Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
R U kidding? They've been spinning for years; "best shape ever", "many irons in the fire," "high morale", "multiple shots on goal," "partnership soon," blah, blah, blah. The problem is: Very few investors are buying it, and I can't recall anybody in the industry ever buying it, at least since the artifact revealed itself.
Meix-about your theory that some sign is being kept secret: Maybe it is another MOA for erections. That would give new meaning to staying awake...SA and insomnia: rising for the occasion...or perhaps, a future rise in Cortex induced optimism. It also gives two new meanings to "carrot on a stick?" :)
Ps. I decided to take off work today...well before the Corx news (and taking off work, other than vacations, I do maybe once a year). An uncanny coincidence wouldn't you say?
In those situations, people tend to be more affable. With that said, when people snap, there is usually very little warning :)
Cortex must have been so excited about the news, that they forgot to plan/include a conference call in the PR, to further enlighten shareholders about our bright future...
There will likely be a better life for Ampakines if Corx ceases to exist (or current mgmt concedes). The molecules don't go the way of shareholders and mgmnt should the company fail or put themselves up for sale--this is what I mean by a little hope may be more dangerous/risky (as an investor). It is essential to look at the bigger picture when evaluating the prospects of Ampakines.
Given this specific marker, I agree:
You're on fire! I love it...and couldn't agree more. I would only add that they get something going on the AD front--even if the pay-off is way down the road.
At least now, this sloppy, single-tasking mgmnt team can expedite the ADHD IND. Or can't they? Who knows really.
I would be willing to load up quite a bit more--if only we improved the quality of our mngmnt. Like Jerry said--we know Ampakines show an effect on the central nervous system (and brain stem) without cardiovascular compromise. The science is still rich with potential, but the execution and strategy is oh so poor...
Wow CHM-How did you retrieve the release? I still don't see anything on Yahoo Finance or Corx home page.
Well, what do you guys think? The results seem to be all over the place--hard to interpret what value the market will place on the info. I can't imagine how Corx mngmnt will be able to sell this mixed bag going forward. One concretely good thing: The safety profile did not include any surprises.
Depomed's Stock Price Is a Gift Following FDA Approval of Pain Drug
http://seekingalpha.com/article/249511-depomed-s-stock-price-is-a-gift-following-fda-approval-of-pain-drug?source=yahoo
Now that Depomed's (DEPO) GRALISE has been approved by the FDA, making a bull case for Depomed becomes easy. GRALISE is an extended release gabapentin formulation, formerly DM-1796, that is prescribed once-daily for the treatment of post-herpetic-neuralgia ("PHN"), which is pain associated with shingles. Approval of GRALISE triggers a milestone payment of $48 million from Abbott (ABT) to Depomed, or approximately $1 per share.
Dosing and Adverse Events make GRALISE compelling
The most compelling feature of GRALISE is the tame adverse events profile. The incidence of dizziness for patients treated with GRALISE was 10.9% versus 2.2% for placebo. The incidence of somnolence was 4.5% versus 2.7% for placebo. The incidence of headache was 4.2% versus 4.1% for placebo. The difference becomes tremendous when you juxtapose GRALISE's profile against that of LYRICA, Pfizer's (PFE) blockbuster drug with annual sales over $2 billion dollars worldwide. Besides dizziness, somnolence, and headache, LYRICA also mentions peripheral edema, weight gain and angioedema as common adverse events, unlike GRALISE. For LYRICA, the incidence of dizziness was 31% versus 9% for placebo. The incidence of somnolence was 18% versus 5% for placebo. The incidence of headache was 8% versus 4% for placebo.
Dizziness (treatment group) Dizziness (placebo group)
GRALISE 10.9% 2.2%
LYRICA 31% 9%
Somnolence (treatment group) Somnolence (placebo group)
GRALISE 4.5% 2.7%
LYRICA 18% 5%
Headache (active group) Headache (placebo group)
GRALISE 4.2% 4.1%
LYRICA 8% 4%
The dropouts rate during the clinical trials, again, demonstrates GRALISE's superior tolerability. The drop-out rate due to adverse events for GRALISE was 9.7% versus 14% for LYRICA.
Drop-out rate due to Adverse Events
GRALISE 9.7%
LYRICA 14%
Furthermore, GRALISE is dosed once-daily versus LYRICA which is dosed two-to-three times daily. Although a head-to-head study for this type of comparison would be preferred, this data is highly suggestive of GRALISE's superiority over LYRICA with regards to dosing, tolerability, and adverse events. Whether GRALISE will achieve superior sales remains to be seen.
The comparison of GRALISE to generic gabapentin (NEURONTIN) is just as impressive.
