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***** DONT MISS THE BIG OPPORTUNITY *****
Urocidin (Bladder cancer) PIII results in 2Q 2010 .Urocidin has BLOCKBUSTER POTENTIAL !!!!
Bioniche Life Science (BNC.TO)
Market Cap: 105 Mio C$
Cash: 30 Mio C$
Price: 1,21 C$
Upcoming Milestones
2009/2010 Conditional license for E. coli cattle vaccine in the U.S.
2009/2010 Achievement of pre-commercialization milestone payments for
UrocidinTM
2010 First U.S. sales of E. coli cattle vaccine
2010 Results of refractory Phase III bladder cancer trial
2011 Belleville, ON vaccine manufacturing centre operational
Insider activity
http://canadianinsider.com/coReport/allTransactions.php?ticker=bnc
Urocidin Potential New Treatment for Bladder Cancer
http://www.associatedcontent.com/article/1939454/urocidin_potential_new_treatment_for_pg3.html?cat=70
Urocidin (Bladder Cancer) PII Results
http://www.medicalnewstoday.com/articles/139517.php
Discussion board of people dealing with bladder cancer and discussing BCG treatment and MCC
http://www.inspire.com/groups/bladder-cancer-advocacy-network/discussion/bcg-protocol/?page=1#replies
Crystal Research 18.02.2010
http://www.crystalra.com/pdf/BNC_2QFY10_Update_02-18-10.pdf
1,50 $ TGT by Haywood
http://www.haywood.com/pdffiles/BNCJul142009.pdf
SECTOR OUTPERFORM; Target: $1.50 Risk: SPECULATIVE
Partnership Agreement Puts BNC Back on Track
ALPHA: We see significant upside to investors. BNC's share price
reflects a value for the Animal Health division only - that is at 5x
2009 EBITDA or
.50/shr. We note the US$20M upfront from the Endo
agreement is worth ~
.25/shr alone. We disagree with the market that
the Human Health division with Urocidin is currently worth zero to BNC and investors
Bioniche shares
jump 34% on Endo taking up global rights
February 12, 2010 by biotuesday
http://biotuesday.ca/2010/02/12/bioniche-shares-jump-34-on-endo-taking-up-global-rights/
Humblehawk I am Captttam,
This sounds like a big big winner, Good God what this could save millions of people, do you know the timelines yet on how far along to get a FDA approval??
Captttam
Off Topic - sorry I cant reply privately since I am a free member so I went to a message of yours on a lightly used board with no mod to answer you- I do scan through the pennies who have been dropping in price- I scan the daily charts once per week and I do a 60min scan every evening. I end up with a list of about 10-15 stocks for each scan I do that look like they are in a pinch or starting one and then I monitor the 60mins through the day, and touch in on the daily ones maybe once a day each- havent been doing pinchers very long but I really like what I have learned and its been going quite well. YOu just have to be disciplined about getting a quality pinch, and to be patient to not jump in too early - and if you miss an entry - let it go and catch the next one as there are new ones forming on a 60min every day and a a couple new ones on the daily each week-
Good luck!
QUARTER RESULTS
XOMA LTD (XOMA) reported Q4 results ended December 2009. Q4 Revenues were $21.60M; -41.50% vs yr-ago; BEATING revenue consensus by +50.73%. Q4 EPS was 1c; -85.71% vs yr-ago; BEATING earnings consensus by +125.00%.
http://www.knobias.com/story.htm?eid=3.1.5c034089a6cfe609f381f5fc3c6f0cb018ddf0e5d2c1c3ef48fe91ceec1d5a18
re: Bladder cancer PIII results in 2Q 2010
Nice Research by Crystal
http://www.crystalra.com/pdf/BNC_2QFY10_Update_02-18-10.pdf
***AEMD*** next HOT BIOSTOCK!!!
***AEMD*** highlights !!!
@.33 now !!! GREAT BUY...imo
**some great developments:
1. Initiated a collaborative biomarker discovery program with the Center for the Study of Traumatic Encephalopathy (CSTE) at the Boston University School of Medicine and the Sports Legacy Institute (SLI).
2. Established Exosome Sciences, Inc. (ESI) as a wholly owned subsidiary of Aethlon Medical to leverage the discovery that our Hemopurifier® captures exosomes known to suppress the immune system in cancer patients.
