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Mugur...Thanks again for the welcome.
You do place a heavy and impossible task on my shoulders though. If I find AAPL at $1.00, I'll buy a hundred contracts myself and then let you in on it. Okay?
G' day Mate,
Aussie
kool...Upon checking the SBUX charts, the only year it hit low in October was in 2004. Don't think the bottom out effect will mean much this year. And, I certainly wouldn't want the bottom to stretch out that long.
G' day Mate,
Aussie
Interesting BLOG:
bloggingstocks:sbux
June 04, 2007: 09:08 PM
It was forty years ago (yesterday) that global music learned to play
Posted Jun 2nd 2007 4:08PM by Richard Driver
Filed under: Products and services, Launches, Consumer experience, Starbucks (SBUX), Marketing and advertising, Columns
Yesterday was the fortieth anniversary of the release of The Beatles' Sgt. Pepper's Lonely Hearts Club Band (it was actually 40 years ago today in the United States). To celebrate the anniversary, The Beatles' website launched a new mini-site for the album. Meanwhile, numerous news agencies and online sources commented on the anniversary, but where these news pieces fall short -- and I admit I have not read them all -- is that they fail to remember just how "landmark" the actual release was in London. It basically went on for the entire weekend, which this weekend in 2007 happens to mirror exactly with 1967.
The release culminated in a performance of the title song by Jimi Hendrix at Brian Epstein's theater a mere two days after the album was released. As the manager of The Beatles, Epstein had access to the album long before it was released and also entertained other musicians and artists with listening parties. Listening parties for the general public would have been held in record stores and people's homes. With the influx of digital technology and digital devices (like MP3 players) and the "traditional" record store's continual fall from existence, what we think of as a listening party could just be you or me alone with our headphones on. In that way an album like Sgt. Pepper would not be a very global event, even if a large audience has access to it. Our conception of the album as a device to bind us together in a moment has been lost.
When you think about Sgt. Pepper though, it's hard to disconnect it from the Summer of Love and everything else going on in 1967. That is not an altogether bad thing, but remember that even The Beatles as individuals did not stay with the album for long. As a group they moved into new projects right away (the One World performance of "All You Need Is Love" and the Magical Mystery Tour film), but in the 1970s Lennon especially would write a song that bashed the album and especially McCartney's influence in it. More recently Ringo Starr has commented that he preferred the album's predecessor and follow-up. As the artists and performers of Sgt. Pepper we should not expect them to have stayed with the album for too long. After all, it took them six months to create it, which in 1967 was an extremely long time to produce an album.
But, the anniversary has now come and gone, and unfortunately there were no large-scale re-listening parties or live broadcasts attempting to re-perform the material. In the United Kingdom, there is a celebratory radio program but the second half will not air until Paul McCartney's birthday on June 18. We will not continue to celebrate the release today or tomorrow, but maybe when the new Paul McCartney album, Memory Almost Full, is released Tuesday we can enjoy a taste of how binding and global music can be. Starbucks Corp. (NASDAQ: SBUX) is planning to play the album all day (repeating) in over 10,000 stores worldwide, allowing fans and coffee-drinkers in 29 countries "to discover the new album in a single day."
According to Ken Lombard, the president of Starbucks Entertainment and the man who oversees the operation of its Hear Music label, "The Global Listening Event is one example of how we are bringing back the sense of event surrounding new releases, allowing fans to discover new music in a very personal way." This is a bold plan in the music industry. As mentioned, the digital growth in the music industry leans another way, but if a coffee chain can recreate the feel of a record store, our global connections to music like Sgt. Pepper might not be lost.
It's hard to guess if the "new" campaign will be a success in a world dominated by digital growth, but if Starbucks can release an album the way Sgt. Pepper was released in 1967, how we consider the music may change. It's not at all coincidental that the product going up for global sale is the new Paul McCartney album either, and as commented so many times before the connections may be mere marketing ploys. Whatever the motivation, the idea of a global connection to music outside the internet is about to be retried. If you don't want to take part, I suggest staying away from Starbucks on Tuesday. I'll be there however.
It will be interesting (getting back to stocks) to see if Starbucks has a hit with this but if it works at all it could be very big for Starbucks. Alas, Paul McCartney of today doesn't have the following the Beatles had in 1967 but this looks like a great move for Starbucks- at little cost they bring lots of people to their stores to buy music and coffee drinks.
Michael Schneider is webmaster of http://www.Barrelomoney.com where Starbucks is on the Barrel View list of stocks mentioned in the free Barrel View mailing which you can receive by signing the Private Guestbook there.
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G' day Mates,
Aussie
AAPL finished up $2.92. WOW! The Oct Call:
QAAJD 12.60 +1.80 12.50 12.60 1,428 9,328 Trade 120.00
Still PLENTY of upward movement on this one.
G' day Mates,
Aussie
Jagman...I do enjoy your posts immensely and often quote you on "The Board whose name we shall not use." Keep up the good work.
The email I sent you in regards to the "complete" phone call with Brian, I agree with you and the Megster on. Has to be taken with some salt and, a bit more than a grain. FASC's history hasn't really given investors enough confidence to trust him completely.
Aussie
rj2...After your last call, I tried to call Cal and found out he was no where near the office and hadn't been. So I called and talked with Brian for a spell. It was he that informed me that FASC would never do a three-in-one PR. They'd much rather do three separate PRs. I do rather chat with them every once in a while. Especially when I read anything that doesn't sound like FASC's way and might need a bit of clarification.
The Prince George thing just might be a bit bigger than some think.
Of course...
IMO.
Aussie
AAPL up $1.42 so far. The Oct Call
QAAJD 11.50 +0.70 11.60 11.80 1,195 9,328 Trade 120.00
the call as of the earlier post:
QAAJD 10.80 -------0 10.60 10.80 ------0 9,328 Trade 120.00
G' day Mates,
Aussie
Eric...Good posts.
Nokia has to watch AAPL this month. Apple IPhones hit the air last night and were seen by millions on TV. Right now the
QAAJD 10.80 0 10.60 10.80 0 9,328 Trade 120.00
Call is the option play of the month.
Will see how that plays out and what it does to NOK, Mot and the others.
G' day Mate,
Aussie
Watch! This should be the call of the month.
QAAJD 10.80 0 10.60 10.80 0 9,328 Trade 120.00
It's Apple(AAPL). The IPhone commercials hit the air last night and were run a couple of times.
G' Day Mates
Aussie
Hello Board. Nokia has done me rather well in trading. And, I intend to not only hold the shares I have for long term; but, to contantly trade Nokia Call Options.
