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Time left in your bet ... and for Cobalis to deliver on time (well for this month)
http://www.7is7.com/otto/countdown.html?year=2007&month=6&date=1&hrs=0&min=0&sec...
I hope they make it!!! (Sorry Mike, nothing personal)
Seven days left in May. And even fewer trading days.
At this point, it is a management issue for me. (competence and trust issues) If they miss a second deadline, I will lose some of both.
Lets see if they can earn these salaries... http://finance.yahoo.com/q/pr?s=CLSC.OB
Witness!
If the phase 3 results are released before midnight 5/31/07, then Randy wins.
But if the results are released after that (or if there is a news release explaining another delay), then dolphinsmike wins.
The prize:
2 bottles of BARTENURA Moscato D'Asti
Is that correct?
Beach... don't blame the board if you are not happy with the bet you negociated. You just need to make a better bet next time. Like going for the whole bottle of Tequila and not just one Margarita.
Well, just under 2 weeks left in May. I hope dolphinsmike is wrong and we get news before month's end.(No offense Mike).
As for me, I am going to grab a beer and try to enjoy the weekend.
I voted for today. So it doesn't look good for me.
But the day is not over yet...
http://www.investorshub.com/boards/read_msg.asp?message_id=19603232
My prediction is $3.56 for price and 5/18 for the date.
This article is from South Florida Business Journal - August 4, 2005
Old News.
http://www.cobalis.com/news/news_21.pdf
Here are the the first Phase 3 results. This was a smaller trail of 714 patients.
Randy,
I agree that the timing is good concerning the bad allergy season this year.
But I expected to see more movement in the stock in anticipation of good results. Perhaps I am jumping the gun a bit here.
In any case, we will see fast movement either up or down soon enough.
So I am keeping my fingers crossed for POSITIVE results.
Good luck to us all.
ScaryStocks
The South has the sniffles from pollen
By MEG KINNARD, Associated Press Writer Tue Mar 27, 6:41 PM ET
COLUMBIA, S.C. - A yellow haze of pollen descended on the Southeast in the past week, coating cars and porch furniture and making people miserable in one of the worst allergy seasons in years. Doctors are telling people with stuffed-up noses and itchy, watery eyes to spend more time indoors if they can.
"Everybody who walks through the door, you can see it in their faces," said Atlanta pharmacy owner Ira Katz, who is running low on medication to treat what he said is the worst allergy season of his 26 years in the business.
Atlanta's pollen count hit 5,499 particles per cubic meter of air Monday, the highest so far this season and the fourth highest in the 12 years that the Atlanta Allergy and Asthma Clinic has been keeping records. In South Carolina, the pollen count hit 4,862, according to the Allergic Disease and Asthma Center in Greenville.
A reading of 120 is considered extremely high in the Southeast.
A lack of rain is blamed for the high pollen count. Rain scrubs pollen from the air.
The yellow dust — which is coming mostly from pine trees — is proving to be a gold mine for car washes, even though some are offering free repeat washes for cars that get covered again within 48 hours.
"Business has been good, very good," said Steve Bell, assistant manager of Al's Car Wash & Detail Shop in West Columbia.
Waiters at restaurants with outdoor seating spend their time between meals wiping down the furniture.
Atlanta has had only four rainy days this month. Most of the rain Columbia has gotten came during the first part of the month, before the pollen arrived.
"Unless we get some rain, people could be having symptoms for quite some time," said Dr. Stanley Fineman, at the Atlanta allergy clinic.
Relief might be days away. There is no rain in Atlanta's forecast for at least a week.
Experts recommended allergy sufferers keep their outdoor activities to a minimum in the early morning, when pollen is at its worst.
Dr. Lisa Hutto, an allergy specialist, said wearing a mask when doing yard work and changing clothes and showering right away after coming inside can also help. And though it may be tempting, Hutto said people should not hose off porches or cars.
"Washing the pollen off could cause it to become airborne, and you could have more exposure," she said. "Even if you hose off your porch or car, it's just going to come back."
___
Form 8-K for COBALIS CORP
1-Mar-2007
Amendments to Articles of Inc. or Bylaws; Change in Fiscal Year, Other Events
ITEM 5.03 Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year.
On March 1, 2007, Cobalis Corp., a Nevada corporation (the "Registrant") submitted an amendment to its Articles of Incorporation for filing with the Secretary of State of Nevada to effectuate an increase in its authorized stock to 100,000,000 shares of common stock. That certificate of amendment is attached hereto as Exhibit 3.1.
ITEM 8.01 Other Events.
The amendment was approved by a vote of security holders at the Registrant's special meeting of shareholders held on March 1, 2007. The votes were as follows: 20,609,126 votes were cast for approving the amendment, or 57.8% of the total issued and outstanding as of the record date; 254,398 votes were cast against approving the amendment, or 0.7% of the issued and outstanding; 10,589 votes abstained, or less than 0.1%; and there were 7,935,589 broker non-votes. Reference is made to the Registrant's proxy statement on Schedule 14A filed on or about February 9, 2007.
ITEM 9.01 Exhibits
Number Description
3.1.3 Certificate of Amendment to Articles of Incorporation
Now all we can do is wait.
http://www.investorshub.com/boards/read_msg.asp?message_id=12912138
Good luck to all.
Beach,
Thanks for the follow up. Good point on the 70 sites and how that will help normalize the data if 1 or 2 sites have low pollen.
I was thinking along the lines of Aimimg4's point earlier this year. That is why I was putting the pollen map from weather.com up on this board from week to week during the trials. It was clear to me that there were some areas this past year that had very low pollen count.
But I think your point is valid, the large number of sites should help reduce this effect.
ScaryStocks.
Cobalis Announces Second Closing in $3.85 Million Funding
Thursday February 22, 6:36 am ET
IRVINE, Calif.--(BUSINESS WIRE)--Cobalis Corp. (OTC BB: CLSC - News) a pharmaceutical development company specializing in anti-allergy medications, announced today that it has received its Second Closing of $675,000 in accordance with the terms of its Security Purchase Agreement dated December 20, 2006.
As previously announced, a $2.5 million debenture was issued at the First Closing on December 20, 2006. Pursuant to the Security Purchase Agreement, the Second Closing was to occur with the filing of a Registration Statement for shares underlying the $3.85 million funding. The final and Third Closing of $675,000 shall be funded within three business days after the Company's related Registration Statement is declared effective by the United States Securities and Exchange Commission, provided Cobalis shareholders have approved an increase in authorized Cobalis' shares.
Cobalis intends to use the proceeds of its Second Closing to complete data collection and analysis, and to report top-line efficacy results from its ten-week twin Phase III Clinical Trials for its anti-allergy medication, PreHistin(TM). The 1,551 patient randomized, double blind, placebo-controlled trials completed patient dosing in October 2006. The trials were designed to test the safety and efficacy of pre-seasonal treatment with PreHistin on moderate to moderately severe seasonal ragweed allergy patients.