3. Completed and reported on the "first-in-man" study of a medical device to treat the Human Immunodeficiency Virus (HIV), which demonstrated a 92% reduction of viral load and improved immune function resulting from short-term intermittent application of our Hemopurifier® in the absence of any antiviral drug therapy.
4. Entered into an agreement that extends studies of our Hemopurifier® with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) under a cooperative research and development
agreement.
5. Documented our Hemopurifier® effectively captures the current pandemic strain of the H1N1 Swine Flu Virus.
6. Reported compelling human clinical outcomes against Hepatitis-C virus (HCV) infection; then disclosed a data supported strategy to improve HCV cure rates; and subsequently discovered a clinical validation by Asahi Kasei Kuraray Medical (Asahi) that confirms moderate levels of viral filtration at the outset of standard of care (SOC) therapy can dramatically impact HCV cure rates.
7. Initiated a relationship with Kentucky Bioprocessing LLC (KBP) to establish the processes necessary to support large-scale production of the active affinity agents we immobilize inside our Hemopurifier®.
8. Executed a non-exclusive agreement with NextPharma Technologies
(Click Here for Website) to establish manufacturing of our Hemopurifier® under good manufacturing practice (GMP) requirements set forth in quality system (QS) regulations for medical device commercialization.
GTF =Approval this Week !!!!
Get in now before its too late !!!!
Cytomedix (AMEX : GTF )
Market Cap : 18,8 Mio$
Price : 0,50 $
Shares Out : 37,3 M
On August 7, 2009, Cytomedix, Inc. (NYSE AMEX:GTF) announced that it has submitted to, the United Sates of America’s toughest regulator, the Food and Drug Administration (FDA) a 510(K) for its AutoloGel™ Platelet Separation System. The 510(K) submission was made to obtain pre market approval from the FDA. We anticipate they will get a response from the FDA after 6 months, i.e. on or around February 7, 2010. However, the FDA may not give its decision on this date and there is no way to find out when it will, since the FDA is not bound by law to notify about decision dates for any submission, such as 510(K), related to medical devices.
US approval..NEXT WEEK
Up 10% today ...
http://investorshub.advfn.com/boards/board.aspx?board_id=13856
This is a real sleeper !!!! Please do your own Research .
Intelgenx Technologies (IGXT.OB)
MarketCap : 22 Mio US$
Price : 0,61 $
Shares Out : 33 M
Check out their fantastic Pipeline !
http://www.intelgenx.com/products/pipeline.html
IntelGenx Corp. (TSX-V: IGX)(OTC.BB: IGXT) ("IntelGenx") today announced that the New Drug Application filing for their antidepressant CPI-300 has been accepted by the U.S. Food and Drug Administration (FDA) for standard review. Pursuant to Prescription Drug User Fee Act (PDUFA) guidelines, IntelGenx expects the FDA will complete its review or otherwise respond to the NDA by February 6, 2010.
US approval for Once a day Tramadol(Best in Class) + PartnerShip any day now . This stock is an unknown gem ...
Up 26%
http://ih.advfn.com/p.php?pid=webchart&cb=1264014227&symbol=T^DND&period=0&size=19&volume=1
CIPHER WINS PATENT LITIGATION = 100% US APPROVAL VERY SOON !!!
Cipher secures summary judgment in the company's favour in pending patent litigation involving CIP-TRAMADOL ER
1/4/2010 7:00 AM - Canada NewsWire
http://www.stockhouse.com/tools/?page=%2FFinancialTools%2Fsn_newsreleases.asp%3Fsymbol%3DT.DND%26newsid%3D7580687
Cipher Pharma (DND.TO) (CPHMF.PK) << Canadian Stock !!!
Market Cap : 17 Mio$
Cash : 9 Mio$
Price : 0,71 $
Shares Out : 24 M
Pipeline
http://cipherpharma.com/web/main.cfm?docID=11
Great Article .. A must read
http://biotuesday.ca/2010/01/05/cipher-plans-to-license-in-new-drug-this-year/
Presentation
http://cipherpharma.com/downloads/DND_Presentation_BIO_Oct2009.pdf
Bladder cancer PIII results in 2Q 2010
Positive Results will push this stock to 5$ ++ ....Please do your own DD !!