Had a great start for the day.
Had some July 07 30 calls that I had gotten for $.05. Sold some earlier for a little gain and had a few mone contracts left. Just sold them for $.30. Would have liked to held them a little longer, but; that's like playing with a loaded gun. July is just around the corner and it could also dive. Sometimes it's hard to keep those twin sirens "fear and greed" from screeching in your ear and toying with your investment emotions.
G' day Mates,
Aussie
Encysive Invades Canada
By Brian Lawler June 1, 2007
Rule Breakers pick Encysive Pharmaceuticals' (Nasdaq: ENCY) quest to gain North American marketing approval for Thelin has received some good news.
The U.S. hasn't yet granted Thelin such approval, with an FDA decision expected in two weeks. But yesterday, Canada gave the drug a thumbs-up to be marketed for the treatment of pulmonary arterial hypertension (PAH).
Canada's population of only 33 million may seem like a small market for pharmaceuticals. But our northern neighbor is actually the world's eighth-largest such market, with sales exceeding $15 billion in U.S. dollars. Because drugmakers like Encysive generate income from high margins for their compounds, rather than a large number of prescriptions, they can still thrive in less populous countries.
Encysive estimates that PAH afflicts anywhere from 100,000 to 200,000 people in North America and Europe. If the two markets are roughly equal in size, and Canada accounts for approximately 10% of the North American market, that puts the drug's Canadian market potential at 5,000 to 10,000 patients. Thelin's actual potential is probably much smaller, though, considering that it's only indicated for patients in the more serious stages of the disease. Many of these patients are already on effective therapies, and probably won't switch to Thelin unless their current treatment fails.
Thelin has already been approved in the European Union, Australia, and other countries worldwide. Remember that the addition of Canada's stamp of approval will have no effect on the drug's odds with the FDA in the next two weeks.
It's also worth mentioning that even if Thelin fails to gain U.S. approval, Encysive's shares aren't necessarily overvalued, at a $275 million market cap. Whatever happens in the U.S., investors can at least be happy for a little while, as Encysive plants its flagship drug in Canada.
-----------------
G' day Mates,
Aussie
Great start for the day.
Had some July 07 30 calls that I had gotten for $.05. Sold some earlier for a little gain and had a few mone contracts left. Just sold them for $.30. Would have liked to held them a little longer, but; that's like playing with a loaded gun. July is just around the corner and it could also dive. Sometimes it's hard to keep those twin sirens "fear and greed" from screeching in your ear and toying with your investment emotions.
G' day Mates,
Aussie
Gosh! I think I'm in love already.
Aren't men fickle. ;)
G' day Mate,
Aussie
Sherri...I clicked on your name and your Profile came up. Right below it, it has in Big Blue Letters "Add Person Mark " I clicked on that and bingo, you got another member mark added to your count. Now you have "PeopleMarked By: 3"
G' day Mate,
Aussie
Starbucks Insider Action:
http://www.insider-monitor.com/reports/insider-buys-20070531.html
G' day Mates,
Aussie
Swizzer...Some judge, he didn't even give me a silver star yet (i.e.- member mark). However, you can be sure we will do our combined best to get the latest info to all. Surf will be handling the charts also, which at present I do not know how to do on the boards.
As for the pull back. Very expected. ENCY who got Canadian approval yesterday also pulled back. The reason, I believe, is due to the market not being that all interested in approvals with little pharmaceuticals. So, it waits for the more important judge (sorry Surf)of these companies, that being sales. The quarterlies will help out there or any PRs demonstrating good to better sales activity. But, in the meantime, the PPS should bounce around a little.
G' day Mate,
Aussie
Surf...Glad you did.
G' day Mate,
Aussie
Sherri...Don't too disappointed in the pullback. It's not unusual for a pullback as institutional investors, etc. usually want to wait for sales results to pour in. More activity occurs right before the quarterly report and then the real action starts after it. Especially with a penny stock.
Also, lets trade member marks. I just gave you one.
IMO.
G' day Mate,
Aussie
surf1944...Congratulations on being the new board monitor. I will assist any way I can with updates on Avanir.
G' day Mate,
Aussie
drbio...Thank you. I own several Australian stocks; but, that is not among them.
G' day Mate,
Aussie
drbio45...Sorry to see you go, after all it was you that originally set up this board and we owe you a debt of gratitude for it.
I would like it if you could continue to update the charts, as I haven't a clue how to do it. Or, if you have instructions, please forward them and I'll give it a go.
As far as contacting the Ihub Administration, I think that's one they would prefer you to do yourself. However, I will alert them to your post. Also how to handle the emails to those who sign up.
Finally, I'd like to be the moderator.
Take care, have a great day and may all your stock picks make you wealthy.
G' day Mate,
Aussie
Swizzer...Makes one wonder about the up ticks yesterday. Good news is always welcomed. Lets hope today's news puts it above $4.
G' day mate,
Aussie
Might want to jump on this quick. ENCY has options.
Press Release Source: Encysive Pharmaceuticals Inc.
Canadian Health Authority Approves THELIN (Sitaxsentan Sodium) for Pulmonary Arterial Hypertension
Wednesday May 30, 5:46 pm ET
First Selective Endothelin A Receptor Antagonist, First Once-Daily Oral Treatment
HOUSTON, May 30, 2007 (PRIME NEWSWIRE) -- Encysive Pharmaceuticals (NasdaqGM:ENCY - News) today announced that Health Canada's Therapeutic Products Directorate has approved THELIN(tm) (sitaxsentan sodium) 100 mg tablets.
ADVERTISEMENT
THELIN is indicated for the treatment of primary pulmonary arterial hypertension (PAH) and pulmonary hypertension secondary to connective tissue disease, in patients with World Health Organization (WHO) functional class III who have not responded to conventional therapy. THELIN is also indicated in patients with WHO functional class II who did not respond to conventional therapy and for whom no appropriate alternative can be identified.
THELIN is the first selective endothelin A receptor antagonist (ETRA) available, and the only once-daily oral treatment approved for PAH.
PAH is estimated to afflict approximately 100,000 to 200,000 people in North America and Europe. The disease is characterized by high blood pressure and structural changes in the walls of the pulmonary arteries, the blood vessels that connect the right side of the heart to the lungs. As these arteries become increasingly constricted, blood flow and oxygenation may be inadequate to meet the body's demands. The heart must then pump harder to overcome the resistance, and patients become susceptible to heart failure.
