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How can we send a letter to the STOCK EXCHANGE COMISSION to ask for an investigation on this stock?
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm289601.htm
The information should be available for the public to review.
Lola Maksumova M.D., Ph.D. is a well documented scientist at the Departments of Pediatrics, Microbiology and Immunology, and Pathology and Laboratory Medicine, University of British Columbia. She is the Chief Operating officer and Senior Vice President at Kedem & I think that she may be able to turn this stock around. I have read her work & I believe that she sees the potential in this stock or she wouldn't be in this position. I don't understand why Dr. Salari resigned, but Kedem still has the patients on the sublinguals & Dr. Salari still holds much of the stock in the company. Perhaps we need to convince Pfizer to take an interest in this technology, which could make money for them and us.
All they need is to have the FDA approve the first clinical trial. The problem is the FDA. They ignore the little guys & cater to the big pharmaceuticals. If we could get Pfizer's attention, then it would change quickly & the FDA would approve the trial, since it would ultimately benefit Pfizer.
SEC Chairman Christopher Cox called naked short selling "a fraud that the commission is bound to prevent and to punish." In March 2008, SEC Chairman Christopher Cox gave a speech entitled the "'Naked' Short Selling Anti-Fraud Rule," in which he announced new SEC efforts to combat naked short selling.[33] Under the proposal, the SEC would create an antifraud rule targeting those who knowingly deceive brokers about having located securities before engaging in short sales, and who fail to deliver the securities by the delivery date. Cox said the proposal would address concerns about short-selling abuses, particularly in the market for small-cap stocks.
"Requests for clinical trial approval should ordinarily be made in writing, however, in limited circumstances, such requests may be made orally and permission may be given orally by the Director. Oral requests and approvals must be promptly followed by written requests and written approvals".
This is the proceedure for the FDA.
You need to copy paste the three trials from the KEDEM website, so the FDA will know what you are refering to. A phone call is OK, but they will do nothing without a written letter. I think that you should write them first & then call later, so they can reference your letter while talking with you.
The problem is that the FDA has been dragging its feet on approving the clinical trials. We need to contact them to speed up the process. They work much faster for the large pharmaceuticals. Here is the contact info. Be proffessinal in your responses.
301-796-8340
gcp.questions@fda.hhs.gov
Office of Good Clinical Practice
Food and Drug Administration
Office of Good Clinical Practice
Office of Special Medical Programs
10903 New Hampshire Ave., WO32-5103
Silver Spring, MD 20993
I completely agree. I invested $50,000 & I would never sell less than I paid for the stock. Patience is worth everything in medical stocks.
Forbes Magazine article on Dr. Salari
Hassan Salari is an entrepreneur and scientist. Dr. Salari has over 25 years? experience in the biotechnology field, specializing in highly sophisticated research and drug development programs and business development. Currently, Dr. Salari is the Chairman, President and Chief Executive Officer of Global Health Ventures Inc., now with a new name and stock symbol KDMP.OB, a company traded on the OTC Bulletin Board. Further, Dr. Salari is a director of Neurokine Pharmaceutical Inc , a company with an emphasis in neurological diseases. Prior to that, Dr. Salari was a director of Pacgen Biopharmaceuticals Inc., a public company with its shares listed on the TSX Venture Exchange. From 1998 to 2007, Dr. Salari was the chief executive officer and president of Chemokine Therapeutics Corp., a company established as a focused biotechnology company to develop chemokine-based therapeutic products for human diseases. Chemokine was a public company listed on OTC Bulletin Board and the TSX. From 1992 to 1998, Dr. Salari was the chief executive officer and president of Inflazyme Pharmaceuticals Ltd., a company founded by Dr. Salari. From 1991 to 1998, Dr. Salari was a Professor, Department of Medicine at the University of British Columbia. From 1987 to 1990, he was an Assistant Professor at the University of British Columbia. From 1986 to 1987, he was a research associate in the Department of Medicine at the University of British Columbia. He was the lead project investigator in cytokine research and drug development. From 1984 to 1986, he worked as a research associate at the Department of Physiology, Laval University. Dr. Salari carried out research work on the biology of human blood cells and their control by cytokines. From 1981 to 1982, Dr. Salari worked at the Department of Immunology at McGill University in Montreal as a research associate. He is the author of over 200 scientific articles, abstracts and books in various subjects of medicine.
I believe that you are right. We are ahead of everyone else. They will start buying as the value starts shooting up.