About Cobalis Corp.
Cobalis Corp. is a specialty pharmaceutical development company specializing in medications to prevent and treat atopic disease, including allergies, migraine headache, atopic asthma and dermatitis. Its flagship drug candidate PreHistin is an allergy prevention medication in Phase III clinical development. Cobalis plans to seek FDA approval to market PreHistin over-the-counter in the US. For further information, visit www.cobalis.com
Safe Harbor
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). Cobalis disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Safe Harbor for forward-looking statements contained in the Act. Examples of such statements include, but are not limited to, any statements relating to the timing, scope or expected outcome of the Company's clinical development of its drug candidates, the potential benefits of the Company's drug candidates and the size of the potential market for the Company's products. Such statements are based on management's current expectations, but actual results may differ materially due to various factors. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to securing funding for ongoing operations including clinical trials, difficulties or delays in development, testing, regulatory approval, production and marketing of the Company's drug candidates, unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug candidates that could slow or prevent product approval or market acceptance (including the risk that current and past results of clinical trials are not necessarily indicative of future results of clinical trials), the development of competing products by our competitors; uncertainties related to the Company's dependence on third parties and partners; and those risks described in our quarterly report on Form 10-QSB filed with the SEC on February 20, 2007.
Contact:
Jaffoni & Collins Incorporated
David Collins or Steven Hecht, 212-835-8500
CLSC@jcir.com
Source: Cobalis Corp.
Chocolate Milk Fuels Tour of CA
Sunday February 18, 3:05 pm ET
Good Old Fashioned Favorite Propels Cyclists Through Golden State
SAN CLEMENTE, Calif., Feb. 18 /PRNewswire/ -- The Tour de California is here! For the next eight days, some of the worlds' top cyclists will race to the finish line each day as part of the 2007 AMGEN Tour of California. And, according to sports nutritionists, the best drink to get the pros through this grueling 700-mile race is not a high-tech commercial sports concoction, but good old fashioned chocolate milk.
"Cyclists need incredible strength and endurance to compete in a race like this," stresses Christina Lazzaretto, a registered dietician and sports nutritionist with San Francisco-based MV Nutrition. "Chocolate milk naturally contains a unique combination of proteins and carbohydrates to help cyclists perform at peak levels and recover day after day."
Lazzaretto's recommendations echo a study in the International Journal of Sports Nutrition and Exercise Metabolism published last year. Indiana University researchers studied cyclists and found that when given chocolate milk 30 minutes after practice, they recovered better and more quickly when compared with other commercial sports beverages.
"In a sport where stamina is absolutely essential, the body needs the nutrients in chocolate milk," says Lazzaretto. "I recommend it to all my clients."
But it's not just pro cyclists that need milk, say the experts. Active adults and kids benefit too. Chocolate milk contains calcium, protein, and carbohydrates -- all in the right combination -- to provide the energy and nutrients essential to strengthen bone, rebuild muscle cell and recover quickly after a vigorous workout or play.
"Plus the good news is it doesn't cost a bundle," says Steve James, Executive Director of the California Milk Processor Board (CMPB). "And it's right there in your fridge."
As one of the fastest growing sports in the country, the 700-mile Amgen Tour of California bike race is expected to draw more than a million spectators. The race kicks-off February 18th in San Francisco and finishes February 25th in Long Beach.
Nutritionists recommend a cyclist (average weight 150lbs) should drink between two and three eight-ounce glasses of chocolate milk after training or competition.
AMGEN Tour of California
The AMGEN Tour of California brings professional bicycle racing to the California coast. The world's top professional teams will compete over an eight-day, 700-mile race on a route that includes the California redwoods, wine country and the Pacific Coast. This year, the initiative will support The Wellness Community and the National Coalition for Cancer Survivorship. For more information visit www.amgentourofcalifornia.com
The California Milk Processor Board was established in 1993 to make milk more competitive and increase milk consumption in California. GOT MILK? is a federally registered trademark that has been licensed by the national dairy boards since 1995. GOT MILK? gifts and recipes can be viewed at http://www.gotmilk.com. The CMPB is funded by all California milk processors and administered by the California Department of Food and Agriculture.
Source: California Milk Processor Board
CCE had a news today: Read the second to last sentence regarding expansion of product lines to "fast growing beverage groups". Speculation of an aquisition of BRVO may explain todays volume. Thoughts???
Coca-Cola Bottler to Ax About 3,500 Jobs
Tuesday February 13, 11:05 am ET
By Harry R. Weber, AP Business Writer
Coca-Cola Enterprises to Cut About 3,500 Jobs; Bottler Posts $1.7 Billion Loss in 4th Quarter
ATLANTA (AP) -- Coca-Cola Enterprises Inc., the biggest bottler of Coca-Cola beverages, said Tuesday it would cut about 3,500 jobs, or 4.7 percent of its work force, as it reported a whopping $1.7 billion loss in the fourth quarter.
The Atlanta-based company said it expects to report a corresponding charge of about $300 million, which will be booked in 2007 and 2008.
The move had been widely anticipated by analysts who said the company has struggled with higher costs for aluminum and other commodities and a shift in consumer tastes away from carbonated beverages to juices, teas and waters.
The company said the restructuring would "create a highly efficient supply chain and order fulfillment structure, and improve customer service by implementing new selling systems for many of our customers."
"Through this restructuring, we will enhance standardization and consistency in our operating structure and business practices," CCE said in a statement.
CCE currently has 74,000 employees, spokeswoman Laura Asman said.
The Coca-Cola Co., the world's largest beverage maker, is scheduled to report its fourth-quarter and year-end 2006 results on Wednesday. It owns a stake in CCE, which bottles Coca-Cola products and delivers them to market.
CCE's loss in the fourth quarter, which included a hefty franchise impairment charge, amounted to $3.59 a share, compared to a loss of $57 million, or 12 cents a share, for the same period a year ago.
Excluding one-time items, CCE said it earned $95 million, or 20 cents a share. On that basis, analysts surveyed by Thomson Financial were expecting earnings of 16 cents a share.
Revenue rose 6 percent in the fourth quarter to $4.79 billion, compared to revenue of $4.50 billion recorded in the same period a year ago.
For all of 2006, CCE said it lost $1.1 billion, or $2.41 a share, compared to a profit of $514 million, or $1.08 a share, for the same period a year ago. Twelve-month revenue rose to $19.80 billion, compared to $18.74 billion recorded in the same period a year ago.
Also Tuesday, Coca-Cola Enterprises announced strategic initiatives to expand its existing product portfolio "in fast growing beverage groups" and to make its distribution more efficient.