``The approval of THELIN represents an advance in the treatment options available for PAH patients in Canada,'' commented David Langleben, M.D., Professor of Medicine, McGill University and Director of the Center for Pulmonary Vascular Disease, Jewish General Hospital, Montreal. ``THELIN's safety and efficacy profile and once-a-day oral formulation make it an attractive therapeutic option, and I look forward to its commercial availability.''
``THELIN has demonstrated a unique benefit for individuals who have developed PAH as a result of a connective tissue disease, such as scleroderma,'' said Janet Pope, M.D., Professor of Rheumatology, University of Western Ontario and Director, Division of Rheumatology, St. Joseph's Health Centre, London, Ontario. ``As a clinician, I welcome any new treatment that may help these particular patients, as they are a more difficult group to treat.''
THELIN's approval is based on the largest database of patients with PAH ever assembled in an original Canadian New Drug Submission, with more than 1,000 PAH patients receiving THELIN. Encysive received European Union marketing authorization for THELIN in August 2006, marketing approval from the Australian Therapeutic Goods Administration in March 2007 and the drug is currently under evaluation by the Food and Drug Administration (FDA) in the United States.
``This approval is another important step in our effort to commercialize THELIN worldwide,'' stated Bruce D. Given, M.D., President and Chief Executive Officer of Encysive Pharmaceuticals. ``We're extremely proud to have achieved this milestone and look forward to bringing THELIN to PAH patients in Canada.''
THELIN(tm) (Sitaxsentan Sodium) Canadian Marketing Authorization Highlights
The Canadian market authorization was based on submitted data from quality (chemistry and manufacturing) studies, as well as data from non-clinical and clinical studies. Two randomized, double-blind, multi-centre, placebo-controlled studies (n=425) were conducted to demonstrate efficacy and safety. Compared to placebo, treatment with THELIN resulted in a significant increase in exercise capacity. The placebo-corrected increases in six-minute walk distance compared to baseline were 35 meters and 31 meters for the two pivotal studies. Compared to placebo-treatment, THELIN demonstrated improvements to the cardiac index, pulmonary vascular resistance, and systemic vascular resistance after 12 weeks of treatment. Compared to placebo-treatment, THELIN improved functional class. A significant reduction in the rate of clinical worsening was also reported in patients treated with THELIN.
In the STRIDE program, THELIN 100 mg was shown to significantly improve exercise capacity, as measured by improvement in six-minute walk distance, including in patients with connective tissue disease. THELIN was also shown to reduce patients' PAH symptoms (improvement in WHO/NYHA functional class) and improve PAH hemodynamic status. Survival of patients was 96% at one year in the overall patient population and 98% in patients with PAH secondary to connective tissue disease.
Important Safety Information
Like other ETRAs, THELIN is teratogenic, and pregnancy must be excluded before the start of treatment and prevented thereafter by the use of a reliable method. Monthly pregnancy tests during treatment with THELIN are recommended. THELIN has a potential for liver toxicity. Testing of liver enzymes is required prior to the initiation of THELIN and monthly thereafter. In placebo-controlled clinical trials, the most commonly reported adverse events with THELIN treatment were headache, peripheral edema, nasal congestion, nausea, constipation, epistaxis, insomnia, prothrombin time prolonged and international normalized ratio (INR) increase. Because THELIN inhibits the metabolism of warfarin, a dose adjustment is needed when co-administered with THELIN. THELIN is contraindicated in patients receiving cyclosporine A, patients with mild to severe hepatic impairment (Child-Pugh Class A-C), patients with elevated liver aminotransferases prior to starting treatment (elevation in liver enzymes to levels greater than 3 times the upper limit of normal), lactating patients, or patients with hypersensitivity to the active substance or any excipients.
THELIN(tm) (Sitaxsentan Sodium) Overview
THELIN is an endothelin A receptor antagonist, a small molecule that blocks the action of endothelin, a potent mediator of blood vessel constriction and growth of smooth muscle in vascular walls. Endothelin receptor antagonists may prove to be effective in the treatment of a variety of diseases where the regulation of vascular constriction is important. THELIN is 6,500-fold selective in the targeting of the endothelin A receptor versus the endothelin B receptor. Selective endothelin A receptor antagonism has been shown to increase blood flow and reverse vasoconstriction in human clinical pharmacology studies.
For more information, please visit http://www.encysive.com.
About Encysive Pharmaceuticals
Encysive Pharmaceuticals Inc. is a global biopharmaceutical company engaged in the discovery, development and commercialization of novel, synthetic, small molecule compounds to address unmet medical needs. Our research and development programs are predominantly focused on the treatment and prevention of interrelated diseases of the vascular endothelium and exploit our expertise in the area of the intravascular inflammatory process, referred to as the inflammatory cascade, and vascular diseases. To learn more about Encysive Pharmaceuticals please visit our web site: http://www.encysive.com.
The Encysive Pharmaceuticals Inc. logo is available at http://www.primenewswire.com/newsroom/prs/?pkgid=843
This press release contains ``forward-looking statements'' within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are subject to certain risks, trends and uncertainties that could cause actual results to differ materially from those projected. Among those risks, trends and uncertainties are market acceptance of THELIN(tm) in Canada and the actual rate of acceptance; the speed with which pricing and reimbursement approval and product launch may be achieved in Canada; competitive product developments in the PAH disease market in Canada that may affect THELIN(tm); our ability to protect our patents and other intellectual property for THELIN(tm), as well as more specific risks, trends and uncertainties facing Encysive such as those set forth in its reports on Forms 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks, trends and uncertainties, any or all of these forward looking statements may prove to be incorrect. Therefore you should not rely on any such forward looking statements. Furthermore, Encysive undertakes no duty to update or revise these forward-looking statements. The Private Securities Litigation Reform Act of 1995 permits this discussion.
Contact:
Encysive Pharmaceuticals
Investors:
Ann Tanabe, VP, Investor Relations and Corporate
Communications
(713) 796-8822
The Trout Group
Marcy Strickler
(646) 378-2927
Media:
BMC Communications
Dan Budwick
(212) 477-9007 ext. 14
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G' day Mates,
Aussie
AVANIR Receives FDA Approval for New Formulation of Currently Marketed Antipsychotic Drug FazaClo
AVANIR Pharmaceuticals (NASDAQ:AVNR) today announced that it has received marketing approval from the U.S. Food and Drug Administration (FDA) for a new formulation of the currently marketed antipsychotic drug FazaClo® (clozapine, USP) Orally Disintegrating Tablets. The new formulation provides bottle packaging and a new 12.5 mg dosage strength, in addition to 25 mg and 100 mg dosage strengths. Previously FazaClo was only available in 25 mg and 100 mg dosage strengths in special blister packaging. The new formulation of FazaClo in bottles is expected to be more convenient for health care professionals and patients, and will be available in pharmacies shortly.
