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BEHL-BioCen Natural Products Development Group (BNPD) Signs Letter of Intent for Acquisition of the BioCentric Energy (BEHL) Assets
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Press Release Source: BioCen Natural Products Development Group On Monday September 13, 2010, 2:17 pm
SANTA ANA, Calif., Sept. 13, 2010 (GLOBE NEWSWIRE) -- BioCen Natural products (Pink Sheets:BNPD - News) (Formerly Bionic Products, Inc) President Daniel J. Kennedy today announced, "We are pleased to announce that on Friday, September 10, 2010, negotiations commenced for the acquisition of BioCentric Energy (Pink Sheets:BEHL - News) Assets and a formal Letter of Intent was signed. The Companies have a goal to complete this acquisition and Form S-1 Registration within 90 days."
"BNPD will acquire all hard and soft assets of BEHL including, but not limited to, all furniture and equipment, computers, software, intangibles, licenses, and intellectual property. In return, the BEHL shareholders will receive a free trading stock dividend of BNPD upon completion of the S-1 filing becoming effective. The stock divided ratio and qualifying date of holding for BEHL shareholders of record will be announced this week by the Board of Directors of BioCentric Energy Holdings, (Pink Sheets:BEHL - News)".
"During this transition period, BNPD will continually honor our seventy-five thousand ($75K) a month payment for the Master Sales Exclusivity Agreement with BEHL."
BNPD President Daniel J. Kennedy further commented, "We are looking forward to working with our shareholders during this transition period and will provide continued transparency towards meeting our goals and objectives in becoming the leader in natural algae based products and brands."
The BioCen Natural Products Development Group logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=7886
Safe Harbor Statement: This release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally can be identified by phrases such as BNPD or its management "believes," "expects," "anticipates," "foresees," "forecasts," "estimates" or other words or phrases of similar import. Similarly, statements herein that describe the Company's business strategy, outlook, objectives, plans, intentions or goals also are forward-looking statements. All such forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those in forward-looking statements.
92 L models show movement to southern gulf.
BEHL ready to go. All buys this AM
TD 9 will be the one to watch
APCX going
APCX Bid building
APCX Huge volume...bounce coming
Invest 99L forming North of PR. Will be intresting to watch through the weekend.
Invest 99L forming North of PR. Will be intresting to watch through the weekend.
Thank you for the response Sheff. I do plan to hold till Oct. I guess a positive is that is has held up pretty well in a tough market.
Any words of encouragement on ALXA? Tough to watch especially on a big market move like today.
I hope that wasnt our only pop....This storm is going to be a big one....
ALXA-Alexza Offers Pipeline Update
Alexza Pharmaceuticals Inc.Transcept Pharmaceuticals, Inc.
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ALXA 2.94
Jason Napodano, CFA, On Wednesday July 14, 2010, 3:59 pm
Management Selects AZ-007 to Move Forward
On July 12, 2010, Alexza Pharmaceuticals (NasdaqGM: ALXA - News) announced, after completing its technology and portfolio review during the first half of 2010, that is has selected AZ-007 as the next candidate to move forward in clinical trials. Alexza is developing AZ-007 (Staccato zaleplon) for the treatment of insomnia in patients who have difficulty falling asleep, including those patients who awake in the middle of the night and have difficulty falling back asleep.
Zaleplon is a non-benzodiazepine hypnotic currently approved to treat insomnia marketed under the brand name Sonata. It is widely available as a generic. The product has a pharmacokinetic half-life of about one hour and is generally well tolerated in patients. Alexza has combined the technology attributes of the Staccato system with zaleplon in order to develop a product candidate with a specific profile for middle of the night (MOTN) insomnia.
Phase I Demonstrates Potential
In a Phase 1 clinical trial, AZ-007 delivered an IV-like pharmacokinetic (pk) profile with a median time to peak plasma concentration for the drug of 1.6 minutes. Pharmacodynamics (pd), measured as sedation assessed on a 100 mm visual analog scale, showed onset of effect as early as 2 minutes after dosing with AZ-007.