Dizziness (active group) Dizziness (placebo group)
GRALISE 4.2% 4.1%
NEURONTIN 28.8% 7.5%
Somnolence (active group) Somnolence (placebo group)
GRALISE 4.2% 4.1%
NEURONTIN 21.8% 5.3%
Headache (active group) Headache (placebo group)
GRALISE 4.2% 4.1%
NEURONTIN 3.3% 3.1%
Marketing against generics and LYRICA
One of the main issues for GRALISE's launch will be how to position the product against LYRICA and generic products. Generic LYRICA may hit the market in Q1 of 2014, while generic gabapentin is already on the market and commands a majority percentage of the total scripts for this class of drug. It is clear that detailing and labeling will play a paramount role for GRALISE. Since GRALISE appears medically superior to both LYRICA and generic gabapentin, the main issue won't be a lack of prescriptions made by physicians. More probably, the issue may involve pharmacies, generic substitution, and reimbursement from managed care.
Depomed can combat generic substitution in a number of ways. First of all, given GRALISE's significantly different dosing and pharmokinetics, the FDA was willing to work with DEPO to make sure less substitution occurs. For example, Depomed was able to ensure that the phrase "GRALISE is not interchangeable with other Gabapentin products" appears on the front of every label and bottle. Furthermore, Depomed is employing a 30-day "titration pack", similar to Pfizer's popular Z-Pak, making generic substitution somewhat more cumbersome at the pharmacy. When a physicians prescribes the "titration pack", it will be difficult for a pharmacy to switch to a generic.
Finally, GRALISE is not a controlled substance, whereas LYRICA is controlled. A controlled substance means that pharmacies have to adhere to strict rules regarding sales and distribution. For example, it is difficult for a practitioner to orally prescribe LYRICA to a pharmacy, since a written follow-up must be submitted to the pharmacy within 72 hours. Furthermore, pharmacies must keep logs and records of all controlled substance prescriptions, like those of LYRICA, for five years. These and other regulations are reasons why pharmacies tend not to stock controlled substances. But GRALISE is not a controlled substance, it will not have these issues, and will probably be preferred at the pharmacy.
GRALISE has selling points for managed care too! Slips and falls are a precursor to death in the elderly. The decrease in somnolence and dizziness seen with GRALISE could potentially save lives, but also hospital costs for managed care. In 2000, the total direct cost of all fall injuries for people 65 and older exceeded $19 billion, and is expected to reach $55 billion in 2020.
In one of Xenoport's (XNPT) clinical trials for HORIZANT (gabapentin enacarbil), one subject died after a fall, 25 days after stopping HORIZANT. The fall was deemed unrelated to HORIZANT, but the point here is that falls can be deadly for the elderly, and expensive for managed care. From this perspective, managed care may prefer GRALISE over its competitors.
Ongoing Mediation with Abbott, risk revaluation for Serada and more deals to come...
One week ago, when Depomed announced that they would enter mediation with Abbott, FDA approval was still an uncertainty. Now it's not. And everyday that Abbott delays GRALISE's launch, is another day of damages that Abbott will be forced to pay if the dispute enters arbitration. With this in mind, one can assume a speedy resolution. And with that resolution, one can expect that Abbott will pay some penalty for breaking their contract which in its current form has substantial sales milestones.
Approval not only gives Depomed more leverage when dealing with Abbott, it also revaluates the pipeline. SERADA, like GRALISE, is also a gabapentin formulation. With this recent approval, certain risks that haunted SERADA can be readjusted in Depomed's favor. Furthermore the Acuform technology is again reaffirmed. With another approval, Depomed may have more strength in any negotiations to license DM-1992 for Parkinson's, DM-3458 for GERD, ProQuin for Urinary Tract Infections, or its patents for Glumetza.
Final Thoughts
A revaluation of Depomed stock price is in order. But beyond the initial, expected bump in PPS, investors can look forward to a number of key events for continued stock price appreciation. Abbott and Depomed's resolution over GRALISE is clearly paramount. Later, Depomed will partner GRALISE both in the U.S. and the rest of world, which should bring in more cash and more favorable royalties. But also, investors can expect a revaluation of Serada, the technology as a whole, and the rest of Depomed's pipeline. Depomed's story will unfold throughout 2011, with many significant events that investors can look forward to.