"The new formulation and packaging should improve the utility of FazaClo and make it easier to offer to patients within my practice," said Michael J. Reinstein, M.D., Director of the Uptown Research Mental Health Center in Chicago. "Having the flexibility of the new 12.5 mg dose will also provide a wider range of dosing options to better match patients with the appropriate dose given the severity of their condition and the desired drug benefits."
AVANIR received an approvable letter in January 2007 for this new formulation of FazaClo. Final approval was granted after addressing the FDA concerns raised in that letter.
About FazaClo
Of the estimated two-and-a-half million Americans who suffer from schizophrenia, approximately one-third are termed treatment-resistant because they derive little or no benefit from conventional antipsychotic medications. FazaClo is the only orally disintegrating form of clozapine for the management of severely ill schizophrenic patients who fail to respond adequately to standard schizophrenia drug treatments. FazaClo is also indicated for reducing the risk of suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at risk for suicide. FazaClo is supplied as an innovative orally disintegrating tablet that uses proprietary formulation technologies licensed from CIMA LABS INC. FazaClo has a pleasant mint flavor and is designed to disintegrate in the mouth in about 30 seconds and is swallowed reflexively in saliva. The benefits of an orally disintegrating tablet can be important in treating a disease such as schizophrenia where patient non-compliance is a significant problem often leading to relapse and hospitalization. AVANIR maintains the FazaClo Patient Registry because of the risk of rare, but severe adverse events such as agranulocytosis and granulocytopenia associated with the use of clozapine. Prescribing health care practitioners, dispensing pharmacists and FazaClo patients can be registered in the FazaClo Patient Registry, which will compare patient information against the National Non-Rechallenge Masterfile and maintain a continuing record of total white blood cell (WBC) counts and absolute neutrophil count (ANC) values and related information for patients who receive the FazaClo brand of clozapine. Please see full Prescribing Information including BOXED WARNINGS regarding agranulocytosis, seizures, myocarditis, dementia-related psychosis in elderly patients, and other adverse cardiovascular and respiratory effects at www.fazaclo.com.
About AVANIR
AVANIR Pharmaceuticals is focused on acquiring, developing and commercializing novel therapeutic products for the treatment of chronic diseases. AVANIR's products and product candidates address therapeutic markets that include the central nervous system, inflammation and infectious diseases. AVANIR currently markets FazaClo, the only orally-disintegrating formulation of clozapine for the management of severely ill schizophrenic patients who fail to respond adequately to standard drug treatments for schizophrenia. FazaClo is also indicated for reducing the risk of suicidal behavior in patients with schizophrenia or schizoaffective disorder. For full prescribing information and important safety information regarding FazaClo, please visit www.fazaclo.com. AVANIR's lead product candidate for the treatment of involuntary emotional expression disorder (IEED), Zenvia™, is the subject of an approvable letter from the FDA. Additionally, AVANIR recently completed a Phase III clinical trial of Zenvia in patients with diabetic peripheral neuropathic (DPN) pain, where the primary endpoint was met. AVANIR has an ongoing development program with Novartis International Pharmaceutical Ltd. for the treatment of inflammatory disease. The Company's first commercialized product, Abreva®, is marketed in North America by GlaxoSmithKline Consumer Healthcare and is the leading over-the-counter product for the treatment of cold sores. Further information about AVANIR can be found at www.avanir.com.
Forward Looking Statement
Statements in this press release that are not historical facts, including statements that are preceded by, followed by, or that include such words as "should," "estimate," "intend," "anticipate," "believe," "plan," "goal," "expect," or similar statements, are forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from the future results expressed or implied by such statements. For example, there can be no assurances that the new formulation of FazaClo will be successfully commercialized or that patients and caregivers will perceive the new formulation to be superior. Risks and uncertainties also include the risks set forth in AVANIR's most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and from time-to-time in other publicly available information regarding the Company. Copies of this information are available from AVANIR upon request. AVANIR disclaims any intent to update these forward-looking statements.
To be included on AVANIR's e-mail alert list; click on the link below or visit AVANIR's website: http://www.b2i.us/irpass.asp?BzID=958&to=ea&s=0
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G' day Mates,
Aussie
Here's one on ENCY going Global. Enjoy.
http://www.dallasfed.org/fed/annual/2006...
New Hope for Fighting Disease
Pulmonary arterial hypertension, a rare disorder involving extremely high blood pressure in the lungs' smallest arteries, afflicts an estimated 100,000 people in the U.S.—a number too large to ignore but too small to entice most drug companies.
Going global proved the way around this dilemma for Encysive Pharmaceuticals. By expanding the number of potential patients, the international market gave the Houston-based firm the critical mass it needed for Thelin, its brand name for sitaxentan sodium.
Bruce Given
Bruce Given
"If you are going to put in all the effort to build out an infrastructure, you really have to have enough patients to make it worth your while," says Encysive president and CEO Bruce Given.
Pulmonary arterial hypertension is one of 5,000 so-called orphan diseases, those afflicting fewer than 200,000 people in the U.S. The larger market size inherent in globalization makes it far more likely that companies will embark upon the risky business of finding new treatments. "There are some orphan indications so small that to attain enough patients for regulatory filings, there is no other choice than to go global," Given says.
Developing drugs is extremely expensive. For every 1,000 that are synthesized, 100 go to animal testing, 10 to clinical trials and only one makes it to the marketplace. Without enough patients, pharmaceutical companies can't justify the time and expense needed for research and the approval process.
Encysive is currently selling Thelin in Europe and awaiting Food and Drug Administration approval in the U.S. Approval is also pending in Canada and Australia, and the company is casting its eyes toward Latin America and perhaps beyond.
Going into Europe doubled the potential market to 200,000 patients, big enough to make Thelin a viable drug. Encysive markets Thelin directly in Europe and plans to do the same in the United States and Canada. Elsewhere, it will probably partner with a big pharmaceutical company, which will handle distribution and pay Encysive royalties.
"I don't care who you are," Given says. "If you are in the business of developing a drug, you are doing so for a worldwide market. Increasingly, this includes looking for patients in places like India and China, which was not often done in the past."
Global markets will ease the way for future generations of orphan drugs. An increasingly integrated world economy may even become crucial to mainstream treatments.