AZ-007 was dose-proportional across the four dosage strengths studied in this clinical trial, and was generally safe and well tolerated in this volunteer population. These are highly encouraging results. The pk/pd profile of AZ-007 looks superior to any approved insomnia drug we have seen, and is ideal for a MOTN indication.
A Significant Opportunity
We estimate that nearly 70 million American adults (30% prevalence rate) are affected by some form of insomnia or sleep disorder. This can be characterized as difficulty falling asleep, waking frequently during the night and not being able to return to sleep, waking up not feeling refreshed, or a combination of all three.
Approximately a third of insomnia patients report nocturnal awakenings with difficulty returning to sleep. In greater than 75% of these patients, there is no observed difficulty in falling asleep. Thus, existing medications that offer only sleep onset claims do little to solve the problem. Research shows that 35% of the general population reports awakening at least 3 nights per week. We see a significant void in the insomnia market for that 35% of the adult population that suffer from nocturnal awakenings.
In fact, according to the Stanford Sleep Epidemiology Research Center, only around 11% of these patients seek physician consultation about their insomnia. Perhaps this is due to the lack of effective treatment options. Ambien and generic zolpidem are approved for sleep onset only, and are recommended for use only when the patient can devote 7 to 8 hours to sleep. The current Ambien label precludes MOTN dosing.
Both Lunesta and Ambien CR are approved for sleep onset and maintenance. The drugs are designed to put you to sleep and keep you asleep all night long. However, data shows that over half the patients that take Lunesta and Ambien CR still report nocturnal awakenings.
The ideal pharmaceutical product to address this unmet medical need would be an oral pro re nata (as needed) dosing of a rapidly effective molecule with a short half-life that can be taken with little to no next-day residual effects as soon as 3 to 4 hours later. Chronic patients typically suffer from nocturnal awakenings 3 to 4 times a week.
With AZ-007, we expect to see a rapid and predictable onset of therapeutic action resulting from Staccato administration, and a short-lived duration of action resulting from the pharmacological half-life of zaleplon. The proposed PRN dosing for AZ-007 eliminates necessary dosing of Ambien CR or Lunesta each night, and eliminates potentially dangerous dosing of Ambien or generic zolpidem in the middle of the night.
It’s an attractive opportunity in our view, and one that is currently wide open. There are no prescription products on the market with an approved MOTN dosing. Transcept Pharma (NasdaqGM: TSPT - News) is in the process of satisfying an FDA complete response letter on Intermezzo. Intermezzo is a sublingual, rapid-acting dose of zolpidem, which we project will be on the market by the second half of 2011.
This market is clearly large enough to support both products. AZ-007 could compete effectively with Intermezzo for market share in this $500+ million category.
New spill factor: La Nina could add to storms
Ocean system forming, adding to already high Gulf hurricane threat
updated 7/8/2010 11:21:48 AM ET
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NEW YORK — A La Nina weather pattern, the opposite of its more infamous cousin El Nino, will likely ramp up in July and August, potentially boosting hurricane formation in the Gulf of Mexico, the U.S. Climate Prediction Center forecast on Thursday.
"La Nina conditions are likely to develop during July-August 2010," the CPC, an office under the National Oceanic and Atmospheric Administration, stated in its monthly update.
La Nina spawns colder-than-normal waters in the equatorial Pacific Ocean. In contrast, El Nino is an abnormal warming of those waters. Both wreak havoc in the weather from the U.S. to India and occur every three to four years.
The emergence of a La Nina is of particular concern to the oil industry in the Gulf, already reeling from the massive oil spill caused by a leaking BP well.
Several forecasters have said the number of hurricanes striking the United States increases sharply during La Nina years and shrinks when El Nino hits.
Increased wind shear in an El Nino tends to rip apart embryonic storms in the Atlantic basin and Caribbean Sea. But those winds are limited in a La Nina year, allowing storms to flourish.
Last May, NOAA predicted this Atlantic storm season could be the worst since the record-breaking 2005, when Hurricane Katrina ravaged New Orleans, Hurricane Wilma slammed into Florida's citrus groves, and Hurricane Rita hit hard the oil rigs in the Gulf and refineries along the Gulf Coast.