I would like to see a series of good scientific announcements. I could see this happening. But then it gets unpredictable. I would like to see some share appreciation which garners some serious offers ie., venture cap, pharma, sugar daddy (Brin or Zuckerberg) or sugar momma (Oprah), etc. If that happened, I would expect mngmnt to get squeezed-out fairly quickly. If they don't, I would begin to question whether or not I've misjudged them. The latter I don't expect to see. If it did come to pass, I would be willing to admit my own mis-characterizations, to the extent they were off. Some of my calls, however, would likely never be reversed. Being as fair as I am, though, I won't rule out 'never' completely 100%. Finally, I expect whimsical and superficial pumpers to precede any announcement or assumed announcement for as long as our quasi and pseudo-capitalistic economy and corrupted society exists. Speaking of announcement, Corx is on the cusp of an imminent one, aren't they, lol? "To the moon," they would say.
I could also see meagerly modest good results, modestly bad results, and nearly worthless results. It's all on the table. It's virtually impossible to have phenomenal results, as the delay in reporting has irreversibly dulled even the most colorful of data. It is possible that I'm wrong, but not likely. More likely, the 'experts' will be more wrong than me, including but not limited to the so-called leaders of the company, even though I genuinely wish they were more accurate in their stated confidence, missions, and goals.
The most I see is modest upside under this mngmnt, but there is a reasonable chance that shareholders bail out or get sold out at these levels, or lose completely. I'm keeping my confidence at realistic levels, 50% upside appreciation, 50% current equity or less in total return. I am referring to the chances of it going up, not the return on investment if it does.
There is a possibility, under this mgmnt, that we spike over $1 pps at some point. That would be a good opportunity to lock in some return of principal, but make sure the GTC limit order is already there.
If mngmnt bails out at the right time, which is highly unlikely, we may see .55-.60c pps on a sell, not much different then the MEMY takeover by Roche (?). This is my highest expectation, but one I consider to be modest in return.
I hope I covered all the angles. Let me know if there were any gaps.
Ps. Total loss of capital is also in the cards, but that is unlikely in the near term, because the carrots just keep on coming, and the stick is still active. Not that it is well maintained, but usable--even given the unstable hand holding it.
...prime the pump, start your engines...
Is this your sick metaphor exploiting the recent anniversary of the Challenger disaster?
Are we in a time warp...
First installment of the Sunday Funnies...
OT-Will the real culprit of booze, broads, and gambling, please rise (this guy makes Corx mgmnt look like angels):
Anti-aging inventor accused of defrauding investors in Miami Beach
Selling anti-aging formulas
By David Ovalle, Miami Herald
8:44 a.m. EST, January 30, 2011
Joseph Fox Batista calls himself a relative of the Batista clan that used to run Cuba, a self-taught inventor and microbiologist who claims to have discovered the fountain of youth through a natural enzyme and yogurt bacteria.
Some other people call him a crook.
At least they do now. Investigators say Fox, 55, duped dozens of dazzled investors into buying $380,000 worth of stock in his Miami Beach company, Telogenesis Inc., which they say he promptly spent on fancy apartments, booze and lavish dinners.
His yogurt cream purports to grow hair on balding men, turn hair dark from gray and generally reverse the aging process.
Fox is jailed at the county's MetroWest Detention Center awaiting trial on charges of grand theft and organized scheme to defraud.
In a rambling jailhouse interview, Fox insisted his ``telomerase'' yogurt product is on the verge of a breakthrough, but he is being persecuted by shady forces, possibly members of the powerful and very jealous hair transplant industry.
Fox insisted he never misspent investors' money.
``Obviously, I have to be paid. I'm the CEO of a corporation. The CEO gets at least $100,000 a year,'' Fox said last week. ``I'm actually paying myself very little -- at times, nothing. I have running costs. I have to pay my rent. I have to feed myself. I'm doing the work of 1,000 people.''
Even supporters who still believe in his science agree that Fox misused investor money.
`A GENIUS, BUT'
``He's a genius, but he can't conduct business. He scams everyone with his stocks,'' said Miami Beach customer Peter Graves, 69, who thinks the product has delivered a few new hairs but not the ``Astro-turf'' he'd hoped for. ``Some of it is paranoia. He doesn't want anyone to steal it.''
Four years ago, Fox appeared in South Beach, a slender man with green eyes, bowl haircut and a penchant for white Panama hats, guayabera shirts and sparkly dress shoes.
``He had so much faith in himself. I don't even think he knows he's crazy,'' said former roommate David Dobrin, 20. ``He truly thinks he's the smartest person in the world.''
Homeless at first, Fox began pitching his ideas -- and spinning his life story -- to pedestrians on Lincoln Road in 2007.
Within a few years, flush with investor cash, he was living at the posh Flamingo condo in South Beach.
Born Luis Miguel Hernandez Batista, Fox claims he is the nephew of former Cuban dictator Fulgencio Batista, a story investors say he peddled to prove he is politically connected.