"As regulatory authorities continue to seek greater assurances that drugs are safe and effective prior to approving them, patient numbers in dossiers are generally increasing," Given says. "As such, even in larger indications, companies often find it necessary or advisable to go global to enroll enough patients in their trials to meet regulatory expectations in a reasonable period of time.
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G' day Mates,
Aussie
Sherri...Thanks for posting that. I'll be sure to pass it along.
G' day Mate,
Aussie
Go figure. Stock is up by $.18 and there's no logical reason for it.
G' day Mates,
Aussie
Swizzer...It was my thinking a couple weeks ago this stock could well see $2.50. Especially with no news -- never helps a stock. Avanir always was a little too quiet and unfortunately won't change. They, for some reason, strongly believe in no news before its time.
However, the bouncing around of the PPS lately is baffling to say the least. Back up to $3.09 on nothing out there???
G' day Mate,
Aussie
A Biotech Triple Play
By Mike Havrilla May 29, 2007
Now that baseball season is in full swing with the unofficial, post-Memorial Day start of summer, I am offering biotech investors a triple play of their own for June: Panacos, Acadia, and Encysive.
As stated in an article earlier this month, Panacos Pharmaceuticals (Nasdaq: PANC) is conducting a phase 2b trial with liquid HIV treatment candidate bevirimat, the first of a new class of oral HIV drugs. Results are expected at the end of June. Data on trials using increasing doses will be reported in upcoming quarters.
Investors will want to tune into a presentation by Panacos' CEO this Wednesday at the Bank of America Health Care Conference for more information. With a market cap just over $200 million, Panacos is an attractive investment, if you believe as I do that the company is poised to resolve its oral formulation issues, which caused the stock to tank last year due to the time and money costs of a delay in clinical development.
Shares of Acadia Pharmaceuticals (Nasdaq: ACAD) skyrocketed in mid-March when the company reported positive top-line results from a phase 2 schizophrenia co-therapy trial combining its pimavanserin (formerly ACP-103) with either Risperdal or Haldol. Co-therapy advantages over the antipsychotics used alone included enhanced efficacy and an improved side-effect profile.
The company is now in the final stages of preparing to initiate its first pivotal trial in a phase 3 program with pimavanserin for Parkinson's disease psychosis, and a phase 2b trial with ACP-104 for schizophrenia. Acadia also completed a public offering last month that raised net proceeds of $96.1 million through the sale of 6.6 million shares of its common stock. Investors will have plenty of opportunities to stay updated on Acadia, as the company will be presenting at three upcoming investor conferences over the next month.
In the near term, Acadia appears poised to maintain its upward momentum, as most analysts are busy upgrading their price targets and ratings on the stock in anticipation of potentially lucrative licensing deals for both lead drugs, primavanserin and ACP-104. Obvious partners would be Risperdal's manufacturer, Johnson & Johnson (NYSE: JNJ), along with mental health drug giant Eli Lilly (NYSE: LLY). However, some analysts are skeptical, pointing out that phase 3 trials will present a more formidable tests.
Also, since ACP-104 is the major active metabolite of the existing antipsychotic clozapine, there are concerns over the potential for the serious side effects that have restricted clozapine to a last-line treatment. If Acadia's ACP-104 can jump this important safety hurdle, however, it has potential blockbuster status as it possesses a novel, additional mode of action in the brain.
Motley Fool Rule Breakers pick Encysive Pharmaceuticals (Nasdaq: ENCY) has a key date of June 15 for the FDA to decide on the company's drug Thelin in the treatment of pulmonary arterial hypertension (PAH). PAH is high blood pressure that is specific to arteries in the lungs, which causes undue strain on the right side of the heart. While my feeling is that Thelin will likely be approved, the labeling and potential competition from Gilead's (Nasdaq: GILD) ambrisentan (with approval likely for PAH three days later) will be the major challenges for Encysive.
Thelin also faces concerns over the drug's interactions with the widely used (among PAH patients) blood thinner warfarin. There also are concerns over liver enzyme elevation that could dampen the enthusiasm of physicians and the sales potential of the drug versus ambrisentan. As mentioned in an article earlier this month, Thelin is also expected to receive Canadian approval by the end of June, and negotiations with France's and Spain's health care systems over the price of the drug are expected to be completed later this year. Reimbursement is already complete in Germany and the U.K.
Even with the company's current market cap of just $260 million, I consider an investment in Encysive speculative in anticipation of likely upcoming approvals in the U.S. and Canada, in addition to increased European sales where the drug was approved for marketing last year. While Thelin may not have blockbuster sales potential, Encysive can still carve out a profitable niche for the drug given the low valuation being placed on the company by the market. At the very least, FDA approval would finally give Encysive shareholders a sigh of relief after long delays and previous disappointments for Thelin, while providing the company with a chance to develop a profitable business model. This, of course, assumes the FDA approves Thelin next month and that is far from certain as the drug has been turned down twice now.
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G' day Mates,
Aussie
At Your Service, China!
Russell Flannery, 05.26.07, 12:12 PM ET
CHENGDU - As trade battlefronts go, the five-star Jin Jiang Hotel in Chengdu, capital of Sichuan province in western China, exudes optimism for foreign business visitors.
The word "jin" suggests prosperity. A first-floor corridor boasts pictures of overseas visitors known to have had some success in the country. Among their number is politician-turned-entrepreneur Henry Kissinger, plus executives from Motorola (nasdaq: MOT - news - people ).
The atmosphere at a U.S.-Chinese business gathering here in China's far west this week couldn't have been more different to that surrounding the high-profile U.S.-Chinese economic talks in Washington. While U.S. legislators lambasted China's trade and exchange-rate policies, the 200 American and Chinese participants who turned out for the second U.S-China Business Matchmaking Conference here were upbeat about the economic outlook in the country and business opportunities.
More than the mood differed. Rather than exports of goods and exchange rates, Americans on the ground saw other priorities. "About 80% of U.S. GDP is in services, and services such as accounting, finance, legal and architecture are industries that Americans can come here and sell," said Barry I. Friedman, minister-counselor for commercial affairs at the U.S. Embassy in Beijing, who traveled to Chengdu to speak at the meeting.
To that end, Morgan Stanley (nyse: MS - news - people ) dispatched an executive director, Hui Li, from Hong Kong to pitch its help to Sichuan corporations. A speaker from global accounting giant KPMG described a fast-growing operation in Chengdu that opened last year and already has 60 employees; next year, it expects to have 200.
That wasn't the only gulf between U.S. politicians and attendees. Whereas most U.S. companies in southern China a decade ago looked to tap a low-cost workforce for export manufacturing, more than half of that group to respond to surveys these days said they invest primarily to tap into China's booming domestic demand and, what's more, are making money at it, said American Chamber of Commerce in South China President Harley Seyedin.