Its shares rose 29 cents, or 1.4 percent, to $20.82 in morning trading on the New York Stock Exchange.
Winter no relief for allergy sufferers
By REBECCA SANTANA, Associated Press Writer
TRENTON, N.J. - The unseasonably warm weather along the East Coast has flooded some offices with patients suffering from an unusual ailment this time of year: allergies.
Doctors say this winter's weather has sparked an onslaught of mold spores that cause allergies and fluctuating temperatures that irritate already-suffering nasal passages. Many patients may confuse an allergic reaction with a common cold.
"The phone is ringing off the hook — it's incredible," said Dr. Clifford W. Bassett, vice-president of the American Academy of Allergy, Asthma and Immunology, who has a practice in Manhattan.
"It's an explosion of people who are realizing that they may have allergies," said Bassett. "Typically, January and February are quiet times in most allergists' offices."
Mold spores that grow outdoors would normally die off during a cold snap or be covered with snow. But in warm weather mold spores continue to grow and spread. Throwing open the windows to enjoy the weather makes things worse: The mold spores waltz inside.
Maria Carola, 35, of New York said usually she could go without her medication for chronic allergies in the winter. But she learned Friday from her doctor her runny nose and itchy eyes weren't symptoms of a cold as she suspected.
"Usually, the symptoms wouldn't be that prominent," Carola said of her allergies.
The most common allergy symptoms are itchy eyes, noses and throats, and possibly runny or stuffy noses, said Bassett. People with colds may share the stuffed up nose problem, but also may see changes in the color of their mucus, loss of appetite, fatigue, low-grade headaches or fevers.
Some doctors say a warm spell could bring a very early allergy season since trees might begin to bud early; others say the temperatures don't always make much of a difference.
Reuters coverage makes top stories list on Yahoo.
http://news.yahoo.com/s/nm/20061123/sc_nm/space_golf_dc
Russian cosmonaut slaps golf ball into orbit
By Erwin Seba Thu Nov 23, 8:53 AM ET
HOUSTON (Reuters) - Cosmonaut Mikhail Tyurin smacked a golf ball into orbit off the
International Space Station on Wednesday to raise money for the Russian space program during a spacewalk cut short by a balky spacesuit.
Tyurin, the station's flight engineer, made a one-armed swing with a gold-plated six-iron to send the lightweight ball on a journey estimated to take it around the Earth at least 48 times before it burns up in the atmosphere.
He spent 16 minutes setting up the shot off a ladder on a Russian docking module with the help of U.S. astronaut Michael Lopez-Alegria and the guidance of Russian flight controllers.
"OK, there it goes," said Tyurin, who has played golf twice in his life. "It went pretty far. It was an excellent shot."
Canadian golf club maker Element 21 Golf Co. paid the cash-strapped Russian space agency an undisclosed amount of money for Tyurin's golf exhibition, which was filmed for a future commercial.
Fixing a malfunctioning cooling line in Tyurin's Russian-made spacesuit delayed him and Lopez-Alegria from leaving the space station airlock by an hour, using up part of the carbon dioxide absorption capability of their suits.
Russian flight controllers ordered the pair back into the station's airlock about an hour short of the six hours planned for the spacewalk.
The spacewalkers were never in danger as they still had reserves of carbon dioxide absorbing materials available.
After the orbital golf exhibition, Tyurin and Lopez-Alegria struggled for more than an hour in an unsuccessful attempt to retract an antenna on the Russian Progress supply ship that is docked with the station.
"We just cannot free it," Station Commander Lopez-Alegria told flight directors. "No way."
While not an immediate threat to the astronauts' safety or the station, the Progress is scheduled to leave the station in January and the supply ship or the station could be damaged by the antenna during undocking.
A future spacewalk will likely be made to retract the antenna as Russian experts further study the problem, a
NASA spokesman said.
The pair successfully moved another antenna so it can communicate with the European Space Agency's automated supply vessel, scheduled to dock with the station in mid-2007.
The men also deployed an experiment that will study charged and neutral particles generated in low-Earth orbit by solar flares.
Form 10QSB for COBALIS CORP
20-Nov-2006
Quarterly Report
Item 2. Management's Discussion and Analysis or Plan of Operations
This following information specifies certain forward-looking statements of management of the company. Forward-looking statements are statements that estimate the happening of future events and are not based on historical fact. Forward-looking statements may be identified by the use of forward-looking terminology, such as "may", "shall", "could", "expect", "estimate", "anticipate", "predict", "probable", "possible", "should", "continue", or similar terms, variations of those terms or the negative of those terms. The forward-looking statements specified in the following information have been compiled by our management on the basis of assumptions made by management and considered by management to be reasonable. Our future operating results, however, are impossible to predict and no representation, guaranty, or warranty is to be inferred from those forward-looking statements.
The assumptions used for purposes of the forward-looking statements specified in the following information represent estimates of future events and are subject to uncertainty as to possible changes in economic, legislative, industry, and other circumstances. As a result, the identification and interpretation of data and other information and their use in developing and selecting assumptions from and among reasonable alternatives require the exercise of judgment. To the extent that the assumed events do not occur, the outcome may vary substantially from anticipated or projected results, and, accordingly, no opinion is expressed on the achievability of those forward-looking statements. No assurance can be given that any of the assumptions relating to the forward-looking statements specified in the following information are accurate, and we assume no obligation to update any such forward-looking statements.
Our Management's Discussion and Analysis of Financial Condition and Results of Operations section discusses our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. On an on-going basis, we evaluate our estimates and judgments, including those related to revenue recognition, accrued expenses, financing operations, and contingencies and litigation. We base our estimates and judgments on historical experience and on various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. The most significant accounting estimates inherent in the preparation of our financial statements include estimates as to the appropriate carrying value of certain assets and liabilities which are not readily apparent from other sources, primarily valuation of patent costs and stock-based compensation. The methods, estimates and judgments we use in applying these most critical accounting policies have a significant impact on the results we report in our consolidated financial statements.