NOAA forecast up to 23 named storms, of which 14 could power up to hurricanes. A record 15 hurricanes struck in 2005. June has already produced the first hurricane in 15 years, Alex, which dissipated in Mexico last weekend.
Storms are a particular concern in the Gulf, which holds about 27 percent of the U.S.'s oil and 15 percent of its natural gas, according to the federal Department of Energy.
Corn Belt could see dry spell
La Nina also poses a threat to crops in the U.S. Midwest and in countries like agricultural powerhouses Brazil, Argentina and India.
New spill factor: La Nina could add to storms
Ocean system forming, adding to already high Gulf hurricane threat
updated 7/8/2010 11:21:48 AM ET
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NEW YORK — A La Nina weather pattern, the opposite of its more infamous cousin El Nino, will likely ramp up in July and August, potentially boosting hurricane formation in the Gulf of Mexico, the U.S. Climate Prediction Center forecast on Thursday.
"La Nina conditions are likely to develop during July-August 2010," the CPC, an office under the National Oceanic and Atmospheric Administration, stated in its monthly update.
La Nina spawns colder-than-normal waters in the equatorial Pacific Ocean. In contrast, El Nino is an abnormal warming of those waters. Both wreak havoc in the weather from the U.S. to India and occur every three to four years.
The emergence of a La Nina is of particular concern to the oil industry in the Gulf, already reeling from the massive oil spill caused by a leaking BP well.
Several forecasters have said the number of hurricanes striking the United States increases sharply during La Nina years and shrinks when El Nino hits.
Increased wind shear in an El Nino tends to rip apart embryonic storms in the Atlantic basin and Caribbean Sea. But those winds are limited in a La Nina year, allowing storms to flourish.
Last May, NOAA predicted this Atlantic storm season could be the worst since the record-breaking 2005, when Hurricane Katrina ravaged New Orleans, Hurricane Wilma slammed into Florida's citrus groves, and Hurricane Rita hit hard the oil rigs in the Gulf and refineries along the Gulf Coast.
NOAA forecast up to 23 named storms, of which 14 could power up to hurricanes. A record 15 hurricanes struck in 2005. June has already produced the first hurricane in 15 years, Alex, which dissipated in Mexico last weekend.
Storms are a particular concern in the Gulf, which holds about 27 percent of the U.S.'s oil and 15 percent of its natural gas, according to the federal Department of Energy.
Corn Belt could see dry spell
La Nina also poses a threat to crops in the U.S. Midwest and in countries like agricultural powerhouses Brazil, Argentina and India.
WTFFFFFFFFFFFFFFF
Same thing happened last year to ASFX. Went to penny then dropped down to .003 then back to 8 cents.
think this will be a multi day runner?
Could this be a multi day runner?
whats going on with thse trades?
STHG running
I normally think all that MM crap is BS however after watching this today it does seem they are playing games to keep it lower
Same haapened to me..
Anyone have buys vs sells? Seems like more buying and still down.
AVNR- The Sky's the Limit for Avanir Pharmaceuticals
Recent accomplishments for Avanir (AVNR) marked the most exciting quarter in the history of the company, and it is highly likely that big news is on the near-term horizon. Avanir’s share price closed at $2.67, a gross undervaluation, in Friday's trading session. I expect Avanir’s share price to easily double prior to October when the FDA is expected to approve its key drug, Zenvia. And the stock price should easily reach $10 per share by early 2011, the expected launch time of Zenvia. The details of my analysis will be presented later in this article, but first, I will address the key drivers that make Avanir a compelling “buy and buy more” proposition:
Promising Pipeline with Expandable Applications
The Company’s lead product candidate, Zenvia (dextromethorphan hydrobromide/quinidine sulfate), has completed three Phase III clinical trials for the treatment of pseudobulbar affect (PBA) and has completed a Phase III trial for the treatment of patients with diabetic peripheral neuropathic pain (DPN pain). In the past 3 months, three firms (Wedbush, Cantor Fitzgerald, and Cannacord Adams) gave price targets that are more than 2 to 3 times the current share price.