The Chinese-U.S. talks in Washington this week were useful in reducing tension, but the emphasis on shipping goods from the U.S. was "misplaced," Seyedin said.
The Chengdu conference coincided with one of the vast region's most important annual business gatherings, the Western China International Economy and Trade Fair. Chinese leaders are promoting trade and investment there to close the income gap with the more prosperous eastern seaboard provinces.
Land-locked Sichuan, mostly known around the world for its spicy food and pandas, is rich in tourism potential and is home to a relatively large and well-educated workforce. Its population of 87 million exceeds most European nations.
By Chinese standards, the Chinese-U.S. meeting was low on political platitudes that once overwhelmed such gatherings. That said, foreign and local guests alike were treated to a China National Symphony Orchestra Performance of "Soaring China," a piece "dedicated to the great rejuvenation of our motherland" and laden with traditional party propaganda concerning the absorption of Taiwan, plus other topical Communist Party thrusts.
"The day is coming after we have waited for so many years/The torch for the Olympic Games will be burning by the side of the Great Wall," the lyrics went. The work nationalistically concluded, "Soar high, soar high, soar high, my China!"
China's service industry holds promise for foreign companies because domestic ones born after decades of failed central government planning are still weak competitors. Financial services are hot in particular because so many Chinese companies are looking for help in selling stock overseas, and because so many of the country's newly rich are seeking ideas about what to do with their fortunes.
Franchising is another area with wide interest among American companies in China. Industry leaders like Starbucks (nasdaq: SBUX - news - people ) have set up shop in Chengdu and much of China already, amid an improving intellectual property environment. Allway of Seattle has managed to set up 11 Seattle Espresso coffee shops in Guangdong province and is looking to add some in Sichuan, said Vice President Tim Wen. Sichuan's weather and teahouse culture make it ripe for expansion, he adds.
Property investment was also a hot topic among American companies. Zhang Wei, New York real estate service firm Cushman & Wakefield's capital investments unit's managing director for China, was in Chengdu looking for property projects to invest in--one of several firms with the same idea. Probably not what export-minded U.S. politicians have in mind.
Consultant Mike Zelechowski said he once may have been closer to their ideal. A regional manager for Pacific Resources International of Laguna Hills, Calif., Zelechowski used to work with U.S. customers looking to sell machinery in China and recalls taking Chinese on buying missions in the U.S. in the 1990s.
But now, Pacific's main business is to help U.S. and other overseas companies set up production lines in China to make products for the local market. Pacific is working with an Israeli antenna producer, Galtronics, to set up a factory that will supply to Motorola (nyse: MOT - news - people ) locally. China is now the world's biggest market for mobile phones. It is moving up the industrial food chain and is richer, changing the opportunities that are to be found here, said Zelechowski.
Another problem for the U.S. Congress, said the American Chamber of Commerce in South China's Seyedin, is that many relatively small U.S. manufacturers that could succeed in China find the market too daunting and risky. To solve that, policymakers should look at Germany and other European governments that actively help those businesses get their feet on the ground by providing help with services such as low-cost office space. Otherwise, he said, "they won't come on their own."
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G' day Mates,
Aussie
Starbucks will be the next McDonald's
Posted May 25th 2007 8:12PM by Georges Yared
Filed under: Forecasts, Products and services, Consumer experience, Competitive strategy, Starbucks (SBUX), McDonald's (MCD)
Who has the audacity to say that ... even think it? Nobody is bigger than McDonald's Corp. (NYSE: MCD). After all, didn't McDonald's change the way we Americans eat? Didn't fast food and drive-thrus become the norm? Didn't McDonald's capture the hearts and, therefore, the appetite of every little kid with its Happy Meals and Ronald McDonald character? Didn't McDonald's even say that the world was ready for their menu and actually expand around the world? Even in France!
The answers to all the above questions is yes. McDonald's set the table (pardon the pun) to the way we view and eat fast food. Its success fostered major competitors like Burger King Holdings (NYSE: BKC), Wendy's International (NYSE: WEN) and Sonic Corp. (NASDAQ: SONC). It boasts a number of celebrities who have worked there in the past.
But McDonald's is still McDonald's. It has tried to be hip and cool by actually offering salads, but do you really go to a McDonald's to eat a salad? The movie Super Size Me did not do anything for its image either; yet McDonald's still marches on.
McDonald's went public in 1965 and a $2,250 investment back then would be worth nearly $2 million today. What a great success story; 31,000 units spread out over 119 countries. It is truly one great American export. The brand name alone is among the world's top 10 most recognizable and worth untold billions of dollars.
So, who is going to be bigger than McDonald's? The answer is Starbucks Corp. (NASDAQ: SBUX).
Starbucks went public in 1992 and has already captured a market capitalization value of $25 billion. McDonald's with a 27-year head start has a current market capitalization of $60 billion. (Market capitalization is all outstanding stock shares times the current market price.) Starbucks has already in place 11,500 units, and the story is just beginning. I believe Starbucks will hit the magical $100 billion market capitalization long before McDonald's does.
Starbucks, headquartered in beautiful Seattle, Washington, dominates and will continue to dominate the high-end, premium coffee business. Coupled with superb daily choices of the featured "coffee of the day," Starbucks has several different coffee concoctions and cold drinks as well. They also offer freshly baked items every morning. Okay, so far it is impressive ... but you said they would be bigger than McDonald's ... so what gives?
Starbucks is just beginning to offer warm breakfast sandwiches, available in only about 600 units, and lunch sandwiches, now available in 60% of their units. The additional annual revenues from breakfast and lunch sandwiches will be $60,000 per store. They are rolling it out systemwide, but in typical Starbucks fashion: one store at a time and do it to perfection. The "extra" $60,000 per unit when the roll out is complete will add up to $600 million in additional revenues for the company. Not bad for a few sandwiches!
Music CDs and movies in a DVD format have begun to find a happy home in Starbucks' stores. They could become the biggest seller of CDs in the nation and a major player in movie sales. Starbucks offers unique CDs, such as the Best of Ella Fitzgerald, the Best of Nat King Cole, and the like. These are titles we don't rush out to buy at our local Target stores or any other retailer. These are impulse buys, and the quality of the offerings is of the highest caliber. Movie DVDs are now rolling out systemwide as well. The selling space required is minimal and the margins are quite high.
