Cobalis Corp. (fka CLSC)

[ScaryStocks]

Urche: This should answer your question. Prehistin will be over the counter...

Cobalis Corp. PreHistin(TM) Approval Process to Be Conducted by OTC Division of FDA
Thursday January 19, 8:00 am ET
FDA's Office of Nonprescription Products Will Now Handle Marketing Approval Process for Anti-Allergy Drug PreHistin(TM)

IRVINE, Calif., Jan. 19 /PRNewswire-FirstCall/ -- Cobalis Corp. (OTC Bulletin Board: CLSC - News), a pharmaceutical development company specializing in anti-allergy medications, announced today that the Company has been notified by the FDA that the marketing approval process (IND) for its anti-allergy product, PreHistin(TM), will now be conducted within the FDA by the Office of Nonprescription Products, the branch of the FDA which handles over-the-counter (OTC) drug products.

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The Company sees this as a positive development since, as an FDA-approved OTC drug, PreHistin(TM) would not require a doctor's prescription, thus making consumer purchases easier, faster and more convenient. Based on an extensive long-term history of safety, PreHistin(TM) has been intended to be an OTC product from its inception.

Typically, drugs that are approved for OTC marketing in the US are considered safe for consumers to purchase themselves, without requiring a physician's supervision. The market in the US for OTC allergy treatments exceeded $4.6 billion last year.

In regard to the drug approval process for PreHistin(TM), the FDA has also indicated to Cobalis that there is no distinction in the OTC environment between seasonal allergies and year-round allergies. The FDA has further indicated to the Company that it is likely that chronically allergic people would take PreHistin(TM) continuously. Thus, the anticipated indication would include both seasonal and perennial allergies which would increase the potential market for PreHistin(TM) to include not only seasonal allergies (such as hay fever), but year round allergies, such as cat, dog and other pet dander, dust mites, cockroaches and mold.

As previously announced, Cobalis has successfully completed the first of two required large-scale Phase III Clinical Trials, in which PreHistin(TM) demonstrated both clinical and statistical significance in a double-blind, placebo-controlled study of 714 allergy patients. The Company plans to engage the second Phase III Clinical Trial in the late spring of 2006.

Said Chas Radovich, CEO of Cobalis Corp.: "We are very pleased to report yet another major milestone with the news that the approval review for PreHistin(TM) is now officially in the hands of the OTC division at the FDA. Based on the extensive history of safe usage of cyanocobalamin, the primary ingredient of PreHistin(TM), we look forward to a smooth review process and to receiving OTC approval for PreHistin(TM)."

ABOUT COBALIS CORP. - PREHISTIN(TM)

Headquartered in Irvine, California, Cobalis Corp. is an over-the-counter, specialty pharmaceutical company. Its flagship product, PreHistin(TM) is currently in Phase III clinical trials and initial marketing in the U.S. will commence upon final FDA marketing approval. The U.S. anti-allergy medication market was $7.2 billion in 2003 and is expected to exceed $10 billion by 2010. PreHistin(TM), The World's First Pre-Histamine(TM), is currently in Phase III Clinical Trials in preparation for submission to the FDA to gain OTC approval for the allergy indication.

For further information please visit the website at http://www.cobalis.com