.57 ……… $161,053
3/18/2010 …. Raser Jeffrey …. VP, Sales and Marketing …. -230 …. 9.75 ……… $2,243
3/18/2010 …. Raser Jeffrey …. VP, Sales and Marketing …. -2100 …. 8.84 ……… $18,571
3/18/2010 …. Raser Jeffrey …. VP, Sales and Marketing …. -2400 …. 7.81 ……… $18,753
3/18/2010 …. Raser Jeffrey …. VP, Sales and Marketing …. -7770 …. 6.56 ……… $50,956
-1,759,591 ….. 6.42 ……… $11,300,807
The only 'fundamentals' here are funny mentals.
Stocksgoup is right, Somaxon has already accomplished everything they need to and something very few small companies will ever do; they raised $50M and now they're rich.
They'll make some show of trying to build a business out of Silenor but that will only be to protect themselves from any possibility of shareholder legal action. They won't waste any money beyond the requisite window-dressing.