All Starbucks stores offer wireless internet connectivity, which is a strong competitive feature. They also offer their customers the Starbucks Card, whereby a customer buys $25 worth of credit, and charges their coffee and other Starbucks items against the card. Once the $25 is spent, customers re-up for another $25 of credit. The whole process takes about 60 seconds to sell, and customers love the convenience and the ease of use. Starbucks is also testing a drive-thru window system where appropriate. The early results are stunning as the sales generated from the drive-thru concept are almost entirely incremental.
Starbucks has room for 17,000 to 20,000 units in the United States and another 18,000 to 20,000 units in the rest of the world. They will own and dominate the Chinese market. Starbucks is rolling out stores and by the end of the decade will have 6,000+ units in China alone! Its revenue and earnings growth has been consistently above 30% per year. As Starbucks will generate total revenues this year of about $8.2 billion and $9.8 billion next year, their growth rate has slowed to the low 20's%, but sustainable for the next four to six years. Starbucks, I estimate, will earn $0.90 per share in 2007, and $1.10 per share in 2008: strong and consistent earnings growth.
Starbucks has entered our vocabulary, like Kleenex or iPod. I hear so often people saying "let's go get a Starbucks", not a cup of coffee, but a Starbucks. They have arrived! They will become bigger than McDonald's, especially for their shareholders.
Since I wrote this original article back in early February, McDonald's has done quite well, seeing its stock appreciate from $44 to $51. McDonald's has put up some strong same-store sales recently and has offered a few new innovative menu selections to broaden its appeal. McDonald's is a mature company going through a nice growth phase within its existing units. The longer-term issue is market saturation therefore limiting unit expansion.
Starbucks stock has been range-bound between $28-32. Starbucks reported a good in-line March quarter and has reiterated its growth plans and initiatives.The company now has over 12,000 units on its way to global domination with a plan calling for more than 40,000 units.Starbucks has the win-win scenario of driving same-store sales higher with new product offerings AND tripling its store-unit base over the next decade. Cash flow from operations provides more than enough growth capital. (As an aside, Starbucks is now exclusively offering the new CD by Paul McCartney)
As the years go by we will witness Starbucks become bigger than McDonald's.
From:bloggingstocks:sbux
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Trust all had a great holiday week end.
G' day Mates,
Aussie
Here are 2 of CI's options for tday:
CIFM 3.00 -0.20 3.20 3.50 1 504 Trade
CIFN 1.45 +0.25 1.30 1.50 38 890 Trade
CIFO 0.55 +0.10 0.40 0.55 10 763 Trade
I wanted to post this so I'd be able to see how it reacts once it splits. June 4 should be the day it shows up as a split.
Now to get going.
G' day Mates,
Aussie
It's your option. Actually, I already have a couple of them in play. PHLY I just sold and made a little over $3K on, it was a 3-for-1.
Right now I have CI that was bought on 4/27 for $154.01 -- didn't get the options as it was in my 401K account; however, you can check the date and the option amount to see it is indeed a good play and it hasn't split yet. My problem with getting the options at the time, was all the amount in the options account was already allocated.
FMX is the latest and that's only gained $.25 on the options. However, the bigger play comes right after the 3-for-1 split occurs.
Your idea of paper trading the splits is an excellent way to go when not sure of a new strategy.
Lately, I've mentioned a whole slew of splits. Even now they can be traced as the splits haven't occurred.
Unfortunately, I can't do it today as the wife and I are going down to Atlantic City for a spell. With my next few suggestions I'll give a little more detail for the splits and see how it goes.
Take care and have a great day and fabulous week end.
G' day Mate,
Aussie
Looks like another good options "CALL" play. Express Scripts Inc. said Wednesday its board of directors approved a 2-for-1 stock split.
The split will given in the form of a dividend on June 22, for shareholders of record as of June 8. Shareholders will receive an additional share for each share already held.
The news of the split came out after the markets closed.
G' day Mates,
Aussie
Hop-on Delivers U.S. Patent and Trademark Appeal Victory at Annual Shareholders Meeting
BUSINESS WIRE
IRVINE, Calif.--(BUSINESS WIRE)----HOP-ON, INC. (Pink Sheets:HPNN) announced today the United States Patent and Trademark Trial and Appeals Board decision was a major victory for shareholders. The lawsuit filed last year by PalmSource (NASDAQ:PALM) unlawfully prevented the Company's use of their approved trademark, "Graffiti Wireless" resulting in undisclosed damages. The court determined Palm's "improperly obtained judgment invalid" and suspended all claims in violation of Trademark Rule 2.119. This victory allows Hop-on future market use of Graffiti and opens the floodgates for litigation. USPTO, Case No. 91169665, PalmSource v. Hop-on, Inc. 2007. The legal battlefield is all too familiar for Palm when it comes to use of the Graffiti name. The court who found the Trademark violation of rival Xerox's handwriting recognition of Graffiti last year resulted in damages paid by Palm over $22 million.
The Company announced a Board meeting scheduled for July in Paris, France and promised to deliver fully reporting status and long-awaited preliminary gaming approval to shareholders. The new corporate headquarters enable Hop-on's Skye-gaming proposal the physical presence abroad necessary for gaming license approval.
Peter Michaels, President of Hop-on, stated, "The contract negotiated with GBM provided a gateway into an exclusive niche market only penetrated by smaller entities. The trust and respect absent in our uneasy global market can be achieved by realizing corporate profit margins come at the end of the relationship, not the beginning. The necessity for strict interpretation of gaming regulations both at home and abroad prevent disclosure of pending gaming applications by our newly acquired subsidiary. I am going to listen to my attorneys this time and constantly remind myself I am just a guy who got lucky."
Hop-on will be fully audited within the next 90 days and will release gaming applications and financial statements at the Board meeting in July pursuant to whatever law we would not want to break.
This news release includes forward-looking statements regarding, among other things, the Company's business and financial plans, strategies and prospects. Although the Company believes that its plans, intentions and expectations reflected in or suggested by these forward-looking statements are reasonable, it cannot provide assurance that it will achieve or realize these plans, intentions or expectations. Forward-looking statements are inherently subject to risks, uncertainties and assumptions. Many of the forward-looking statements contained in this news release may be identified by the use of forward-looking words such as: believe, expect, anticipate, should, planned, will, may, intend, estimated, and potential, among others. Important factors that could cause actual results to differ materially from the forward-looking statements made in this news release include market conditions and those set forth in any reports or documents that the Company may publicly file from time to time. All forward-looking statements attributable to the company or a person acting on its behalf are expressly qualified in their entirety by this cautionary language.