OVERVIEW
As discussed above, we were incorporated in 1997 and on July 6, 2004 changed our name to Cobalis Corp., having previously used the BioGentech Corp. In 2003, we acquired our operational subsidiary, BioGentech Incorporated,(BioGentec). To distinguish between parent and subsidiary, a slight spelling difference was utilized. BioGentec, a private Nevada corporation, was incorporated on November 21, 2000 according to the laws of Nevada, under the name St Petka, Inc. On May 4, 2001, St. Petka, Inc. changed its name to BioGentec Incorporated. On July 2, 2003, BioGentec was merged into Togs for Tykes Acquisition Corp., a wholly owned subsidiary formed for the purpose of acquiring BioGentec. As allowed under SFAS 141, "Business Combinations" ("SFAS 141"), we designated a date of convenience of the closing for accounting purposes as June 30, 2003. Under the terms of the merger agreement, all of BioGentec's outstanding common stock (19,732,705 shares of $0.001 par value stock) was exchanged for 19,732,705 shares newly issued shares of $0.001 par value stock of Cobalis Corp. common stock. This transaction was consummated with the filing of the Articles of Merger with the State of Nevada on July 2, 2003. BioGentec shareholders then effectively controlled approximately 95% of the issued and outstanding common stock of Cobalis. Since the shareholders of BioGentec obtained control of Cobalis, according to SFAS 141, this acquisition was treated as a recapitalization for accounting purposes, in a manner similar to reverse acquisition accounting.
GOING CONCERN
The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America, which contemplate continuation as a going concern. We incurred a net loss of $5,348,854 for the six months ended September 30, 2006 and as of September 30, 2006; we had a working capital deficit of $5,842,234 and a stockholder deficit of $5,798,370. In addition, as of September 30, 2006, we have not developed a substantial source of revenue. These conditions raise substantial doubt as to our ability to continue as a going concern. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. The consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts, or amounts and classification of liabilities that might be necessary should we be unable to continue as a going concern.
We are currently attempting to raise additional debt and equity financing for operating purposes. We require substantial capital to pursue our operating strategy, which includes commercialization of our products, and we currently have limited cash for operations. Until we can obtain revenues sufficient to fund working capital needs and additional research and development costs necessary to obtain the regulatory approvals for commercialization, we will be dependent upon external sources of financing.
We believe that actions presently being taken to revise our operating and financial requirements provide the opportunity for us to continue as a going concern. There can be no assurances that sufficient financing will be available on terms acceptable to us, or at all. If we are unable to obtain such financing, we will be forced to scale back operations, which could have an adverse effect on our financial condition and results of operations.
CRITICAL ACCOUNTING POLICY AND ESTIMATES
Our Management's Discussion and Analysis of Financial Condition and Results of Operations section discusses our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America. The preparation of the consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. On an on-going basis, management evaluates its estimates and judgments, including those related to revenue recognition, accrued expenses, financing operations, and contingencies and litigation. Management bases its estimates and judgments on historical experience and on various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. The most significant accounting estimates inherent in the preparation of our consolidated financial statements include estimates as to the appropriate carrying value of certain assets and liabilities which are not readily apparent from other sources, primarily valuation of patent costs and stock-based compensation. The methods, estimates and judgments we use in applying these most critical accounting policies have a significant impact on the results we report in our consolidated financial statements.
Patent Cost Valuation. The determination of the fair value of certain acquired assets and liabilities is subjective in nature and often involves the use of significant estimates and assumptions. Determining the fair values and useful lives of intangible assets requires the exercise of judgment. While there are a number of different generally accepted valuation methods to estimate the value of intangible assets acquired, we primarily use the weighted-average probability method outlined in SFAS 144, "Accounting for the Impairment or Disposal of Long-Lived Assets." This method requires significant management judgment to forecast the future operating results used in the analysis. In addition, other significant estimates are required such as residual growth rates and discount factors. The estimates we have used are consistent with the plans and estimates that we use to manage our business, based on available historical information and industry averages. The judgments made in determining the estimated useful lives assigned to each class of assets acquired can also significantly affect our net operating results.
Stock-based Compensation. We adopted SFAS No. 123 (Revised 2004), Share Based Payment ("SFAS No. 123R"), under the modified-prospective transition method on January 1, 2006. SFAS No. 123R requires companies to measure and recognize the cost of employee services received in exchange for an award of equity instruments based on the grant-date fair value. Share-based compensation recognized under the modified-prospective transition method of SFAS No. 123R includes share-based compensation based on the grant-date fair value determined in accordance with the original provisions of SFAS No. 123, Accounting for Stock-Based Compensation, for all share-based payments granted prior to and not yet vested as of January 1, 2006 and share-based compensation based on the grant-date fair-value determined in accordance with SFAS No. 123R for all share-based payments granted after January 1, 2006. SFAS No. 123R eliminates the ability to account for the award of these instruments under the intrinsic value method prescribed by Accounting Principles Board ("APB") Opinion No. 25, Accounting for Stock Issued to Employees, and allowed under the original provisions of SFAS No. 123. Prior to the adoption of SFAS No. 123R, we accounted for our stock option plans using the intrinsic value method in accordance with the provisions of APB Opinion No. 25 and related interpretations.
Estimate of Litigation-based Liability. We are a defendant in certain claims and litigation in the ordinary course of business. We accrue liabilities relating to these lawsuits on a case-by-case basis. We generally accrue attorney fees and interest in addition to the liability being sought. Liabilities are adjusted on a regular basis as new information becomes available. We consult with our attorneys to determine the viability of an expected outcome. The actual amount paid to settle a case could differ materially from the amount accrued.
LIQUIDITY AND CAPITAL RESOURCES
We had cash and cash equivalents of $66,120 and prepaid expenses and other current assets of $32,991at September 30, 2006. Our total current assets at September 30, 2006 were $99,111. We also had the following long term assets:
$4,427 in property and equipment, net; $1,239 in net website development costs; $647,791 represented by net value of our patents; and $12,546 in deposits. Our total assets as of September 30, 2006 were $765,114.
Our total current liabilities were $5,941,345 at September 30, 2006, which was represented by accounts payable of $437,105; accrued expenses of $536,192; accrued clinical trials costs of $1,004,032; accrued legal settlements of $1,725,000; accrued salaries of $1,096,711; promissory notes of $46,813; notes payable of $495,492 and convertible notes payable of $600,000.
In June 2005, we converted a total of $205,174 of amounts due for clinical trials into nine promissory notes that accrued interest at a rate of 10% per annum and were due on December 27, 2005. During the three months ended March 31, 2006 and June 30, 2006, respectively, we converted $131,042 and $27,319 of these promissory notes plus accrued interest into 105,250 and 27,200 shares of our common stock. At September 30, 2006, $46,813 of these notes was still outstanding.
We also had $179,639 represented by a senior debenture, making our total liabilities $6,120,984, and a convertible preferred stock liability of $442,500. Our liabilities exceeded our assets by $5,355,870.
On July 18, 2006, we entered into an Accord and Satisfaction Agreement ("Agreement") with several related party creditors, arranging to settle debt of $5,194,553 including interest accrued through June 30, 2006, in exchange for the issuance of 3,995,809 shares of our $.001 par value common stock. This debt was incurred in the form of related party advances and services rendered to the company over recent months. The conversion rate was $1.30 per share, representing a premium on the market price of our closing share price on Monday, July 17, 2006 of $1.00 per share.