This is from Forbes magazine;
Hassan Salari is an entrepreneur and scientist. Dr. Salari has over 25 years? experience in the biotechnology field, specializing in highly sophisticated research and drug development programs and business development. Currently, Dr. Salari is the Chairman, President and Chief Executive Officer of Global Health Ventures Inc., now with a new name and stock symbol KDMP.OB, a company traded on the OTC Bulletin Board. Further, Dr. Salari is a director of Neurokine Pharmaceutical Inc , a company with an emphasis in neurological diseases. Prior to that, Dr. Salari was a director of Pacgen Biopharmaceuticals Inc., a public company with its shares listed on the TSX Venture Exchange. From 1998 to 2007, Dr. Salari was the chief executive officer and president of Chemokine Therapeutics Corp., a company established as a focused biotechnology company to develop chemokine-based therapeutic products for human diseases. Chemokine was a public company listed on OTC Bulletin Board and the TSX. From 1992 to 1998, Dr. Salari was the chief executive officer and president of Inflazyme Pharmaceuticals Ltd., a company founded by Dr. Salari. From 1991 to 1998, Dr. Salari was a Professor, Department of Medicine at the University of British Columbia. From 1987 to 1990, he was an Assistant Professor at the University of British Columbia. From 1986 to 1987, he was a research associate in the Department of Medicine at the University of British Columbia. He was the lead project investigator in cytokine research and drug development. From 1984 to 1986, he worked as a research associate at the Department of Physiology, Laval University. Dr. Salari carried out research work on the biology of human blood cells and their control by cytokines. From 1981 to 1982, Dr. Salari worked at the Department of Immunology at McGill University in Montreal as a research associate. He is the author of over 200 scientific articles, abstracts and books in various subjects of medicine.
As soon as any of these clinical trials are approved by the FDA. They take their merry time about approving trials, unless there is a big pharmaceutical to pressure them to hurry up.
Yes I am. I am in the same boat as you & came in at 5 cents, so $1 will break even. I believe that this stock will go much higher, so I'm not selling at $1, but I will ride it out until it peaks. When you see a double peak, then thats the time to sell.
I completly agree. I work with clinical trials every day & am working on a online Master of Science in "Regulatory Affairs for Drugs, Biologics, and Medical Devices" from Northeastern University. These are very good medications to give sublingually.
I do too. It's only a matter of time & the clinical trials will be approved. The only delay is the FDA, which gets around to approving trials at their leisure, so the delay is the FDA.
You are right. I am being patient, because I know that this will take off. I work with clinical trials & I see the stocks skyrocket, when the FDA approves the trials. Hang in there, things will change!
Gleevec or Imatinib is the first member of a new class of agents that act by specifically inhibiting a certain enzyme that is characteristic of a particular cancer cell for CML Leukemia, rather than non-specifically inhibiting and killing all rapidly dividing cells, this is a "targeted therapy" which kills only the cancer cells.
"Targeted Cancer Therapies" are the future of Oncology. My website shows these programs that will revolutionize Oncology and the Pharmaceutical Industry (the worlds largest industry).
My website; http://www.biologicalcancertreatments.com/
Dr. Salari is making some very intelligent moves. This stock will soar. It will be worth the wait!
They are in the Glass Tower.
http://www.residencesatgeorgia.com/
I have ST & they are great in trading.
"We have not generated any revenues from inception to May 31, 2009. We do not anticipate generating any revenues until we have developed our products to the point where they are suitable for commercial production" To date, we have had negative cash flows from operations and we have been dependent on sales of our equity securities and debt financing to meet our cash requirements. We expect this situation to continue for the foreseeable future. We anticipate that we will have negative cash flows during the next twelve month period ended May 31, 2010."
Great Video of X-Excite
While a security is undergoing reorganization, it will not be available for online trading. Such corporate actions can include name changes, symbol changes, mergers and forward or reverse splits.
We will post the new shares of GHLVD to your account once payment has been received from the depository or agent. We do not have an anticipated date of receiving the new shares at this time. Your patience is greatly appreciated.
This stock just jumped to $2.90 today from $.05. That is incredible.
The trial work is processing with Dr. Lola and the manufacturer, I do not know if the protocol was submitted to FDA yet or not and it will have to be approved from the FDA once submitted to start the trial.
Dr Salari has told me to still expect in 4th qtr – Kelly
The trial work is processing with Dr. Lola and the manufacturer, I do not know if the protocol was submitted to FDA yet or not and it will have to be approved from the FDA once submitted to start the trial.
Dr Salari has told me to still expect in 4th qtr – Kelly
We are currently working on the protocol that will be required for submission to the FDA. The company will issue a press release when this is submitted if they are allowed. I am not sure you can announce the FDA submission.
This all part of the process that the company hired Dr Lola to communicate with manufacturing and FDA submission.
Regards, Kelly
Jensemann, could you write Dr Salari & ask him why he doesn't have the upcoming Clinical Trial listed on "Clinical Trials.gov" all clinical trials are usually listed there? I didn't even find the one in the EU listed.
As Generics Near, Makers Tweak Erectile Drugs
By DUFF WILSON
Published: April 13, 2011
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Facing generic competition for its “little blue pill,” Pfizer recently started selling a chewable form of Viagra in Mexico. It is called Viagra Jet, and Pfizer says it may also market it to other nations in the developing world, if not the United States.
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Cialis is projected to become the top-selling of the three drugs in the world this year, passing Viagra.