Hop-on, Inc.Danny Coleman, 949-756-9008
© Business Wire 2006
05/23/2007 13:27 ET
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Problem is one cannot buy them through Scottrade.
G' day Mates,
Aussie
SEI Investments Co. (SEIC) on Wednesday declared a 2-for-1 stock split, payable June 21 to shareholders of record as of June 11.
This could be a real sprouter, as the stock appears also to be forming a double base. Appears to be a good options call. Stock at $59.77.
G' day Mates,
Aussie
Mugur...Hard to figure. Here are the trades for that period:
AVANIR PHARMACEUTICALS - Nasdaq National Market: AVNR
Time & Sales most recent next page
Rec. Time Action Price Volume
2:30:40 PM Ask 3.45 1500
2:30:40 PM Trade 3.45 5000
2:30:18 PM Ask 3.45 1600
2:30:18 PM Trade 3.45 100
2:30:14 PM Trade 3.45 2150
2:30:12 PM Ask 3.45 3300
2:30:12 PM Trade 3.44 100
2:30:08 PM Trade 3.44 100
2:30:08 PM Bid 3.44 4200
2:30:08 PM Bid 3.44 4300
2:30:08 PM Trade 3.44 100
2:30:08 PM Ask 3.45 1600
2:30:06 PM Ask 3.45 1500
2:30:06 PM Trade 3.44 700
2:30:06 PM Trade 3.44 200
2:30:06 PM Trade 3.44 200
2:30:06 PM Trade 3.44 1000
2:30:06 PM Trade 3.44 100
2:30:06 PM Trade 3.44 1000
2:30:06 PM Trade 3.44 200
2:30:06 PM Trade 3.44 200
2:30:06 PM Trade 3.44 200
2:30:00 PM Ask 3.45 1300
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Yet, looking at the trades since, it has been about the same -- a real mixed bag.
Agree, no news is not good and, the price should come down a bit.
G' day Mate,
Aussie
Don't forget this is coming up...
Congress on Neuropathic Pain
Two Poster Presentations Scheduled for June 8 at 1:30 p.m. CET
AVANIR Pharmaceuticals (NASDAQ:AVNR) today announced Phase III data on the efficacy, safety and improvements in patient-centered outcomes in patients with diabetic peripheral neuropathic (DPN) pain treated with the investigational drug Zenvia™ (dextromethorphan / quinidine) will be presented in two scientific posters at the Second International Congress on Neuropathic Pain, being held in Berlin, Germany on June 7 to 10, 2007.
Both posters will be presented at Poster Session 1: Clinical – Pharmacotherapy on Friday, June 8, 2007, between 1:30 p.m. and 3:30 p.m. Central European time (CET).
"This scientific congress serves as a showcase for new developments in pain treatment. We are pleased that these data have been recognized as important by the congress organizers and accepted for presentation," said Randall Kaye, MD, Chief Medical Officer of AVANIR Pharmaceuticals.
The accepted posters are:
Poster number 1497: EFFICACY AND SAFETY OF DEXTROMETHORPHAN/QUINIDINE IN TREATING PAINFUL DIABETIC PERIPHERAL NEUROPATHY: RESULTS OF A PHASE III, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL
Poster number 1498: IMPROVED PATIENT-CENTERED OUTCOMES WITH DEXTROMETHORPHAN/QUINIDINE VS PLACEBO IN A PHASE III, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL INVESTIGATING PAINFUL DIABETIC PERIPHERAL NEUROPATHY
On April 18, 2007 AVANIR Pharmaceuticals announced positive top-line results from a Phase III study of Zenvia in patients with DPN pain. In the trial, two doses of Zenvia, 45/30 mg DMQ dosed twice daily (DMQ 45) and 30/30 mg DMQ dosed twice daily (DMQ 30), were compared to placebo based on daily patient diary entries for the Pain Rating Scale, which was the primary endpoint as defined in the Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA). Both Zenvia treatment groups had lower pain ratings than placebo patients (p =0.0001 in both cases). In this study, Zenvia also demonstrated statistically significant improvements in a number of key secondary endpoints including the Pain Relief Ratings Scale and the Pain Intensity Ratings Scale. Although not statistically powered to detect differences in the secondary endpoint of Peripheral Neuropathy Quality of Life Scale Composite score, the DMQ 45 patients showed a greater improvement than placebo patients (p=0.05) and the DMQ 30 patients showed a greater improvement than placebo patients (p=0.08). Overall, the safety data from this study were consistent with data from previous studies. The most commonly reported adverse events were dizziness, nausea, diarrhea, fatigue and somnolence and were mild to moderate in nature. A higher number of patients in the DMQ 45 and DMQ 30 treatment groups (25.2% and 21.0%, respectively) discontinued due to an adverse event than compared to placebo (11.4%). There were no significant differences in serious adverse events with 7.6%, 4.8% and 4.1% reported in the DMQ 45, DMQ 30 and placebo groups, respectively and no deaths occurred during the study.
About Zenvia
Zenvia is a combination of two well-characterized compounds, the therapeutically active ingredient dextromethorphan, and the enzyme inhibitor quinidine, which serves to increase the bioavailability of dextromethorphan. This first-in-class drug candidate is believed to help regulate excitatory neurotransmission in two ways, through pre-synaptic inhibition of glutamate release via sigma-1 receptor agonist activity, and through postsynaptic glutamate response modulation via uncompetitive, low-affinity NMDA antagonist activity. Zenvia is currently in development for the treatment of Involuntary Emotional Expression Disorder (IEED) and DPN pain.
In October 2006, the Company received an approvable letter for the treatment of Zenvia in IEED. To address safety concerns raised in the FDA's approvable letter for Zenvia for the treatment of IEED, the company intends to initiate a confirmatory Phase III study with a new lower quinidine dose formulation of Zenvia. In April 2007 AVANIR completed the first of two planned Phase III studies in diabetic peripheral neuropathic pain where all primary endpoints were successfully met. The Company is considering whether it would be necessary or advisable to study a similar lower dose of quinidine in the second Phase III trial being planned for DPN pain.
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It's a past news release but I thought it might be worth repeating. Especially since there is no other news out there.
G' day Mates,
Aussie
For those that play put options, AOC was downgraded this morning. So far has dropped $.68.
G' day Mates,
Aussie
Omnicom Group Inc. -- Tuesday its board has authorized a 2-for-1 stock split in the form of a 100 % stock dividend.
Shareholders of record on June 6 will receive one additional share for each shareheld. The stock split to be distributed on June 25.
Looks like a good option call.
G' day Mates,
Aussie