The related parties that are owed funds include Radul Radovich, our Chairman of the Board of Directors, and several entities owned and controlled by Mr. Radovich. The amounts owed were as follows: Mr. Radovich was owed $952,611 principal along with interest of $127,509, for a total of $1,084,120, which is to be converted to 833,938 restricted shares of our common stock; St. Petka Trust, a majority shareholder of the company, and of which Mr. Radovich is the beneficiary and trustor, was owed $1,585,500 principal, along with interest of $211,335, for a total of $1,796,835, which is to be converted to 1,382,180 restricted shares of our common stock; R and R Holdings, Inc. a Nevada corporation owned by Mr. Radovich, was owed $471,507 principal, along with interest of $62,848, for a total of $534,355, which is to be converted to 411,042 restricted shares of our common stock; Silver Mountain Promotions, Inc., a Nevada corporation, owned by Mr. Radovich, was owed $922,103 principal, along with interest of $122,909, for a total of $1,045,012, which is to be converted to 803,855 restricted shares of our common stock; R R Development, Inc., a California corporation, owned by Mr. Radovich, was owed $170,000 principal, along with interest of $51,838, for a total of $221,838, which is to be converted to restricted 170,644 shares of our common stock. In addition, Mr. Radovich was owed $512,392 for consulting fees, pursuant to a consulting contract with the company. This amount is to be converted to 394,147 restricted shares of our common stock. Subsequent to the period covered by this report, we issued these shares on October 17, 2006.
We have financed our operations primarily through cash generated from related party debt financing as well as issuing a convertible debenture.
Our net cash used by investing activities was $48,124 for the six months ended September 30, 2006 compared to $0 for the six months ended September 30, 2005. The increase of $48,124 is primarily due to a reduction in related party advances offset by an increase in the sale of notes payable and common stock.
Our net cash provided by financing activities was $740,000 for the six months ended September 30, 2006 compared to net cash provided by financing activities of $1,093,933 for the six months ended September 30, 2005. The decrease of $353,933 is primarily due to a reduction in related party advances offset by an increase in the sale of notes payable and common stock.
In June 2005, we entered into a loan agreement with Tejeda and Tejeda, Inc. in the amount of $100,000. The loan is due in one year. The note is personally guaranteed by Mr. Radul Radovich, the chairman of our board of directors, and Mr. Chas Radovich, our President, Secretary and one of our directors. When the loan is due, the holder of the note has the option to convert the loan into shares of our common stock at $0.50 per share or at a price equal to a 25% discount to the closing bid price on the day of conversion at maturity. In July 2006, the holder of the note elected to convert the note to 200,000 shares of our common stock. We recognized an additional expense of $91,583 related to the conversion of this note and accrued interest into shares of common stock.
In October 2005, we issued a senior debenture to the Brad Chisick Trust for $250,000 that accrues interest at 10% per annum, and is due in two years. We also issued the holder of this debenture a warrant to purchase 500,000 shares of our common stock at $1.75 per share.
During the three months ended June 30, 2006, we issued 111,416 shares of our common stock that were registered on or about May 11, 2006 on Form S-8 as payment for certain accounts payable, past due salaries to certain related parties and amounts due to consultants.
In July 2006, we issued notes payable in the aggregate amount of $250,000 to three investors. The notes bear interest at 5% per month and were due on September 14, 2006. We exercised its option to extend the due date to October 14, 2006 and issued to the investors a total of 25,000 warrants. These notes currently have not bee repaid.
In August 2006, the Company issued a note payable to MDC Enterprises Ltd. in the amount of $250,000 that accrues interest at 40% per annum and is due on December 29, 2006. In addition, the Company also issued to MDC Enterprises Ltd. a warrant to purchase 150,000 shares of the Company's common stock for $0.75 per shares.
In September 2006, the Company issued a note payable in the amount of $50,000 to an investor. The note bears interest at 10% per annum and is payable upon demand.
RESULTS OF OPERATIONS FOR THE THREE MONTHS ENDED SEPTEMBER 30, 2006 AS COMPARED TO THE THREE MONTHS ENDED SEPTEMBER 30, 2005
Revenues and Cost of Sales. We had no significant revenues for the three months ended September 30, 2006 and September 30, 2005 as we are undertaking a Phase III clinical trial in order to obtain FDA approval of PreHistinTM as an over the counter drug. Our net sales were $0, as were our cost of sales and gross loss for the three months ended September 30, 2006, as compared net sales of $0 as were our cost of sales and gross loss for the three months ended September 30, 2005.
Operating Expenses. Our operating expenses for the three months ended September 30, 2006 were $3,646,162 compared to $810,501 for the three months ended September 30, 2005. For both periods, we incurred expenses for two major purposes: i) ongoing development of our PreHistinTM product and related product management and ii) general management and fund raising efforts. For the three months ended September 30, 2006, this amount was represented by $14,515 in depreciation and amortization; $650,769 in professional fees; $918,330 in salary and wages; $37,203 in rent expense; $1,273,555 in marketing and research; $461,684 in stock option expense; and $290,106 in other operating expenses. This is compared to the three months ended September 30, 2005, where we had $21,401 in depreciation and amortization; $447,182 in professional fees; $95,653 in salary and wages; $34,487 in rent expense; $29,043 in marketing and research; and $182,735 in other operating expenses. Our operating expenses increased during the three months ended September 30, 2006 as compared to the three months ended September 30, 2005 principally as a result of an increase in salaries and wages due to the additions of two executives, an increase in marketing and research due to our Phase III clinical trials and an increase in stock option expense related to the adoption of SFAS No. 123R. A significant portion of the professional fees were paid by issuing shares of our stock. The value of these services was based on the market value of our stock at the measurement date.
Interest expense and financing costs for the three months ended September 30, 2006 were $100,340 compared to $225,635 for the three months ended September 30, 2005. The decrease is due to no non-registration penalties being accrued during the three months ended September 30, 2006 as compared to penalties of $96,000 during the three months ended September 30, 2005.
The change in the fair value in the warrant liability relates to the decrease in the value of the detachable warrants issued in connection with the convertible note payable and convertible preferred stock. Due to the decrease of our stock price, the fair value of these warrants has decreased resulting in the decrease of the warrant liability.
RESULTS OF OPERATIONS FOR THE SIX MONTHS ENDED SEPTEMBER 30, 2006 AS COMPARED TO THE SIX MONTHS ENDED SEPTEMBER 30, 2005
Revenues and Cost of Sales. We had no significant revenues for the six months ended September 30, 2006 and September 30, 2005 as we are undertaking a Phase III clinical trial in order to obtain FDA approval of PreHistinTM as an over the counter drug. Our net sales were $0, as were our cost of sales and gross loss for the six months ended September 30, 2006, as compared net sales of $0 as were our cost of sales and gross loss for the six months ended September 30, 2005.