Levitra, another erectile dysfunction drug, is now sold as a dissolvable tablet in nine European countries and may come to American pharmacies as soon as this month under the name Staxyn. That new form of the drug, which fizzes and dissolves in seconds, is marketed in a pocket-size, midnight-black box for men who prefer to take it discreetly, without water.
The third drug for erectile dysfunction to reach the market, Cialis, now eight years old, is racing ahead of the others because of two ideas that have proven extremely popular: an everyday pill and a 36-hour “weekender.” Cialis is projected to become the top-selling of the three drugs in the world this year, passing Viagra.
The market for drugs to correct erectile dysfunction has passed $5 billion a year from sales to tens of millions of men. And it is increasingly being driven by novel applications to compete with the lower-priced generics on the horizon.
“ ‘Gimmick’ is a strong word, but all of this is designed to create new brand identities,” Dr. Joseph P. Alukal, an assistant professor and director of reproductive health at the New York University School of Medicine, said. “A newer product, less expensive, and a new form of taking it — all that might convince more people to try it.”
Research is also under way in Brazil on a faster-acting form of the drugs, which increase blood flow by relaxing smooth muscle cells. While the existing pills enter the bloodstream indirectly by way of the stomach, intestines and liver, this form would enter more directly, dissolving in a capillary-rich space under the tongue and increasing the blood flow within 10 or 15 minutes. The research in Brazil involves generic Viagra, but Pfizer says it is not sponsoring the work.
The Mexican experiment with Viagra Jet will show whether the chewable form of the drug has promise in other countries, particularly developing markets, Susan O’Connor, Pfizer’s vice president of global commercial development, said in an interview. Studies showed most Mexican men who used Viagra ground it up to make it easier to swallow or in the belief it would start acting faster.
In explaining why the drug is being test-marketed in Mexico, Ms. O’Connor cited “patient preference, found in market research.” Mexico is the biggest market for Viagra in the developing world, with about $55 million in sales last year. At this point, Pfizer does not have plans to bring Viagra Jet to the United States, she said.
In America, Pfizer is battling to keep low-price generic competition off the shelves a year from now, when the drug’s patent expires. The generic pills would cost only a fraction of the $10 or more that each pill now costs.
Bayer, meanwhile, has introduced the dissolvable form of its Levitra drug in Austria, France, Hungary, Germany, Spain, Poland, Sweden, Denmark and Britain, where it went on sale in late March. The drug is called Levitra ODT, for orodispersible tablets. It comes in a thin black package the size of a half-dozen stacked credit cards, with four pills on a card that slides out.
“It’s pocket-friendly, discreet and gives the product a playful edge over its competitors,” Thomas Proske, global brand manager for Levitra at Bayer Healthcare, said in a statement.
The same pill was approved in the United States last June under the brand name Staxyn.
It will be available in pharmacies this month, according to Jess Macnaught, marketing executive with Burgopak Design and Packaging, the London company that designed the new black package. GlaxoSmithKline and Merck have licensed American rights from Bayer, but they declined to reveal when the drug would be introduced. Last year, they said Staxyn would reach the market in late 2010.
Worldwide sales of erectile dysfunction drugs grew 6.9 percent in 2010, to about $5 billion, and 4.7 percent in 2009, according to the industry data firm IMS Health.
Dr. Alukal of New York University said he thought Staxyn could be sold for a much lower price than what Levitra and other pills now cost, in part to compete with a generic Viagra. No price has been revealed.
“I guess it could be easier to ingest, so it could expand its market somewhat, but in the end the bigger issue would be cost,” Dr. Alukal said. He said the companies, for whom he does not consult, had talked about lower pricing, perhaps to under $10 a pill.
But for now, Pfizer, the company that started it all, is focusing its attention on protecting the pricing power and brand integrity of Viagra.
Patrick Ford, a former F.B.I. agent who leads the company’s security operations in the Americas, says Viagra is the most counterfeited product in the world. His agents pose as buyers, collect evidence and bring fraud cases to prosecutors, and he says fake Viagra may be unsafe. Pfizer and other pharmaceutical companies are working with Victoria Angelica Espinel, the government’s intellectual property enforcement coordinator, a position President Obama appointed her to in 2009.
Pfizer is also using its legal firepower against would-be generic competitors. Pfizer has two patents for Viagra, one for its chemical, expiring in 2012, and the other for its use against impotence, expiring in 2019. Pfizer sued Teva Pharmaceutical Industries, the biggest generic-drug company, in March 2010 under the “use” patent. The suit is pending in a Virginia federal court.
MacKay Jimeson, a Pfizer spokesman, said the company was confident it would keep the 2019 patent protection, but industry analysts disagree.
“ ‘Use’ patents are not highly probable of being upheld in court,” said C. Anthony Butler, a Barclays Capital pharmaceuticals analyst. “Most if not all analysts assume the expiry of the drug upon expiry of the composition of matter patent.”