Bioniche Life Science (BNC:TO)
Market cap 53 Mio C$
Cash 20 Mio C$
Price 0,61 C$
Insider activity
http://canadianinsider.com/coReport/allTransactions.php?ticker=bnc
Urocidin (Bladder Cancer) PII Results
http://www.medicalnewstoday.com/articles/139517.php
1,50 $ TGT by Haywood
http://www.haywood.com/pdffiles/BNCJul142009.pdf
SECTOR OUTPERFORM; Target: $1.50 Risk: SPECULATIVE
Partnership Agreement Puts BNC Back on Track
ALPHA: We see significant upside to investors. BNC's share price
reflects a value for the Animal Health division only - that is at 5x
2009 EBITDA or $0.50/shr. We note the US$20M upfront from the Endo
agreement is worth ~$0.25/shr alone. We disagree with the market that
the Human Health division with Urocidin is currently worth zero to BNC
and investors.
Great news out for EMIS...
http://finance.yahoo.com/news/Novo-Nordisk-Starts-Phase-I-bw-158662610.html?x=0&.v=1
Novo Nordisk Starts Phase I Trial with Long-Acting Oral GLP-1 Analogue
Emisphere earns $2 million milestone payment
Press Release Source: Emisphere Technologies, Inc. On Wednesday January 13, 2010, 2:30 am EST
CEDAR KNOLLS, N.J.--(BUSINESS WIRE)--Emisphere Technologies, Inc. today announced that Novo Nordisk has initiated its first Phase I clinical trial with a long-acting oral GLP-1 analogue (NN9924). This milestone releases a $2 million payment to Emisphere, whose proprietary Eligen® Technology is used in the formulation of NN9924.
GLP-1 (Glucagon-Like Peptide-1) is a natural hormone involved in controlling blood sugar levels. It stimulates the release of insulin only when blood sugar levels become too high. GLP-1 secretion is often impaired in people with Type 2 Diabetes.
The aim of this trial, which is being conducted in the UK, is to investigate the safety, tolerability and bioavailability of NN9924 in healthy volunteers. The trial will enroll approximately 155 individuals and results from the trial are expected in 2011.
There are many challenges in developing an oral formulation of GLP-1, in particular obtaining adequate bioavailability. NN9924 addresses some of these key challenges by utilizing Emisphere’s Eligen® Technology to facilitate absorption from the gut.
“We still have a long road with many challenges ahead of us before an insulin pill or a GLP-1 pill becomes a reality,” says Peter Kurtzhals, Senior Vice President and Head of Diabetes Research at Novo Nordisk. “But with the progress we have made so far I am convinced it is only a matter of time.”
Michael V. Novinski, President and Chief Executive Officer, Emisphere Technologies, says, “This milestone reflects a major achievement for our program and partnership with Novo Nordisk and is one small but significant step forward in the development of a successful treatment for Type 2 Diabetes. As a company, we are extremely encouraged by the progress to date and look forward to the future and the potential benefits this program may bring to the millions of patients being treated for this disease.”
In June 2008, Novo Nordisk and Emisphere entered into a development and license agreement to develop and commercialize oral formulations of Novo Nordisk’s proprietary GLP-1 analogues, using Emisphere’s Eligen® Technology. This is the first development milestone achieved by Emisphere under this agreement.
Fantastic New for Puramed
Market Cap 11 Mio$
Great News ..Check it out !!!!
http://finance.yahoo.com/news/PuraMed-BioScience-Begins-to-pz-3559931568.html?x=0&.v=1
EMIS =Rally has begun ...
EMIS = Another Top Pick 2010
Chart looks very bullish
http://seekingalpha.com/article/179100-a-window-of-opportunity-to-buy-emisphere
A Window of Opportunity to Buy Emisphere
When Emisphere's (EMIS) news release entitled "Emisphere Technologies Reports DMC Recommendation to Proceed with Phase 3 Clinical Trials with Oral Calcitonin for Osteoporosis and Osteoarthritis" hit the wires last week, it was the single biggest event in the company's history. If you weren't already totally up on the story the significance probably would have been lost on you. The Data Monitoring Committee based their recommendation to proceed upon "an assessment of safety and efficacy parameters."