Operating Expenses. Our operating expenses for the six months ended September 30, 2006 were $5,116,719 compared to $1,595,714 for the six months ended September 30, 2005. For both periods, we incurred expenses for two major purposes: i) ongoing development of our PreHistinTM product and related product management and ii) general management and fund raising efforts. For the six months ended September 30, 2006, this amount was represented by $31,277 in depreciation and amortization; $1,567,674 in professional fees; $1,103,632 in salary and wages; $100,279 in rent expense; $1,299,364 in marketing and research; $590,592 in stock option expense; and $423,901 in other operating expenses. This is compared to the six months ended September 30, 2005, where we had $46,283 in depreciation and amortization; $958,360 in professional fees; $178,220 in salary and wages; $68,923 in rent expense; $55,316 in marketing and research; and $288,612 in other operating expenses. Our operating expenses increased during the six months ended September 30, 2006 as compared to the six months ended September 30, 2005 principally as a result of an increase in professional fees, which include payments for accounting, legal and shareholder relations and amortization of the value of warrants issued to consultants over the terms of the related consulting agreements, an increase in salaries and wages due to the additions of two executives, an increase in marketing and research due to our Phase III clinical trials and an increase in stock option expense related to the adoption of SFAS No. 123R. A significant portion of the professional fees were paid by issuing shares of our stock. The value of these services was based on the market value of our stock at the measurement date.
Interest expense and financing costs for the six months ended September 30, 2006 were $232,135 compared to $408,367 for the six months ended September 30, 2005. The decrease is due to no non-registration penalties being accrued during the six months ended September 30, 2006 as compared to penalties of $192,000 during the six months ended September 30, 2005.
The change in the fair value in the warrant liability relates to the decrease in the value of the detachable warrants issued in connection with the convertible note payable and convertible preferred stock. Due to the decrease of our stock price, the fair value of these warrants has decreased resulting in the decrease of the warrant liability.
OUR PLAN OF OPERATION FOR THE NEXT TWELVE MONTHS.
Over the next 12 months, we plan to continue moving forward with the completion of the Phase III clinical trials of our allergy prevention product, PreHistinTM, followed by submission of a new drug application ("NDA") to the FDA for marketing approval of PreHistinTM as an over the counter ("OTC") allergy medication. Once the NDA is filed, we hope to receive approval from the FDA enabling our marketing launch in the United States of the product or licensing to a potential pharmaceutical partner. We estimate the cost to complete the Phase III clinical trials and the submission of the NDA to the FDA for marketing approval will be approximately $5,000,000.
In addition to seeking approval from the FDA for the primary indication of seasonal allergic rhinitis (hay fever) for PreHistinTM, we may conduct additional studies to validate the viability of approval for supplemental indications and alternative delivery mechanisms. The tests will be a combination of clinical trials and laboratory analyses.
As of September 30, 2006, we had cash and equivalents of $66,120. To fully execute our business plan for the next 12 months, we will need to raise additional funds in order to complete the Phase III clinical trials, submit the PreHistinTM application to the United States FDA, and execute a licensing agreement or otherwise launch the PreHistinTM product. There is no assurance that these funds will be raised.
In October 2005, we reported results of an initial six-week 714 patient Phase III trial designed to study various PreHistinTM dose regimens for reducing seasonal allergy symptoms when compared to placebo. As reported, the statistical analysis utilized a modified intent to treat and an ANOVA (ANalysis Of VAriation) model to determine the treatment effects for the four arm study and certain assumptions used were not specified in the statistical analysis plan (SAP). Although the data resulting from the prior Phase III clinical trial demonstrated that patients who were administered PreHistinTM showed a statistically significant reduction of allergy symptoms when the modified analysis was applied, the data most likely will be viewed by the FDA as supportive data and not as pivotal Phase III results required to secure approval.
In June 2006, we announced that we intend to initiate two identical, Phase III clinical trials of our anti-allergy medication PreHistinTM in patients with seasonal allergic rhinitis. The randomized, double blind, placebo-controlled studies are intended to assess the efficacy, overall safety and tolerability of our flagship drug PreHistinTM to prevent the onset and reduce the severity of allergy symptoms.
The new study design calls for two simultaneously conducted Phase III clinical trials, each comprised of one placebo arm and one active arm receiving 3.3 mg of sublingual PreHistinTM administered twice daily for the six weeks of the study. In July 2006, we conducted the double blind, placebo-controlled trials will be conducted at 23 sites throughout the United States during the Ragweed allergy season. The trials utilized electronic diary records to assess improvement in the severity of nasal allergy symptoms. A total of 1,550 patients were randomized into the twin studies to receive either placebo or PreHistinTM for three weeks prior to the onset of the allergy season, and for an additional three weeks into the season. The patients' diaries and studies were completed on October 6, 2006.
We estimate these costs to be approximately $5,000,000 over the coming year. We will need to raise funds to execute studies for the further development of the . . .
Bravo! Brands Operational Update: Production Capacity, Product Development and Marketing Initiatives
Monday November 20, 8:00 am ET
NORTH PALM BEACH, Fla., Nov. 20 /PRNewswire-FirstCall/ -- Bravo! Brands Inc. (OTC Bulletin Board: BRVO - News), a brand development and marketing company that promotes and distributes vitamin-fortified, flavored milk drinks and other beverages, today provided an update of recent developments regarding the company's production capacity, product innovations and marketing initiatives.
Production Capacity
Bravo! significantly improved its production capacity and resolved its capacity constraint for shelf stable plastic bottles with the signing of its recent agreement with HP Hood. Today the Company has 160 million bottles of guaranteed production commitments for Bravo!'s various lines of shelf-stable, single-serve flavored milk beverages. 70 million of this capacity was obtained with the production agreement signed with HP Hood. Hood will begin shipments from its East Coast facility on December 15, 2006 with full volume shipments of 70 million bottles forecast for 2007. This increase in production capacity eliminates the constraints experienced by the Company earlier in the year and uniquely positions the company with guaranteed production of shelf stable plastic bottles.
In addition, as previously announced, the Company has developed an 8 ounce and 14 ounce plastic vendible bottle. Bravo! began shipping the 8 ounce bottle in early November. The 8 ounce bottle filled with 100% milk meets the ABA Clinton Foundation Guidelines and will give Bravo! and CCE a first-to- market advantage in the school a la carte and vending arena.
Product Development
Bravo!'s brand development continues to expand with the Organic Valley relationship. As previously announced, Bravo! and Organic Valley will jointly co-brand organic shelf stable dairy based single-serve beverages. This is Bravo!'s first foray into organic milk. The Company will be offering organic white milk in schools in the 4th quarter of 2006 with flavored organic milks expected to be offered in 2007.