The chemical patent expires on March 27, 2012. Pfizer may be able to extend it another six months, to September 2012, under a federal law called the Best Pharmaceuticals for Children Act. The law is meant to encourage drug companies to study children’s uses, often a difficult and unprofitable area.
In this case, what would be studied is not Viagra for children, but Revatio, a formulation of the same chemical, sildenafil, which is approved for pulmonary arterial hypertension, a rare and dangerous condition affecting hundreds of children in the United States. Mr. Jimeson said the company was working closely with the Food and Drug Administration to discuss the pediatric studies of Revatio and the potential for an extension on the chemical patent, which would also protect Viagra and its prices.
Many men, though, have waited years for a lower-priced Viagra and their wish may come true next year.
Other researchers are testing new uses for Viagra that Pfizer says it is not financing. Boston University is studying it with testosterone gel in men 40 to 70. Laboratório Teuto Brasileiro, in Brazil, where the patent expired last year, has filed a notice of intent to test it in a tablet that dissolves under the tongue and has an effect in 10 minutes or so. Pfizer owns 40 percent of the lab but says that it did not initiate the study.
Eli Lilly, meanwhile, says it has no plans to try chewable or dissolvable or any other forms of its Cialis tablets, and why should it? Cialis sales have steadily increased since it was introduced in 2003, to $1.7 billion last year, close to Viagra’s $1.9 billion. The health care investment house Leerink Swann estimates that Cialis sales will edge past Viagra in 2011 and far surpass the iconic blue pill in 2012.
Shawn Heffern, Lilly’s United States marketing director for Cialis, says, “I couldn’t be more happy.”
A version of this article appeared in print on April 14, 2011, on page B1 of the New York edition.
Because any pharmacist can compound sublingual Viagra legally. To market it is a different story because of the patent rights. It would be a good question for Dr Salari to answer.
Dr Salari definitely has their attention from his trial in europe & he holds the patent, so they will have to approach him for the patient rights after the trials
It's Pfizer doing the clinical trial in Brazil.
Pfizer is very interested in the sublingual Viagra!
Teuto and Pfizer close unpublished partnership
A great partnership was announced last Wednesday, October 21st, in Sao Paulo. Pfizer the American company and Laboratorio Teuto Brasileiro S/A announced a partnership where the multinational now holds 40% of the Brazilian industry. The focus of such deal is the generic medicine production.
The deal had a worldwide repercussion and it valued the value of Pfizer´s shares in the New York´s Stock market. In the economy editorials of the Brazilian newspapers the issue was the entrance of Pfizer into the generic medicine Brazilian market. Laboratorio Teuto, pioneer in the generic production in Brazil, occupies the third place (in units) in the ranking of pharmaceutical companies that produce generics in the country.
The deal was closed with R$400 million reais and it may represent a much larger figure considering the technological advances and the benefits on the population that may come up with this partnership. At first Teuto will be able to distribute Pfizer´s medicines in its sales points and vice versa.
The agreement will also allow a second instance where Teuto will launch its generic medicine as well as Pfizer generics, and the American company will be able to produce Teuto´s products. The partnership between both companies is also an alignment commercially speaking, since Laboratorio Teuto serves more than 36 thousand independent pharmacies and Pfizer has a great commercial partnership with the largest networks and also within the largest centers.
Present in Brazil for over 60 years, Pfizer closed such partnership with Teuto for being a company of great potential in Brazil, Teuto which has a solid history and continuous growth. Moreover, the company has an excellent industrial park, operation, distribution network, quality and portfolio, composed by generic medicine, prescription exempted (OTCs) and similars, with more than 400 presentations.
“For Teuto such partnership with Pfizer is of great importance for our business objectives. We will expand our product portfolio to meet the patients and market demands,” Marcelo Henriques comments, Teuto President. The partnership also means development for the State of Goias with more business opportunities and Jobs.
Teuto Generics – Nowadays Teuto has the main active principles (API) commercialized and it is one of the sales championships in the pharmacies from all over the country. It has been establishing as one of the main players within such market. Laboratorio Teuto invests 7% of its revenue on Research and Development with the objective of strengthening even more the generic line and new drugs, it also has partnerships with universities and research centers all over the world t offer an updated and aligned portfolio with the market needs.
Laboratorio Teuto´s forecast is that over the upcoming years, with the product patent fall there will be a great volume sale, this market may gain muscle, increasing substantially its share in the market, reaching a total of 35% of the pharmaceutical medicine overall. Such increase is defined by ANIVISA (National Agency of Sanitary Surveillance). According to Dirceu Raposo, ANVISA President, it is necessary a larger disclosure coming from the laboratories themselves and that doctors and hospitals guide the patients about any of both medicines, generic or reference, since both can meet the treatment needs.
Here is a clinical trial starting in Brazil.
A Study to Evaluate a Possible Superiority Expressed by the Faster Onset of Action and the Efficacy and Safety of Sildenafil Citrate 20mg Sublingual Tablet in the Treatment of Erectile Dysfunction of Different Etiologies
This study is not yet open for participant recruitment.