Translation: that the drug is safe (should come as no surprise to anyone that read my previous articles) and that we are hitting our primary endpoints in both trials. This was absolutely huge news, which we greeted with open buy orders. It is my opinion that it is no longer a question of whether Oral Calcitonin will be approved for both indications or not; it is merely a question of timing, and the timing of approvals might be sooner than most are expecting.
Novartis (NVS) has been playing their cards close to their vest with the entire Oral Calcitonin program. In my opinion they are doing this because they know they have a huge winner on their hands and they want to keep the competition in the dark as long as possible; that is why we have yet to see any publication of data from the Calcitonin for Osteoarthritis Phase 2 trial that was completed almost 2 years ago.
I sincerely believe that when we start seeing some actual data from the Phase 2 trial people will be absolutely blown away by the results that will show significant widening of joint space width and a significant regrowth of cartilage. Novartis has said that they will wait for the completion of the US Osteoarthritis trial to file in the EU but I do not see why they would do this. I think that they will file in the EU in the early summer of 2010 and have approval in late 2010, which would mean commercial revenues much faster than people are anticipating.
The Osteoporosis trial also appears to be 2 full years ahead of the time-line spelled out on the clinicaltrials.gov website. We were not supposed to have our futility look until September 2011. Calcitonin is already a standard of care for Osteoporosis; we are just changing the delivery to oral so the shorter time-line would make more sense especially given the safety profile. I think that Novartis always had the option of going with a shorter study if the data were overwhelmingly good. I think that this is what is happening and that Novartis will be able to get FDA approval in late 2010 or early 2011; way ahead of schedule. This would mean commercial revenues from both Osteoporosis and Osteoarthritis start hitting in Q1 2011.
So if Oral Calcitonin is really going to get approved for both indications and it is going to happen a lot sooner than people expect then why is the fully diluted market cap of the company a mere $60 million?
There are two reasons. First, the secrecy and confidentiality of the Novartis partnership prevents Emisphere from clearly explaining the development of Oral Calcitonin. Investors must figure it out for themselves. Second, the last financing was managed very poorly and was very dilutive. There were two funds that bought a total of 5.2 million shares in the August financing and they got 100% warrant coverage. They appear to have been selling their shares and taking their risk capital off the table, keeping the warrants for profit. This would be carrying out a trading strategy rather than a fundamental strategy. They look at it and say we paid 70 cents for our investment so if we can sell our entire common stock position at an average of 70 cents or better we will have recouped all of our initial investment (or in this scenario even a little profit in addition) and we will still have the same amount of warrants as stock that we bought that are priced at 70 cents.
Therefore if the stock goes up we still make a killing on our warrants while already having taken the risk off the table. That is why the stock has not moved but I think that the sellers are getting down to tag ends. Get in now before the seller cleans up; I think this stock is going to be up substantially by the end of January(yes, next month) and it will still be dirt cheap as investors begin flocking to this opportunity.
Market Cap of 8 Million US$ is a big Joke !!!!!!!!!!!!!!!
LipiGesic™ M
LipiGesic™ M provides acute relief from migraine headaches, and contains the herbs feverfew and ginger as principal ingredients. PuraMed believes that its specific formulation of these herbs for its migraine remedy is unique and proprietary, providing relief from these severe headaches in minutes. The Company believes it will capture a material segment of the huge migraine headache remedy market. We believe that Americans spend in excess of $6 billion annually on headache pain relievers, and that over half of sufferers of migraine headaches rely exclusively on non-prescription medications.
We believe that at least 30 million Americans suffer from chronic migraine headaches with over 20 million of them having “severe” migraine conditions. Thus migraine headaches constitute a severe and disabling condition for millions of people. We further believe that the economic burden alone to the U.S. economy is in excess of $20 billion annually.
LipiGesic™ M is effective, available as a non-prescription remedy, without any known side effects, and affordable compared to more expensive migraine drugs based on prescription chemical formulations.
LipiGesic™ PM
LipiGesic™ PM is a new class of non-prescription sleep aid without any known side effects, and contains a proprietary blend of natural ingredients including Valerian, St. John’s Wort, and Chamomile. We believe that the proprietary blend of these ingredients provides an effective remedy for insomnia and other sleep disorders. The sleep aid market features products based primarily on chemical antihistamines.