Wedbush analyst Mike King describes, "Avanir is currently an off-the-radar-screen company developing Zenvia, a late-stage asset for the treatment of pseudobulbar affect. PBA is itself a little-recognized, but serious and debilitating, disorder that typically is a consequence of any one of several neurologic insults, such as MS, ALS, or TBI...An investment in Avanir is reminiscent of the opportunity presented to investors when Fampridine-SR was in early development for Acorda (ACOR), which currently boasts a valuation of ~$1.5 billion."
Quite noteworthy is that the company should have a broad label for all patients that have PBA. As per Keith Katkin, CEO of Avanir, " as has been the agreement all along with the FDA, if we study Zenvia in two separate neurologic populations, like we did in the STAR trial, then that should be sufficient for a broad label for all patients that have PBA." What is most exciting is the company’s strategy for future expansion, using Zenvia PBA approval as the express gateway to approval of many different types of pain applications, making the sky the limit for Avanir.
2Q2010 Developments
Avanir’s management accomplished several key milestones in the second quarter:
Patent protection - The Company received long-term (15 year) patent protection on Zenvia, securing its monopoly on Zenvia for years to come.
Extremely Positive Data - Avanir provided extremely positive safety and efficacy data at the American Academy of Neurology meeting and American Psychiatric Association meeting. They also showed tolerability with common drugs Paroxetine (a common antidepressant) and Memantine, a drug Merz +Co and Forest Labs (FRX) market for ALS patients. Commenting on the AAN meeting, Keith Katkin, CEO of Avanir, states "...the physician interest level in PBA is significant and reinforces our belief there is a large unmet medical need". As a Merriman Analyst commented, "Avanir Pharmaceuticals is advancing its lead product, Zenvia, for the unique indication of pseudobulbar affect, a hitherto little-known neurological condition that may affect millions of individuals…In our view, the Phase III STAR trial data are compelling…” Evidence of the excitement about Zenvia is apparent when looking at the stock price action after the Jeffries & Company (JEF) Health Sciences presentation by Avanir on June 8. The stock price had greater than a 25% upward move in a matter of a few days. Also notable is the trading volume in the $5.00 December calls. And furthermore, Avanir boasts institutional holders such as Blackrock, which is one of the most respected hedge funds on the street.
Early start on marketing/awareness efforts- Awareness of PBA is growing and the management team is diligently preparing for commercial launch. Top talent Michael McFadden was hired. Mr. McFadden previously managed markets at Amylin Pharmaceuticals (AMLN). When asked by an analyst of upcoming events prior to approval, Keith Katkin responded, "...you'll see PBA awareness advertorials within all of the medical journals. You'll also see them in the patient-focused journals…"Also, Avanir will attend "a dozen" different neurology and psychiatry meetings. Also, quite noteworthy is that AVNR partnered with ITV and PBS and will be airing a series on PBS stations (estimated late-June to early July) about the impact of PBA on patients' lives. Cannacord Adams analyst comments “AAN doctor opinion on Zenvia has been positive; we think that Zenvia will see good patient and doctor acceptance…”
Raised Capital – Debt-freeAvanir raised over $26 million through a recent stock offering such that Christine Ocampo, CFO of Avanir, stated "we expect our current cash on hand will be adequate to fund continuing operations and the clinical development of Zenvia through the anticipated FDA approval decision date..."
FDA Submission - The Company provided the FDA with all data needed to assess Zenvia in PBA. Approval is extremely likely as Zeniva's two major components are not new molecular entities and the response letter submitted was solid. After reviewing the submission, Cannacord analyst commented “…any delay would be minor and not reflect negatively on Zenvia’s approvability or sales potential.” Investors will remember Dendreon’s (DNDN) situation after receiving an approvable letter from the FDA, its engagement in subsequent studies, and ultimately approval which turned a $4 stock into one that now trades above $37.
Valuation
In my valuation of the company, I will disregard the current royalties received from GlaxoSmithKline (GSK) on Abreva sales (approximately $3-$4 million expected this year) and will focus solely on Zenvia, which would be the first drug approved to treat PBA. Per Randall Kaye, Chief Medical Officer, the prescribed period of time on the drug would be "indefinite," not a 12-week limit. This translates into increased revenue potential. And the company has supporting data to prove efficacy and safety over time, as they have over 100 patients with over 2 years exposure to Zenvia.