Verified on March 2011 by Laboratório Teuto Brasileiro S/A
First Received on March 15, 2011. Last Updated on March 22, 2011 History of Changes
Sponsor:
Laboratório Teuto Brasileiro S/A
Information provided by:
Laboratório Teuto Brasileiro S/A
ClinicalTrials.gov Identifier:
NCT01321489
Purpose
The purpose of this study is to evaluate the tolerability and safety of Sildenafil Citrate 20mg Sublingual tablet, as well as a possible superiority expressed by the faster onset of action compared to Viagra ® 50mg tablet Coated in erectile dysfunction.
Condition
Intervention
Phase
Erectile Dysfunction
Drug: Sildenafil Citrate 20mg Tablet Sublingual
Drug: Viagra ® 50mg tablet Coated
Phase III
Study Type:
Interventional
Study Design:
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title:
A Clinical Phase III, Comparative, Open, Multicenter, Prospectively, to Evaluate a Possible Superiority Expressed by the Faster Onset of Action and the Efficacy and Safety of Sildenafil Citrate 20mg Sublingual Tablet, Compared to Viagra ® 50mg Tablet Coated, in the Treatment of Erectile Dysfunction of Different Etiologies
Resource links provided by NLM:
MedlinePlus related topics: Erectile Dysfunction
Drug Information available for: Citric acidSildenafilSildenafil citrateSodium Citrate
U.S. FDA Resources
Further study details as provided by Laboratório Teuto Brasileiro S/A:
Primary Outcome Measures: •Evaluate a possible superiority expressed by the faster onset of action. [ Time Frame: 35 days ] [ Designated as safety issue: Yes ]
To evaluate a possible superiority expressed by the faster onset of action of Sildenafil Citrate 20mg Tablet Sublingual compared to Viagra ® 50mg tablet Coated in erectile dysfunction.
Secondary Outcome Measures: •Evaluate the efficacy and tolerability of Sildenafil Citrate 20mg Sublingual tablet, compared to Viagra ® 50mg tablet Coated in control of Erectile Dysfunction. [ Time Frame: 35 days ] [ Designated as safety issue: Yes ]
The secondary outcame measure will be to evaluate the efficacy and tolerability of Sildenafil Citrate 20mg Sublingual tablet, compared to Viagra ® 50mg tablet Coated in patients with Erectile Dysfunction.
Estimated Enrollment:
78
Study Start Date:
September 2011
Estimated Study Completion Date:
January 2012
Estimated Primary Completion Date:
January 2012 (Final data collection date for primary outcome measure)
Arms
Assigned Interventions
Sildenafil Citrate 20mg Tablet Sublingual: Experimental
Administer one tablet of Sildenafil Citrate 20 mg sublingually 10 minutes before intercourse. It is recommended that the administration of just one tablet a day. The patient will receive six tablets of the medication.
Intervention: Drug: Viagra ® 50mg tablet Coated
Drug: Viagra ® 50mg tablet Coated
Administer one tablet of Viagra ® 50mg tablet Coated orally 1 hour before intercourse. It is recommended that the administration of just one tablet a day. The patient will receive six tablets of the medication.
Viagra ® 50mg tablet Coated: Active Comparator
Administer one tablet of Viagra ® 50mg tablet Coated orally 1 hour before intercourse. It is recommended that the administration of just one tablet a day. The patient will receive six tablets of the medication.
Intervention: Drug: Sildenafil Citrate 20mg Tablet Sublingual
Drug: Sildenafil Citrate 20mg Tablet Sublingual
Administer one tablet of Sildenafil Citrate 20 mg sublingually 10 minutes before intercourse. It is recommended that the administration of just one tablet a day. The patient will receive six tablets of the medication.
Detailed Description:
Phase III clinical trial, comparative, open, multicenter, prospectively, with random inflow of 78 patients evaluable male patients with erectile dysfunction with IIEF-5 score in between 13 and 24, corresponding to mild or mild to moderate to evaluate the efficacy and safety as well as a possible superiority expressed by the faster onset of action onset of action of study medication.
Eligibility
Ages Eligible for Study:
18 Years and older
Genders Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Criteria
Inclusion Criteria:
•Patients over 18 years;
•Patients with erectile dysfunction of various etiologies (organic, psychogenic and mixed) for at least 6 months;
•Patients with scores in the IIEF-5 between 13 and 24, which correspond to mild or mild to moderate;
•Relationship stable for at least 6 months;
•Patients should be kept with libido;
•Education at least 4 years;
•Do not use sildenafil, vardenafil, tadalafil, lodenafil, injection therapy or vacuum devices up to 72 hours before the screening visit;
•Functions hepatic, hematological, hormonal and renal within the following benchmarks:
•Creatinine: 0.6 to 1.10 mg / dl;
•Urea: 10 - 50mg/dl;
•TGP: up to 40 U / L;
•TGO: = 34 U / L;
•Prolactin: 2.3 to 11.5 ng / ml Men
•Total Testosterone: 241 to 827 ng/100 ml - Men
•Blood glucose: 70 mg / dl and 99mg/dl.