Accordingly, the LipiGesic™ PM product provides a wide open market opportunity for an effective, natural alternative to prescription medications, which are somewhat addictive and often cause withdrawal symptoms and other side effects. We have priced LipiGesic™ PM as a premium sleep aid product, which provides us with a projected gross margin of approximately 80%. This large margin should leave us substantial room for ample introductory promotion, product allowances and other incentives conducive to achieving rapid market penetration.
Similar to the migraine remedy market, the market for sleep aid products represents a very large segment of the overall healthcare products marketplace. We believe that over half of all adults in the U.S. suffer from sleep disorders, and that many of them experience persistent insomnia. The National Center on Sleep Disorders has reported that there are as many as 70 million problem sleepers in the U.S. with many of them suffering from chronic sleep disorders. We believe that insomnia is second only to pain as a healthcare complaint.
Future LipiGesic™ Products
We have completed development of additional non-prescription products, which we intend to launch commercially over the next couple years after establishing a solid market for our initial two products. These other PuraMed products include:
LipiGesic™ H – provides relief for common tension headaches which afflict a majority of American adults from time to time. This remedy provides headache relief features a unique proprietary formulation of St. John’s Wort and common aspirin.
LipiGesic™ Smoker’s Pal – provides relief from the symptoms associated with nicotine withdrawal with the added benefit of an appetite suppressant.
LipiGesic™ RLS – provides relief of problematic leg cramps associated with Restless Leg Syndrome affecting a large segment of the population in the U.S.
LipiGesic™ GI – provides relief of symptoms associated with nighttime reflux disorders.
LipiGesic™ CS – provides fast relief for canker sore outbreaks.
Break out is comingggggggggggggg !!!!!!!!
GLTA
IGXT.OB
Market Cap : 18 Mio$
Price : 0,56 $
Shares Out : 33 M
http://www.intelgenx.com/_assets/pdf/Rodman-Renshaw-Sept-2009.pdf
Filed NDA with U.S. Food and Drug Administration (FDA) - on April 3, 2009 the Company and Cary Pharmaceuticals filed a New Drug Application (NDA) under CFR 21 paragraph 505(b)(2) for the CPI-300 antidepressant. CPI-300 is a new strength of a leading antidepressant that will provide a more convenient dosing option to patients with major depressive disorder ("MDD").
The NDA has been formally accepted by the FDA for standard review. Pursuant to Prescription Drug User Fee Act (PDUFA) guidelines, IntelGenx expects the FDA will complete its review or otherwise respond to the NDA by February 6, 2010.
Flu pandemic a big boon--and a bit bust
December 24, 2009 — 9:24am ET | By Tracy Staton
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* U.S. blames drugmakers for slow flu shots
* Brits investigate spread of resistant H1N1
* Low vax demand could threaten H1N1 profits
* Sanofi recalls pediatric H1N1 shots
* MedImmune recalls 4.7M doses of H1N1 vaccine
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Hard to believe, but the H1N1 "swine" flu pandemic only hit the public consciousness this past spring. That was when Mexico first announced it had toted up dozens of cases. And it wasn't till April 30 that the World Health Organization officially declared a pandemic. Of course, we've read so much by now about H1N1 and its "windfall" profits for makers of antivirals and vaccines that it's hard to remember just how much the spread of H1N1 changed Big Pharma's fortunes this year.
The pandemic forced the media--and the public--to focus on the positive side of the pharmaceuticals business for a change. The world waited on tenterhooks as vaccine makers developed a shot to ward off the H1N1 strain of flu, unsure at the time whether the pandemic virus would grow more virulent (it didn't) and whether it would, like most other flu pandemics, hit children, youth and young adults particularly hard (it did). And the world counted its blessings that antivirals such as GlaxoSmithKline's Relenza and Roche's Tamiflu were actually available, and that the companies could ramp up production quickly in an effort to meet demand. Headlines followed when intravenous versions saved some severely ill people--and were subsequently approved under emergency FDA measures.
Of course, there was a cloud around this silver lining; nothing is without its negative side. The seed strain of H1N1 proved difficult to grow at first, slowing down vaccine production. At first vaccine supplies fell short of demand; now some areas have surplus doses, so they're offering it to all comers, rather than just those on the priority list. The pandemic turned out to be less virulent than it might have been, which is good public health news, but not so great for vaccine makers who may have to take back doses from customers. And as the pandemic progressed, the efficacy of Roche's Tamiflu drew questions.