The Company also announced it will initiate a launch of several new products with Bravo! Dove in the beginning of 2007. In addition to the Bravo! Dove launch, four new brands of dairy-based beverages will be introduced in 2007. These products will all be in distinct categories from the products the Company has previously developed. The Company also announced that it had initiated the development of an alternative distribution system for new products innovations, including Bravo! Blenders, Slammers Trix and Cocoa Puffs, that will not be sold through the Coca Cola Enterprise distribution system.
The Company's existing co-branding agreement with General Mills continues to result in additional new product development and introductions. Trix and Cocoa Puffs Slammers are currently being launched.
Marketing Initiatives
Coca-Cola Enterprises continues to increase its purchases of Bravo! products. Third quarter case shipments of Bravo! products by CCE increased by 49% over the second quarter. Even with the significant increase in cases shipped in the third quarter by CCE, Bravo! products were only sold to one out of 20 CCE accounts indicating the growth potential for Bravo!s products within the CCE system.
In September Bravo! successfully launched Bravo! Blenders(TM) in the New York metropolitan area. Bravo! held sampling events for Bravo! Blenders(TM) during the morning and afternoon commute times in such venues as Grand Central Station, Penn Station and the Wall Street Area. Additional spontaneous samplings throughout Manhattan were held over the course of three days. By the end of October, Bravo! Brands distributor, a wholly owned subsidiary of Arizona Ice Tea had opened over 3,000 accounts. Most of these accounts are in the small supermarkets, delis, convenience stores as well as several colleges including Hofstra University and Seton Hall University. Bravo! plans to introduce Bravo! Blenders(TM) to additional colleges as well as high schools in the New York metropolitan area. Approximately 28,000 cases of Bravo! Blenders(TM) were shipped in September and October during this introductory period.
The Company also announced that Masterfoods had extended its licenses with Bravo! to 2012 and General Mills established a 2011 timeframe on its licenses with the company.
Roy Warren, Chief Executive Officer, commented, "In the third quarter we experienced a significant increase in sales. Our customers are growing on a regular and steady basis." Mr. Warren further added, "We are determined to increase our brand recognition and have four new products in the dairy based beverage industry that we plan to introduce in 2007. These products are separate and distinct categories from anything we have previously developed. We have spent a considerable amount of preparation in the development of these products and are anxious to introduce them into the marketplace as we believe they will be well accepted."
About the Company
Bravo! Brands Inc. develops, brands, markets, distributes and sells nutritious, flavored milk products throughout the 50 United States, Great Britain and various Middle Eastern countries. Bravo!'s products are available in the United States and internationally through production agreements with regional aseptic milk processors and are currently sold under the brand names Slammers® and Bravo!(TM). Bravo!'s Slammers® products are available nationwide in popular chains such as: 7-Eleven, A&P, Dutch Farms, Giant Food Stores, Jewel, Kings, Pathmark, Safeway, Sam's Club, Shaw's, ShopRite, Speedway, SuperTarget, Unified, Waldbaums and Walgreens.
Many of Bravo! Brands' Slammers® lines of shelf-stable, single-serve milk drinks are co-branded through exclusive partnerships with Masterfoods, a division of Mars Incorporated, General Mills, Organic Valley, and MD Enterprises (Moon Pie®), providing superior name recognition packaged with quality, great-tasting drinks.
On November 1, 2005, Coca-Cola Enterprises, Inc. began distribution of the Slammers® Masterfoods line, as well as the Bravo!'s Slim Slammers® and Pro Slammers(TM) products, under a Master Distribution Agreement with Bravo!
For more information, visit: http://www.bravobrands.com
Forward Looking Statements
Safe Harbor under the Private Securities Litigation Reform Act of 1995: The statements which are not historical facts contained in this press release are forward-looking statements that involve certain risks and uncertainties including but not limited to risks associated with the uncertainty of future financial results, regulatory approval processes, the impact of competitive products or pricing, technological changes, the effect of economic conditions and other uncertainties as may be detailed in the Company's filings with the Securities and Exchange Commission.
Investor Relations Contact
Integrated Corporate Relations
Julia Heckman (203) 247-7275
Kathleen Heaney (203) 803-3585
Company Contact
Jeffrey J. Kaplan, Chief Financial Officer
(561) 625-1411
Source: Bravo! Foods International Corp.
Randy,
Thanks for the clarification.
But taking shares as compensation instead of cash is still a show of confidence in the future of the company... IMHO
Scary
Insiders buying over the past few months.
Great show of confidence.
Date Insider Shares Type Transaction Value*
1-Nov-06 RADOVICH RADUL
Director 302,083 Indirect Acquisition (Non Open Market) at $0.95 per share. $286,978
1-Nov-06 ARMSTRONG ERNEST
Officer 95,563 Direct Acquisition (Non Open Market) at $0.95 per share. $90,784
1-Nov-06 RADOVICH CHASLAV
Officer 302,083 Direct Acquisition (Non Open Market) at $0.95 per share. $286,978
1-Nov-06 YAKATAN GERALD J PHD
Officer 362,500 Direct Acquisition (Non Open Market) at $0.95 per share. $344,375
1-Nov-06 STANKOVICH THOMAS
Officer 178,070 Direct Acquisition (Non Open Market) at $0.95 per share. $169,166
17-Oct-06 YAKATAN GERALD J PHD
Officer 200,000 Direct Acquisition (Non Open Market) at $0.95 per share. $190,000
17-Oct-06 RADOVICH RADUL
Director 2,108,699 Indirect Acquisition (Non Open Market) at $0.90 - $1.3 per share. N/A
17-Oct-06 RADOVICH RADUL
Director 1,228,085 Direct Acquisition (Non Open Market) at $1.30 per share. $1,596,510
17-Oct-06 RADOVICH CHASLAV
Officer 3,995,806 Indirect Acquisition (Non Open Market) at $1.30 per share. $5,194,547
17-Oct-06 RADOVICH CHASLAV
Officer 100,000 Direct Acquisition (Non Open Market) at $0.90 per share. $90,000
Any news before year end would most likely be financing news or partnership news.
As per the latest Cobalis release, "Cobalis anticipates
reporting top-line efficacy results from the pivotal trials in the first quarter of 2007."
So we will have to wait until then for any trial data.
ScaryStocks
I hope they will have some good news to announce at the meeting. (Partnerships, funding, positive trial results, etc...)
That is good news.
Cobalis needs to go to more investor conferences as well as some scientific conferences to get the word out.
I can't wait to hear the webcast.
With a $3 billion market, the potential for CLSC is huge. This is the type of news for CLSC that Mike has been hinting about for some time. One can only hope.