Exclusion Criteria:
•Patients who have failed treatment with inhibitors of phospho-diesterase inhibitors;
•Patients undergoing radical prostatectomy;
•Patients with hypersensitivity to any component of the formula;
•Presence of genital deformities or other disorders that prevent intercourse;
•Operations prior to penile erectile dysfunction or premature ejaculation penis enlargement;
•Use of other treatments for erectile dysfunction or concomitant treatment with nitrates;
•Myocardial infarction or cerebrovascular accident (CVA) for less than 6 months;
•Heart disease or uncontrolled serious;
•Injury cord injury;
•Multiple sclerosis;
•Retinitis pigmentosa;
•Neoplasms known in business and / or treatment;
•History of severe anaphylactic reactions and disease Steven-Johnson;
•Participation in a clinical study in the 2 months prior to inclusion;
•Patients who are making use of antiretrovirals;
•Any other disease or condition is not matched that in the opinion of the investigator, could lead to increased risk for the patient or who makes it inappropriate for this study;
•Comorbidities such as diabetes mellitus, malignant hypertension, blood pressure (BP), systolic> 170 mmHg, diastolic BP levels> 110 mmHg, blood pressure <80 x 50 mmHg, significant cardiovascular disease, alcohol or drugs, or other disorders important.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01321489
Contacts
Contact: Sidney Glina, Investigator
55 (11) 2069-9629
urohi@uol.com.br
Contact: Bluette Sandila, Coordenator
55 (11) 2069-9629
bluette.urohi@uol.com.br
Locations
Brazil
Ipiranga Hospital
Sao Paulo, Brazil, 04262-000
Sponsors and Collaborators
Laboratório Teuto Brasileiro S/A
Investigators
Principal Investigator:
Eduardo Bertero, Investigator
Hospital for State Civil Servants of Sao Paulo
More Information
No publications provided
Responsible Party:
Laboratório Teuto Brasileiro S/A, Industry
ClinicalTrials.gov Identifier:
NCT01321489 History of Changes
Other Study ID Numbers:
TEU-SIL-05/09
Study First Received:
March 15, 2011
Last Updated:
March 22, 2011
Health Authority:
Brazil: National Health Surveillance Agency
This stock will rise when the USA clinical trial begins in October & it will rise even more when the results of the six week trial is announced in December, which should be almost identical to the results in Europe. Hang in there & you will be in the green.
Hang in there Softball Daddy,
Wednesday's stock market dive would make anyone want to hit the panic button.
But it's important to understand why the markets have been swinging wildly in recent days — and what you should be doing to safeguard your nest egg.
We asked the experts to weigh in:
Q. Why are we seeing huge gyrations on a daily basis?
A. The markets are reacting to news in a very strong way because of all the uncertainty in the world.
"There is a lot of tension out there," said Uri Landesman, president of Platinum Partners, a New York hedge fund. "The world is highly charged right now."
Fear of a global economic slowdown and debt defaults in Europe has traders pulling the trigger when they see a negative headline.
"It's a 'sell first, ask later' mentality," said Ryan Detrick, senior technical analyst at Schaeffer's Investment Research.
Q. Why is what's happening in Europe impacting our stock markets?
A. Think of the global economy as an enormous web. U.S. banks hold European debt. As the European debt crisis grows, that could significantly impact our banks and the overall U.S. economy.
Q. Should we expect these kinds of wild ups and downs to continue?
A. Absolutely. "Until the uncertainty is lifted, volatility is here to stay," Detrick said.
Q. How do recent stock market gyrations compare with 2008?
A. So far, they pale in comparison.
From October through the end of 2008, there were 21 days of plus or minus around 4% moves on the Dow, said Jeffrey Hirsch, editor of the Stock Trader's Almanac.
"There was a lot more red then, than there is right now," he added.
Q. How does today's financial turmoil compare with the financial meltdown of 2008?
A. "The situation was much worse in 2008," Landesman said. "You had major financial institutions failing."
And unlike 2008, U.S. companies today are rich with cash on their balance sheets and banks are not holding nearly as much risky, highly-leveraged investments, Detrick said.
Q. What are the chances we are heading into another recession?
A. The chances of the country falling back into a recession are one in four, according to Reuters' monthly survey of 70 economists.
Q. What should I be doing to safeguard my 401(k)?
A. The key is to stay diversified, with a mix of stocks, bonds and cash. Don't bail out of stocks. Take a look first at when you will be needing your money.
"If your time horizon is at least five years, then you should have about 20% to 50% of your allocation in stocks," said Charles Failla of Sovereign Financial.
"If your horizon is less then five years and your exposure to stocks is greater than 50%, you will want to consider reducing your risk and exposure to stocks."
pfurman@nydailynews.com
Share .