Now, H1N1 is winding down. Some virologists warn there might be a third wave of illness. But armed with vaccines, drugs, and lots of new data from on-the-fly studies of the new strain, the world feels ready to combat new cases. And so does the pharma biz.
Related Articles:
No pharma-haters in a pandemic
Roche, Glaxo ramping up on flu meds
Swine flu presents $4.9B opportunity for GSK
Swine flu could be FluMist's moment
U.S. blames drugmakers for slow flu shots
Sanofi recalls pediatric flu shots
Low vax demand could threaten H1N1 profits
Read more: http://www.fiercepharma.com/story/flu-pandemic-big-boon-and-bit-bust/2009-12-23#ixzz0adYj39Hd
Upcoming Events ..2 Presentation in 2010
http://www.investorawareness.com/default.asp
Upcoming Events
PuraMed BioScience Financial Luncheon Presentation
- Tuesday, January 19, 2010
- 12:00 pm (event details)
PuraMed BioScience Financial Luncheon Presentation
- Wednesday, January 20, 2010
- 12:00 pm (event details)
The recent pullback in the stock price presents an attractive entry point ahead of several catalysts in 2010 !
GLTA
Puramed (PMBS.OB)
Market Cap: 7,7 Mio$
Price: 0,65 $
Shares Out : 11,99 M (8,6 M Shares held by Insider)
Float : 2,6 Million
Why Puramed Bioscience Inc. (PMBS.OB) Should Be On Your Radar
PuraMed Bioscience, Inc. is a pharmaceutical company focused on developing and marketing a line of new, non-prescription medicines. These products target major consumer health needs, including the treatment of headaches, insomnia, and general pain. The company aims launch its first retail products within six months, and then leverage that success to become a leader in the Over-the-Counter (OTC) medicine marketplace.
Although PuraMed Bioscience is entering into a competitive market, the company’s products promise to bring innovation to the industry, allowing for faster absorption into the blood stream, greater effectiveness, fewer side effects, and lower dosage requirements. The first three products the company plans to introduce include: LipiGesic M™ (for acute relief of migraine headaches), LipiGesic H™ (for acute relief of tension headaches) and LipiGesic PM™ (for insomnia).
PuraMed is already sufficiently funded via private funding and ready to move forward with the execution of its comprehensive business plan. Recently BrokerBank analyst Philip Wright, CFA initiated investment coverage of the company and has rated the company as a “speculative buy”. Wright praised the company for running on a lean basis by keeping salaries reasonable and office overhead costs extremely low.
The share structure of the stock is also attractive with only 7,929,246 shares of common stock outstanding as of last month. PuraMed is also a fully reporting company, meaning the company must be audited by a PCAOB registered public accounting firm and must comply with the requirements of Sarbanes-Oxley. These requirements allow for greater transparency and the ability to attract a larger investor audience, subsequently enhancing shareholder value and providing greater access to capital for further growth.
With a management team bringing more than 80 years of combined industry experience, a product line addressing major healthcare needs with many competitive advantages, and a well thought-out business plan, this company is well on its way to success in the multi-billion dollar OTC medicine market. Continue to watch this company as it strives to dramatically improve the quality of life for millions of Americans.
About the Company
PuraMed was established to capture two unique opportunities. The first is to build a substantial and profitable business, rapidly, beginning with three products developed by its founders: LipiGesic™ M (for acute relief of migraine headaches), LipiGesic™ H(for acute relief of tension headaches) and PuraMed™ PM (for insomnia). Each of these is effective and addresses a very large OTC consumer market, collectively well over $2 billion in the U.S. Each product will be unique in its class .
Tremendous upside Potential
IGXT.OB
Market Cap : 18 Mio$
Filed NDA with U.S. Food and Drug Administration (FDA) - on April 3, 2009 the Company and Cary Pharmaceuticals filed a New Drug Application (NDA) under CFR 21 paragraph 505(b)(2) for the CPI-300 antidepressant. CPI-300 is a new strength of a leading antidepressant that will provide a more convenient dosing option to patients with major depressive disorder ("MDD").
The NDA has been formally accepted by the FDA for standard review. Pursuant to Prescription Drug User Fee Act (PDUFA) guidelines, IntelGenx expects the FDA will complete its review or otherwise respond to the NDA by February 6, 2010.