As mentioned above, Mike King of Wedbush compares the company to one that has a market cap of $1.5 billion. That number is above, but not far off from, my estimates. Cantor analyst says, "We think AVNR is significantly undervalued given its current market capitalization and near-term FDA approval potential for its lead product, Zenvia, to treat pseudobulbar affect plus potential value maximizing follow-on indications." Merriman analyst states, “The company’s market cap is significantly undervalued due to a previous regulatory delay and lack of knowledge of the PBA indication. In our view, the Phase III STAR trial data are compelling…”
Let’s examine a price/sales multiple. Cantor Fitzgerald estimates $675 million in peak sales for Zenvia, ramping up and seeing those peak sales in 2015. Personally, I think the estimate is a bit conservative when one factors the indefinite prescribed period and the other applications of Zenvia that should be approved following the PBA approval. But, let’s go with Cantor’s sales estimate. Although there is wide variation in price/sales ratios, the average biotech trades at 3 times peak sales. Since Avanir has rights to the drug longer than most drug companies (15 years), it could reach much higher multiples. But, even using a more conservative estimate of half that figure (1.5 times price/sales), the market cap of Avanir should be over $1 billion. That’s approximately $10 per share, indeed compelling with a potential upside of over 400%! And for more short-minded investors, there are two near-term catalysts:
A Barron’s article this weekend mentions that 9 pharma companies (Pfizer: PFE, Merck: MRK, Eli Lilly: LLY, Bristol Myers: BMY, Novartis: NVS, Roche: RHHBY.PK, AstraZeneca: AZN, Sanofi-Aventis: SNY, and Glaxo Smith Kline: GSK) are undervalued and could rally 30%, and
There should be a nice run prior to FDA acceptance, easily pushing the stock to $6. I’ve taken a sizable position and am quite ready to enjoy the ride!
Disclosure: Long AVNR, DNDN, PFE
going to go
L2 looks really good here. Bids are stacked
Huge buys coming in
ALXA-When is the offical change over on the Russell? Does any expect this to run during the change over?
STHG- One of the most popular searched on Google
One of the most popular stocks searched on Google finance!!!!!!!
This would bounce to .10 on a very little amount of buys. Still trades thin.
Still moves way too easy...buying pressure will run it up fast
There is no way the OS is 687 million. It moved way to fast low shares traded.
Why is this going up?
ALXA--Alexza Pharmaceuticals to Present at Jefferies 2010 Global Life Sciences Conference
Press Release Source: Alexza Pharmaceuticals, Inc. On Thursday June 3, 2010, 4:05 pm
MOUNTAIN VIEW, Calif., June 3 /PRNewswire-FirstCall/ -- Alexza Pharmaceuticals, Inc. (Nasdaq:ALXA - News) announced today that company President and CEO Thomas B. King will present during the Jefferies 2010 Global Life Sciences Conference. The Alexza presentation will be on Thursday, June 10, 2010 at 3:00 pm ET. The presentation will be webcast from the Grand Hyatt Hotel in New York, NY.
To access the presentation via the Web, please go to the Investor Relations tab at www.alexza.com or at http://www.wsw.com/webcast/jeff46/alxa/. A replay of the webcast will be made available approximately 24 hours after the live presentation and the replay will be archived for 14 days.
About Alexza Pharmaceuticals, Inc.
Alexza Pharmaceuticals is a pharmaceutical company focused on the research, development and commercialization of novel, proprietary products for the acute treatment of central nervous system conditions. Alexza's technology, the Staccato® system, vaporizes unformulated drug to form a condensation aerosol that, when inhaled, allows for rapid systemic drug delivery through deep lung inhalation. The drug is quickly absorbed through the lungs into the bloodstream, providing speed of therapeutic onset that is comparable to intravenous administration, but with greater ease, patient comfort and convenience.