From the Inspire and FAES news release:
"About Rhinitis
Rhinitis is a condition that primarily results from exposure to allergens, either at specific times of the year (seasonal allergic rhinitis) or year-round (perennial allergic rhinitis), or from exposure to irritants, such as cigarette smoke or perfume. Symptoms most often include nasal congestion or stuffiness, rhinorrhea (runny nose) and nasal itching. In the United States, allergic rhinitis affects approximately 40 million people, according to the American Academy of Allergy, Asthma & Immunology. Annual sales of oral antihistamine products to treat allergic rhinitis are estimated by IMS Health to total more than $3 billion."
IBZT
The IBIZ Virtual Laser Keyboard... big pump and dump scam.
This link says it all...
http://www.sec.gov/litigation/litreleases/lr19571.htm
Randy, I agree.
I follow several small stocks that reference larger competitors in their news releases. This way they pop up on your radar screen whenever there is news.
Now if CLSC's PR firm followed that advice...
Todays news is great...
but the PR firm needs to get it out to a wider audience.
Look at the impact that the DVAX news had for such a small study group. And they are further away from a marketable product that CLSC.
There is no reason we shouldn't be above $4 PPS (at least)
Rawnoc,
I have been watching UWNK and got in early enough for a double (so far still holding).
So I think its good karma to return the favor.
CLSC is a small biotech that is in phase III for an OTC for allergies.
Do some DD and you will see that the $1 stock is worth $4 for it's patents alone.
Big news today (see link)
http://www.investorshub.com/boards/read_msg.asp?message_id=13957203
ScaryStocks
Big News Today!!!
Looks like my wish for news came true.
Now if more people would catch on to this, that would be something.
It would be great to see some updates on the progress in the form of news releases. For example, letting the public know when the trail phases are done and then to set time lines going forward for submittal.
I know there is a timeline on the web site. But updates might stir some interest in this stock.
As Mike has noted, that patents alone are worth a $4 PPS. This stock has huge potential.
All IMHO
ScaryStocks
OK. Let's just agree that we are heading in the right direction. No need to argue. Here is what we know from the Cobalis site:
Clinical Trials and Product Milestone Timetable
Following is Cobalis' domestic planning for completion of Phase III Clinical Trials and initial market introduction of PreHistin™ in the US.
First Phase III Clinical Trial completed with 714 patients
Twin Phase III Clinical Trials commencing July 2006; target completion late 2006
Break blind on data and commence statistical analyses of second study data- Q1 07
Submit NDA (New Drug Application) to FDA – Q3 2007
FDA Review completed Q2-Q3 2008
If approved, US marketing launch 2008
There are Twin Phase III trails in play here. Perhaps one of them is finishing now. Maybe, maybe not. If longmike is right and we get news, great. If not, then we wait some more.
ScaryStocks
beachgal,
No problem. It is my pleasure to help run the board.
When PreHistin is approved and the Cobalis stock price rises, you can buy me a beer at the victory party.
ScaryStocks
Beachgal,
I sent the New England Journal article to the Cobalis mailing list that is part of this message board. So anyone who signed up for the Coablis list got my e-mail. I guess it doesn't link it to my screen name (sorry, but maybe an issue for IHUB to look at)
No big deal. I am glad you found it useful.
ScaryStocks
Randy, It is still great to see the potential for this market and the extent of the public's interest.
The big move in dvax pps shows the potential that Cobalis has in the future to really move.
Scary
I learned about Dvax on Yahoo last night. It was one of the top stories on the Yahoo home page. So Dvax is doing a great job in getting the word out.
That is what we need to happen for Cobalis. We need a great PR machine to spring into action as news unfolds.
ScaryStocks
Not dead yet...
1. Neither Cobalis nor Dynavax have FDA approval yet. So who knows. The FDA is always the big wild card!
2. Dynavax is still a long way from a marketable product... "Even if larger tests confirm the findings, published in the New England Journal of Medicine, the shots probably wouldn’t be available to the public until 2009 or 2010 at the earliest."
3. Many people do not like shots.
4. There are flu shots and over the counter products that co-exist.
5. I think it will be more difficult for this new shot to complete the approval process.
This is all IMHO.
ScaryStocks
New hay fever vaccine shows promise
By ALEX DOMINGUEZ, Associated Press Writer 39 minutes ago
BALTIMORE - Could the sneezy, runny-eyed misery of hay fever one day be a thing of the past? Scientists are reporting encouraging results from early tests of a vaccine they hope will give long-lasting relief from this seasonal scourge.
The experimental vaccine has been tested on only a couple of dozen people so far, but it substantially relieved symptoms for those who received it in six weekly shots, and the benefit lasted for at least two years, doctors reported in Thursday's
New England Journal of Medicine.
The vaccine "holds great promise," said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, which helped fund the study. "A short course of immunotherapy that reduces allergic symptoms over an extended period of time will significantly improve the quality of life for many people."
Up to 40 million Americans suffer from hay fever, caused by an allergy to ragweed pollen, which is most common in the Northeast, Midwest and the South, especially in late summer and early fall.
To relieve symptoms, many take antihistamines and other medications. But the only option for longer-lasting relief has been dozens of shots over three to five years to try to sensitize the immune system. This helps only about a third of patients, and many of them give up before the series of shots is completed. There is also the risk of an allergic reaction to the shots.
The study tested a vaccine made by California-based Dynavax Technologies. It was led by Dr. Peter Creticos, director of Johns Hopkins University's Asthma and Allergy Center, and included researchers from the company.
Hay fever sufferers were given either six shots of the vaccine or dummy shots. The vaccine did not improve the main measurement doctors were using to gauge its effectiveness — a drop in a protein in mucus that is normally lower after traditional allergy shots.
However, the vaccine reduced symptoms of sneezing, runny nose and eyes, and itchy ears and throats by 60 percent on average in the 14 who received it compared with the 11 who did not. The eight vaccine recipients who stayed in the study a second year said they continued to benefit even though they were not given any more shots.
"They're all saying the same thing to a T — `I don't have problems in the fall anymore,'" Creticos said.
The company plans a larger study of the vaccine.
Dr. Jordan Fink, a Medical College of Wisconsin professor and past president of the American Academy of Allergy, Asthma and Immunology, said a vaccine that changes an allergic individual's immune response without the risk of big side effects has been a goal of allergists for years.
The vaccine needs far more study, but "may be a boon to treatment of allergic patients," he said.
___
On the Net:
New England Journal: http://www.nejm.org
Randy,
Since PreHistin is B-12 and does not contain any ephedrine, pseudoephedrine or phenylpropanolamine, consumers will be able to get PreHistin easier than other allergy medicines.
Sounds like good news to me.
ScaryStocks