PDUFA Date 6 Feb 2010= BUY NOW
If you do your homework, you will clearly see that this stock will rise rapidly as soon as it gets noticed. Don't miss the boat !
IGXT.OB
Market Cap : 18 Million US$
Price : 0,56
Shares Out : 33 M
Great Pipeline
http://www.intelgenx.com/products/pipeline.html
IntelGenx Corp. Announces FDA Acceptance for Filing of NDA for CPI-300 Antidepressant
On Tuesday June 23, 2009, 6:00 am EDT
IntelGenx Corp. (TSX-V: IGX)(OTC.BB: IGXT) ("IntelGenx") today announced that the New Drug Application filing for their antidepressant CPI-300 has been accepted by the U.S. Food and Drug Administration (FDA) for standard review. Pursuant to Prescription Drug User Fee Act (PDUFA) guidelines, IntelGenx expects the FDA will complete its review or otherwise respond to the NDA by February 6, 2010.
"Formal FDA acceptance of the NDA clears the path towards review and approval of CPI-300 within the timeframe expected" said Dr. Horst G. Zerbe, President and Chief Executive Officer of IntelGenx. "We are especially pleased to note that the FDA has confirmed that our NDA was sufficiently complete to permit a substantive review. As CPI-300 represents our very first NDA, this is not only a testament to the expertise of our staff but also to the strength of our partners."
U.S. Health Officials Urge H1N1 Vaccination For All Groups
By Jennifer Corbett Dooren
Of DOW JONES NEWSWIRES
WASHINGTON -(Dow Jones)- Top federal health officials urged Americans to get vaccinated against the H1N1 influenza virus to prevent another wave of illnesses after the holidays.
"We finally have enough vaccine that for most of you, it's your turn," Health and Human Services Secretary Kathleen Sebelius said at press conference Thursday.
Illnesses from the H1N1 virus have fallen sharply in recent weeks with just 14 states reporting widespread influenza activity in the week that ended Dec. 5, down from 48 states that had reported widespread activity in mid-October. Health officials, however, fear there could be a resurgence of H1N1 illnesses starting in January following the holiday-travel season.
During the 1957-58 influenza pandemic there was a wave of illness in the late summer and early fall and then a decline before another wave of illness was seen in January and February. Officials are concerned the same thing could happen again and said getting vaccinated could prevent or slow the spread of another round of H1N1 illnesses. So far, H1N1 or swine flu has sickened at least 47 million Americans and killed nearly 10,000.
"We have the chance to lessen the impact or prevent a third wave," Sebelius said. The first wave of influenza started last spring before it waned over the summer and resurged after schools started in September and October.
Initially, H1N1 vaccines were limited to pregnant women, children, young adults and health-care workers, or the groups at the highest risk of becoming ill. Now with nearly 100 million doses of vaccine that have been shipped to the U.S. and more coming each day, many states have lifted those restrictions.
Drugstore chains like Walgreen Co. (WAG), CVS Caremark Corp. (CVS) and Rite Aid Corp. (RAD) have started offering H1N1 vaccine at some of their stores. Walgreen's said it would be offering the vaccine nationwide by the end of the month.
Thomas Frieden, director of the Centers for Disease Control and Prevention, said most influenza illnesses are being caused by the H1N1 virus and not the seasonal influenza strains. However, he said seasonal influenza strains usually don't start circulating until now with a typical peak in February.
The U.S. has ordered about 250 million vaccine doses from five companies with the largest producers being Novartis AG (NVS) and Sanofi-Aventis SA (SNY), although health officials said they don't think the U.S. will need that much and have given back a portion of an order so that it can be sold to other countries.
U.S. Health Officials Urge H1N1 Vaccination For All Groups
By Jennifer Corbett Dooren
Of DOW JONES NEWSWIRES
WASHINGTON -(Dow Jones)- Top federal health officials urged Americans to get vaccinated against the H1N1 influenza virus to prevent another wave of illnesses after the holidays.
"We finally have enough vaccine that for most of you, it's your turn," Health and Human Services Secretary Kathleen Sebelius said at press conference Thursday.
