PREHISTIN
FREQUENTLY ASKED QUESTIONS
Following are some of the most frequently asked questions about PreHistin™.
Q: |
Is PreHistin™ available to consumers now? |
A: |
Cobalis is currently conducting Phase III Clinical Trials for PreHistin to obtain approval from the US FDA and other international regulatory agencies to market PreHistin™ for the prevention of seasonal and perennial allergies. These Clinical Trials commenced in the late 2004 airborne allergy season, and the Company hopes to commence consumer marketing of PreHistin™ in the US in the late 2007/ early 2008. |
Q: |
Will PreHistin™ require a prescription? |
A: |
PreHistin™ will be available as an Over-The-Counter (OTC) drug, and will not require a physician’s visit or a doctor’s prescription. The Company does urge serious allergy sufferers to see their physician to ensure a complete healthcare checkup. For consumers who take prescription allergy or asthma medications, the Company urges consumers to consult their physicians before discontinuing any prescription medications. |
Q: |
Can PreHistin™ be taken with other allergy medications? |
A: |
Yes. The active ingredient in PreHistin™ (cyanocobalamin) has been shown to be safe in over 50 years of use and scientific research, and there have been no reported negative drug interactions. However, consumers who take prescription medications for allergies or asthma are encouraged to consult their physicians before discontinuing any prescription medications. |
Q: |
Does PreHistin™ have any side effects? |
A: |
There have been virtually no side effects reported from the use or administration of the active ingredient in PreHistin™ (cobalamin). The Institute of Medicine reports that no adverse effects have been linked with excess vitamin B12 intake in healthy people (see: http://www.mayoclinic.com/
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Q: |
Is PreHistin™ safe for children? |
A: |
Although clinical studies specifically for pediatric dosing are not scheduled to be implemented until after PreHistin™ Phase III trials are completed for the primary indication of seasonal allergic rhinitis, cyanocobalamin is already approved by the US FDA as being safe for ages six years old and up. |
Q: |
What allergies are helped by PreHistin? |
A: |
Our initial Phase III clinical trials are being structured to gain marketing approval for the prevention and treatment of seasonal and perennial allergic rhinitis (hay fever). Based on both proprietary and independent research conducted to date we believe that cobalamin confers significant advantages for sufferers of year-round allergies to pollens, dust, mold, mites, pet dander and food allergies such as peanuts or shellfish. Subsequent studies will be conducted for indications for pediatric dosing and asthma, and other atopic diseases such as migraine headache. |
Q: |
Is PreHistin™ a cure for allergies? |
A: |
The term “allergy” means that you have a sensitivity (your body has developed antibodies) for a particular foreign substance or chemical (the allergen). PreHistin™ does not rid your body of these antibodies, but instead prevents the over-production of these antibodies when you are exposed to the allergen, and thus prevents the appearance of allergic symptoms. Thus, PreHistin™ is not a cure for allergies, but rather a preventative for allergic symptoms. |
Q: |
Will PreHistin™ be available only in the US? |
A: |
Cobalis’ plan for the marketing and distribution of PreHistin™ is global. Based on the most current estimates that 20%-25% of the total world population suffers from airborne allergies, we anticipate PreHistin to have widespread demand, capturing a significant share of the $18 billion global anti-allergy medication market. The timeline for launching within each country varies based on the individual required regulatory approval process, the dynamics of the marketplace and the overall roll-out plan coordination. |
For additional information, click here to contact Cobalis Corp.
Read PREHISTIN RESEARCH HISTORY
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