HERE IS WHY GHLV WILL SEE DOLLARS......
Chairman and CEO, Dr. Hassan Salari is very well known in medical circles. He's the author of over 200 scientific books, journal articles, and abstracts, and is the owner of more than 50 patents. More importantly, Hassan has over 20 years experience in managing private and publicly traded pharmaceutical companies and has raised more than $70 million in funding for his companies.
GHLV could revolutionize the entire pharmaceutical industry:
This tiny company has beat Big Pharma to the punch and locked-up world-wide rights to a proprietary drug delivery platform that dramatically improves how medication is absorbed by the body. Simply put, this technology has the potential to make pill-form medication completely obsolete... and only GHLV has access to it.
Global Health (GHLV) is about to take three multi-billion markets by storm:
The company has a pipeline of drugs in lucrative, high-profile markets... new drugs that combat obesity, fight addiction, and battle erectile dysfunction. The combined revenues for these industries exceed $10 billion annually.
Global Health (GHLV) could get taken out for BILLIONS:
Think Big Pharma is going to stand by while GHLV takes their drugs, makes them better, and then sells them for cheaper? Not a chance. They'll gobble up GHLV and give shareholders a massive payday in the process.
GHLV is relatively low-risk:
Unlike other tiny biotechs where you're basically gambling on FDA approval, Global Health (GHLV) minimizes your risk by taking established drugs and making them better.
$4.3 Trillion All But Guarantees...
Healthcare and Biotech Will Be the Greatest
Bull-Market of the 21st Century
Healthcare is the largest industry in the United States. It accounts for 16% of GDP - more than anything else except defense spending.
Over the next few years, 77 million American Baby Boomers are set to retire. As they rush into old age en masse, biotech and health care spending is going to skyrocket.
The Department of Health predicts that by 2017 the amount of money spent on health care will hit a mind-boggling... $4.3 TRILLION PER YEAR.
That's more than the entire economic output of Germany,
Russia, Canada, and Australia... combined.
GHLV is a WIN/WIN situation...
No matter what the outcome is...
On June 16, 2011, Global Health Ventures Inc. (the "Company") entered into a private transaction with one investor (the "Investor"), pursuant to which the Company issued a secured convertible promissory note to the Investor in the amount of $4,338,833 (the "Note") with a 25% original issue discount in exchange for $3,250,000, consisting of $250,000 paid in cash and 12 secured convertible promissory notes in the amount of $250,000 each (the "Investor Notes"). The Note matures in 48 months, bears interest at a rate of 6% per annum and may be prepaid by the Company in whole or in part upon five trading days' written notice to the Investor so long as no event of default has occurred and the Company has a sufficient number of shares of its common stock authorized to accommodate conversion of the Note's outstanding balance. Upon the occurrence of an event of default, the outstanding balance of the Note will accrue interest at the rate of 12% per annum compounding daily.
The Note is secured by a security agreement between the Company and the Investor listing each of the Investor Notes as security for the Company's obligations under the various transaction documents. The Investor Notes each mature in 50 months, bear interest at the rate of 5% per annum, are pre-payable by the Investor at any time prior to their respective maturity dates and are secured by an irrevocable standby letter of credit subject to the terms and conditions of a Letter of Credit Agreement between the Company and the Investor. When issued, the Letter of Credit will be held in escrow in accordance with the terms of an escrow agreement between the Company, the Investor and an escrow agent (the "Escrow Agent").
The Investor has the right to convert the outstanding balance of the Note, in whole or in part, into shares of the Company's common stock in tranches consisting of the initial tranche and 12 subsequent tranches corresponding to the Investor Notes. The right of the Investor to convert any of the subsequent tranches is conditional upon the Investor paying to the Company the Investor Note corresponding to such tranche. The shares of the Company's common stock into which the outstanding balance of the Note, or the applicable portion thereof, is converted will be valued at the Market Price (as defined in the Note) at the time of such conversion.
As part of this financing, the Investor also acquired warrants to purchase shares of the Company's common stock equal to $250,000 divided by 100% of the average of the three lowest closing bid prices of the common stock reported by Bloomberg LP during the 20 trading days preceding June 16, 2011, exercisable until June 30, 2016. The warrants are evidenced by a warrant in the form attached hereto as Exhibit 10.3 (the "Warrant"), which contains full ratchet anti-dilution provisions as to the exercise price for the full term of the Warrant. In the event the Investor decides to effect a cashless exercise of the Warrant, or any portion thereof, the Investor is entitled to receive the number of shares of the Company's common stock equal to the excess of the current market value of such stock over the aggregate exercise price of the portion then being exercised, divided by the adjusted price of the common stock. The terms "current market value", "exercise price" and "adjusted price of the common stock" are each defined in the Warrant.
The Company issued the Note and the Warrant to the Investor in reliance upon the exemption from registration provided by Rule 506 of Regulation D ("Regulation D") promulgated under the Securities Act of 1933, as amended (the "Securities Act"). The Company's reliance on Rule 506 of Regulation D was based on the fact that the sale of the shares did not involve a "public offering", as defined in
Section 4(2) of the Securities Act, due to the number of investors and the manner of the offering.