Illnesses from the H1N1 virus have fallen sharply in recent weeks with just 14 states reporting widespread influenza activity in the week that ended Dec. 5, down from 48 states that had reported widespread activity in mid-October. Health officials, however, fear there could be a resurgence of H1N1 illnesses starting in January following the holiday-travel season.
During the 1957-58 influenza pandemic there was a wave of illness in the late summer and early fall and then a decline before another wave of illness was seen in January and February. Officials are concerned the same thing could happen again and said getting vaccinated could prevent or slow the spread of another round of H1N1 illnesses. So far, H1N1 or swine flu has sickened at least 47 million Americans and killed nearly 10,000.
"We have the chance to lessen the impact or prevent a third wave," Sebelius said. The first wave of influenza started last spring before it waned over the summer and resurged after schools started in September and October.
Initially, H1N1 vaccines were limited to pregnant women, children, young adults and health-care workers, or the groups at the highest risk of becoming ill. Now with nearly 100 million doses of vaccine that have been shipped to the U.S. and more coming each day, many states have lifted those restrictions.
Drugstore chains like Walgreen Co. (WAG), CVS Caremark Corp. (CVS) and Rite Aid Corp. (RAD) have started offering H1N1 vaccine at some of their stores. Walgreen's said it would be offering the vaccine nationwide by the end of the month.
Thomas Frieden, director of the Centers for Disease Control and Prevention, said most influenza illnesses are being caused by the H1N1 virus and not the seasonal influenza strains. However, he said seasonal influenza strains usually don't start circulating until now with a typical peak in February.
The U.S. has ordered about 250 million vaccine doses from five companies with the largest producers being Novartis AG (NVS) and Sanofi-Aventis SA (SNY), although health officials said they don't think the U.S. will need that much and have given back a portion of an order so that it can be sold to other countries.
You are good with avoiding real persons with real questions! Wondered why you call yourself specialist!
Time to Buy !!!!!!!!!!!!!!!!1
Puramed (PMBS.OB)
Market Cap: 10,5 Mio$
Price: 0,85 $
Shares Out : 11,99 M ( 8,6 M Shares held by Insider)
Float : 2,6 Million
PuraMed Bioscience, Inc. (PMBS.OB) Targets Two Market Opportunities
PuraMed Bioscience, Inc., a non-prescription pharmaceutical company, believes it has identified huge and largely untapped market opportunities, and has laid out a solid plan to capture them. The company, based in Schofield, Wisconsin, was established with two specific goals in mind, representing these two OTC (over-the-counter) product opportunities.
The first objective is to rapidly build a substantial and profitable business based upon three OTC products already developed by the company founders. The products, designed for headache and insomnia relief, are each unique in their own class, and collectively target a $2 billion American market.
LipiGesic MTM is a proprietary formulation created for the acute relief of migraine headaches within minutes. LipiGesic HTM is designed to dramatically increase the speed and levels of relief of tension headaches, effective at low doses and with the fewest potential side effects. LipiGesic PMTM is a new class of OTC sleep aid containing a proprietary blend of ingredients for the quick and natural relief of insomnia.
The second, longer term objective is to establish a leadership position in the highly fragmented OTC natural and alternative health remedy market by introducing a new kind of product line. By applying hard science to natural products, PuraMed believes it can deliver products providing better performance while having fewer side effects.
The company also believes their products will benefit from the kind of effective opportunity identification and marketing that is largely absent in the natural OTC market. Promising research in the field often goes overlooked for years by large pharmaceutical companies. Through the effective use of clinical trials in conjunction with carefully timed and aggressive marketing, PuraMed is convinced that it can better reach a major part of the OTC market.
The two founders of PuraMed, Russ Mitchell and Jim Higgins, both have extensive experience in the successful sale and distribution of new health products, with novel strategies that have proven highly effective over multiple applications. Through the use of outside production and other third party resources, they plan to rapidly build their position, and consider marketing to be key to the new company’s success.
About the Company
PuraMed was established to capture two unique opportunities. The first is to build a substantial and profitable business, rapidly, beginning with three products developed by its founders: LipiGesic™ M (for acute relief of migraine headaches), LipiGesic™ H(for acute relief of tension headaches) and PuraMed™ PM (for insomnia). Each of these is effective and addresses a very large OTC consumer market, collectively well over $2 billion in the U.S. Each product will be unique in its class .