AZ-004 (Staccato loxapine) is Alexza's lead program, which is being developed for the rapid treatment of agitation in schizophrenic or bipolar disorder patients. Alexza has completed and announced positive results from both of its AZ-004 Phase 3 clinical trials, submitted a New Drug Application in December 2009, and has a Prescription Drug User Fee Act (PDUFA) goal date of October 11, 2010. In February 2010, Alexza established a partnership with Biovail Laboratories International SRL, a subsidiary of Biovail Corporation, to develop and commercialize AZ-004 in the U.S. and Canada.
Alexza has completed an end-of-Phase 2 meeting with the FDA for AZ-001 (Staccato prochlorperazine) and has completed two Phase 2 studies with AZ-104 (Staccato loxapine, low-dose). Both product candidates are being developed for the acute treatment of migraine headache.
AZ-002 (Staccato alprazolam) has completed Phase 1 testing and one Phase 2a proof-of-concept clinical trial. Product candidates that have completed Phase 1 testing are AZ-003 (Staccato fentanyl) for the treatment of breakthrough pain, and AZ-007 (Staccato zaleplon) for the treatment of insomnia. More information, including this and past press releases from Alexza, is available online at www.alexza.com.
Safe Harbor Statement
The anticipated presentation will contain forward-looking statements that involve significant risks and uncertainties. Any statement describing the Company's expectations or beliefs is a forward-looking statement, as defined in the Private Securities Litigation Reform Act of 1995, and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of developing and commercializing drugs. The Company's forward-looking statements also involve assumptions that, if they prove incorrect, would cause its results to differ materially from those expressed or implied by such forward-looking statements. These and other risks concerning Alexza's business are described in additional detail in the Company's Annual Report on Form 10-K for the year ended December 31, 2009, and the Company's other Periodic and Current Reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and the Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
Anyone see any great values in Big Board stocks?
GNBT NEWS -Generex Biotechnology Announces Publication of Novel Immunotherapeutic Cancer Vaccine Results in Patients With Prostate Cancer
Press Release Source: Generex Biotechnology Corp. On Tuesday May 18, 2010, 10:04 am
WORCESTER, Mass., May 18, 2010 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (Nasdaq:GNBT - News) announced today publication of results from the first Phase I study of its lead immunotherapeutic agent AE37 in patients with prostate cancer. At the end of 2009, the Company announced positive interim results from a Phase II trial being conducted with AE37 in patients with breast cancer. The compound is being developed by its wholly-owned subsidiary, Antigen Express, Inc.
The report, entitled, "Results from a phase I clinical study of the novel Ii-Key/HER-2/neu(776-790) hybrid peptide vaccine in patients with prostate cancer," is being published (online publication date = May 13, 2010) in the journal Clinical Cancer Research, a journal of the American Association for Cancer Research whose focus is to publish innovative clinical and translational cancer research studies that bridge the laboratory and the clinic. The study extends previous observations demonstrating safety and immunological activity of AE37 in cancer patients. Interestingly, a decrease in the circulating levels of a fragment of the HER-2/neu protein was also observed in immunized patients. These results warrant a Phase II clinical study to establish the efficacy of AE37 in prostate cancer patients.
About Generex Biotechnology Corporation
Generex is engaged in the research, development and commercialization of drug delivery systems and technologies. Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity (with no deposit in the lungs). The Company's proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using the Company's proprietary RapidMist(TM) device. The Company's flagship product, buccal insulin (Generex Oral-lyn(TM)), which has been approved in India, Lebanon, Algeria, and Ecuador for the treatment of subjects with Type-1 and Type-2 diabetes, is in Phase III clinical trials at several sites around the world. Antigen Express, Inc. is a wholly owned subsidiary of Generex. The core platform technologies of Antigen Express comprise immunotherapeutics for the treatment of malignant, infectious, allergic, and autoimmune diseases. For more information, visit the Generex website at www.generex.com or the Antigen Express website at www.antigenexpress.com.
The Generex Biotechnology Corp. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=3831
Safe Harbor Statement
This release and oral statements made from time to time by Generex representatives in respect of the same subject matter may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plans," "intends," "believes," "will," "estimates," "forecasts," "projects," or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Generex cannot be sure when or if it will be permitted by regulatory agencies to undertake additional clinical trials or to commence any particular phase of clinical trials. Because of this, statements regarding the expected timing of clinical trials cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any "phase" of clinical trials. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.