The foregoing description of the Note, the Warrant and the Investor Notes is not intended to be complete and is qualified in its entirety by the complete text of the form of the agreements attached as exhibits to this current report on Form 8-K.
On June 15, 2011, the Company entered into a debt conversion agreement with Hassan Salari, its President, Chief Executive Officer, Secretary, Treasurer and director, pursuant to which Dr. Salari converted $54,000 worth of debt into 1,800,000 shares of the Company's Series "A" Preferred Stock at a price of $0.03 per share. The Company issued the 1,800,000 shares in reliance upon the exemption from registration provided by Rule 903 of Regulation S under the Securities Act ("Regulation S").
The Company's reliance on Rule 903 of Regulation S was based on the fact that the shares were sold in an "offshore transaction", as defined in Rule 902(h) of Regulation S. The Company did not engage in any directed selling efforts in the United States in connection with the sale of the shares, and Dr. Salari is not a U.S. person and did not acquire the shares for the account or benefit of any U.S. person.
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Item 5.03 Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year
On June 15, 2011, the Company filed a Certificate of Designation with the Nevada Secretary of State to designate 10,000,000 shares of the Company's authorized but unissued preferred stock as Series "A" Preferred Stock.
On June 16, 2011, the holders of a majority of the Company's issued and outstanding stock approved an amendment to the Company's bylaws (the "Bylaw Amendment") and an increase in the Company's authorized capital from 196,000,000 shares of common stock, par value $0.0001, to 1,000,000,000 shares of common stock, par value $0.0001 (the "Authorized Capital Increase"). The number of shares of preferred stock the Company is authorized to issue did not change as a result of the Authorized Capital Increase.
The purpose of the Bylaw Amendment was to update the Company's bylaws and make them more comprehensive, while the purpose of the Authorized Capital Increase was to reorganize the capital structure of the Company in connection with the financing described in Items 1.01 and 3.02 above.
The Company formally effected the Bylaw Amendment on June 16, 2011 and the Authorized Capital Increase on June 17, 2011 by filing a Certificate of Amendment with the Nevada Secretary of State.
On April 27:
They have endorsed the work with Omnicare of Philadelphia on the details of the clinical trials.
On the June 2:
They announced that the company has signed a contract with a FDA approved, GMP licensed phamaceutical manufacturing company, Confab, for the production of X-Excite.
On the June 22:
The company announced that it has completed the clinical trials, a PK study in Europe under EMEA guide line. The company reported details of the trial, and it said the trial provided the expected and successful end point.
On the July 6:
They announced it has appointed Dr. Lola Maksumova,MD,PhD as senior VP and Chief Operating Officer mainly for the third party contract research organization and FDA.
On the July 16:
They announced that they have secured finance for the projects.
This stock will soar. Buy it while you can at this price.
Doc is right this stock is going to explode. With this kind of results, it will rise sharply when it gains enough attention.
press release
June 22, 2011, 9:17 a.m. EDT
Global Health Ventures Completes European Clinical Trials Phase I for X-Excite vs. Viagra(R)
VANCOUVER, British Columbia, Jun 22, 2011 (GlobeNewswire via COMTEX) -- Global Health Ventures Inc. /quotes/zigman/529382 GHLV +2.86% , a specialty pharmaceutical company with focus on sublingual drug delivery is pleased to announce that it has completed the clinical trials, a pharmacokinetics (PK) study in Europe under EMEA guideline and the final report has been obtained.
In the study, 12 subjects were given 25 mg sildenafil base from Pfizer, oral formulation known as Viagra(R) and another 12 subjects were given 25 mg sildenafil citrate (20.6 mg X-Excite). Blood was taken from each tested subject at 1, 15, 20, 30 and 45 minutes and then 1, 2, 3, 5, 8, and 12 hours. The plasma samples were analyzed for sildenafil concentration with a method that has a lower limit of quantification (LLOQ) of 2 ng/ml. The primary objective was the blood pharmacokinetic analysis, maximal drug concentration and time from administration to maximal concentration in plasma (Cmax and Tmax), as well as area under plasma time/concentration curve from 0 to 8 hours of sildenafil (AUC).
The results in summary, showed, X-Excite to appear in the blood significantly faster than Viagra(R), stay in the blood longer, and based on actual sildenafil drug used, have a greater AUC. Furthermore, none of the subjects which received X-Excite, dropped out of trials nor any complications were observed. The trials provided the expected and successful end point.
"We are very pleased with the completion of our European trials and now we are proceeding with the clinical trials in the United States under the FDA guideline. First step in the U.S. trial, is to produce the drug in an FDA approved GMP facility. We have already started the process of manufacturing of our drug for U.S. clinical trials," said Dr. Hassan Salari, Chairman and CEO of Global Health Ventures Inc.