His family changed his name as a youth in Los Angeles to ``protect me from the Castro regime,'' Fox said.
However, Batista's grandson says Fox isn't a relative. ``I know a lot of uncles and aunts and cousins, and I've never heard of him,'' said Miami lawyer Raoul Cantero, a former Florida Supreme Court justice.
Fox's career as a con man began in California, police say. In 2002, he was convicted of grand theft and spent 272 days in jail.
The scheme he peddled, via the Web: the ``Fox Gold Detector,'' a machine that purported to weigh the amount of gold in any object. Nine clients spent a total of more than $20,000 to buy the machines, which Fox never delivered, according to Manhattan Beach police.
Fox insists the machines were real. But he said he couldn't deliver the devices, which he said could be used to expose fake gold bars at Fort Knox, because they were seized ``by the secret police, or whoever controls the currency.''
After his jail stint, Fox says he began experimenting with the ``Fountain of Youth'' yogurt.
At the heart of his so-called invention is a naturally occuring enzyme known as telomerase, discovered in the early '80s, which scientists believe stems the decline of cells. But the research is still basic, and has not shown that successfully introducing the enzyme into the body can reverse aging in older humans, experts say.
Fox asserts he can get the enzyme into the body through yogurt bacteria. That's a dubious claim, said Michigan clinical physician Dr. Michael Fossel.
``Total waste of time,'' said Fossel, a Michigan State University professor and author of the 2004 book Cells, Aging, and Human Disease. ``On the face of it, scientifically, it's got to be'' bogus.
PITCHMAN
But Fox pitched it well, throwing around scientific terms with authority and accuracy, said Dr. Andrew Pastewski, a pulmonologist at Jackson South Community Hospital who in 2007 invested $2,000 in Telogenesis.
Pastewski knew the idea was a long shot. He never got a return on his money, but did received monthly e-mails from Fox histrionically touting riches to come, and showing photos of new little hairs growing on a bald man.
``You CAN make your OWN little production for a YOGURT PARTY, say, for your friends and family as you desire, with this wonderful FOUNTAIN OF YOUTH YOGURT!'' Fox proclaimed in one e-mail.
Pastewski joked: ``I've spent more money on golf . . . I got my money's worth in entertainment alone with this guy.''
Other investors were not laughing. John Efta, 47, of Kenai, Alaska, lost $28,000 in the company. Efta thought the investment would yield good returns, and also hoped the science would help cure his diabetes.
``I want him hung on the wall,'' Efta said of Fox. ``He had a hell of a good time at my expense.''
Efta complained to Florida's Office of Financial Regulation, which dispatched Patricia Perez to investigate Fox's business. She declined comment.
Fox insisted the investment money went to lab testing, clinical trials, production and marketing. But Perez found that virtually none of the money invested between July 2007 and November 2009 went to building the company, according to an arrest warrant.
Combing through bank records and interviewing victims, Perez found that most of the money went to Fox's daily living expenses, the warrant said. One investor, Peter Walton -- who even moved to South Beach from Oregon in a failed attempt to support the business -- told Perez that Fox frequently withdrew investor money for ``alcohol or drugs.''
BIG EXPENSES
Walton's son, John Walton, and his friend Dobrin lived with Fox for six months and said Fox developed a drug problem. They said he blew thousands weekly on expensive dinners for friends.
Once, Fox bragged about handing out wads of cash to patrons at the Lost Weekend bar in South Beach.
``It was common for him to hand out $100 bills to homeless people,'' Dobrin said. ``He literally just gives his money out to look like a big shot.''
From jail, Fox swore he didn't live an extravagant lifestyle on investors' dimes. Instead, he blames the Waltons, Efta and Perez for conspiring against him.
``Patricia Perez apparently doesn't believe in telomerase, or the Fountain of Youth,'' Fox said. ``She's trying to steal my invention from me, essentially.''
News Flash: CNN Documentary on Alzheimer’s Disease
28 January 2011. For all readers who are looking forward to watch Filling the Blank, Felipe Barral’s CNN documentary on Alzheimer’s disease starting Saturday, January 29, here is new information Alzforum learned today. The film is a production of the Special Projects Unit at CNN International and CNN en Espanol. Even though most people might think of CNN as one entity, in practice it’s not. In this case, this has meant that while CNN International and CNN en Espanol are broadcasting the documentary film at the show times we posted last week (see ARF related news story), it looks as if CNN/US will not air the film along with its sister channels in this first worldwide release. We will keep you posted if we hear otherwise.
Depending on where you live, this may not affect you. But for those who can only access CNN/U.S., here’s a consolation. The full documentary will be available for streaming at CNN.com starting early next week. Meanwhile, the company has loaded a story and some video clips to its world’s untold stories website.—Gabrielle Strobel.
Sorry, I don't get the reference. Politics and the corresponding rhetoric have been too disturbing to follow lately (plus, family and work occupy most of my time). I hear her name being thrown around, but I have no idea why. I don't even have a strong desire to find out what insult you are trying to convey. I see about 12 managers of one kind or another every day--common business sense is just that: common sense. The Corx leaders have proven time after time how lame they are--the history speaks for itself. Your own misjudgments on this company are similarly evident and repetitive--the parallel is no surprise.
Agreed: Impressive credentials indeed. I believe he may have taken one job too many, or leapt one step too high. Just to be fair though, it ain't over yet. Sometimes people are kept on because they just aren't bad enough. That's what they call complacency.
It's a branding label, much like Corx.ob. I only wish it would have rehabilitated the offenders. Goes to show--can't teach an old pig new tricks.
From the 2007 Roth Conference (under Near Term Milestones):
I sense a minuscule amount of skepticism in your post (lol). Maybe you would reevaluate your stance after considering the 'packages' Corx has at their disposal (pun intended), courtesy of Servier and Merck. Also consider [how little] downside there is left after the many failures (mostly strategic and implementation failures) . You never know, maybe they will even announce that the AD pet trial has been completed and results are favorable...
Mark Your Calendars: Powerful CNN Documentary on Alzheimer’s
21 January 2011. Invite your friends over, gather loved ones, serve some good munchies, and settle in for a night of TV well worth watching. Starting next Saturday, 29 January 2011, CNN will air a documentary film by Felipe Barral. It will focus the attention of viewers around the globe on the terrible scourge that is familial Alzheimer’s disease. But more than that, it also showcases a wave of international momentum that is building among inspiring families, committed doctors, scientists—and hopefully industry and regulators—to stop the disease with prevention and therapeutic trials.
Barral, an artist and senior producer at the CNNI/E Special projects unit, last August and September traveled to Colombia and across the U.S. to document the plight of families with autosomal-dominant AD. He also features the work of the Alzheimer’s Prevention Initiative driven by Eric Reiman, Pierre Tariot, Jessica Langbaum, at the Banner Alzheimer’s Center in Phoenix, Arizona, and Kenneth Kosik at the University of California, Santa Barbara. The film features extensive footage of members of the Colombian families carrying the presenilin-1 Paisa mutation and of Francisco Lopera, the neurologist who has cared for them for decades and has built a research team and a robust body of data to support prevention trials now.
Among others, Barral also filmed members of the Noonan family, who have done much to publicize the need for more research. In doing so, he caught the last contribution to this awareness-raising effort by Butch Noonan, the family's most recent loved one to pass away (see also ARF London story). Some of the Noonans participate in the Dominantly Inherited Alzheimer Network (DIAN), also an ongoing international effort to test drug candidates in autosomal-dominant families. Butch passed away on 4 November 2010. You can appreciate his last gift to the family’s cause when he participates in this film near the end of his life.
“The intimacy we have with the families is incredible. I needed to feel and fear the disease. I did, and there were moments when all of us cried including me and my cameraman,” Barral told ARF. “We capture what it is like to have this type of AD. We also show the urgency and the commitment on the part of the researchers and the families.”
To allow the reality of life with the disease to come across as authentically as possible, Barral said he edited the footage into a documentary film that uses fewer cuts and longer shots than the fast-paced action docudramas viewers have gotten used to these days. It is great news to the field that this topic has caught the eye of CNN and will be before a world audience soon.
Barral’s film shows that this is a worldwide disease. Here are the show times Alzforum knows as of today. CNN International: Saturday, 1/29 and 2/12 at 8 a.m. and 4 p.m. EST; Sunday, 1/30 and 2/13 at 7 a.m. and 9 p.m. EST. In Spanish on CNN en Espanol: Saturday, 1/29 at 2 p.m. and 8 p.m. EST; Sunday, 1/30 at 3 a.m., 1 p.m., and 7 p.m.; Wednesday, 2/2 at 7 a.m. and 1 p.m. EST. View the film’s trailer at the CNN website.—Gabrielle Strobel.
I doubt you will deal with the issue raised (denial manifested as personal attacks are much more fun), but can you suggest another possibility--differing from overwhelming and unabated skepticism--as to why the long term pps/market-cap trend has been a steady downward trajectory?
Dunno--Jus don't aks Stoll er Varney, lol. eom.
Try hitting the send button, you silly goose!
Because Varney is an idiot, lol:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=58725535
Word. In the absence of accurate TA and effective medicine, behold miracles :)