-- not be on other medications which would confound the data
-- not so advanced in their neuropathy that they are not capable of
Although the Company believes enrollment should be completed before year end 2007, based on the protocol and stringent criteria submitted to the FDA, it is difficult to predict exactly when the study will be completed.
Currently in the United States, there are approximately 20,000,000 people with Diabetes. Of this population, nearly one half have or will have the symptoms of Peripheral Neuropathy. The company believes that a safe and effective topical product approved by the FDA as a "first line" treatment for diabetic peripheral neuropathy could develop a significant market position in a growing therapeutic category currently dominated by systemic therapies.
The Quigley Corporation makes no representation that the US Food and Drug Administration or any other regulatory agency will allow this Investigational New Drug to be marketed. Furthermore, no claim is made that potential medicine discussed herein is safe, effective, or approved by the Food and Drug Administration. Additionally, data that demonstrates activity or effectiveness in animals or in vitro tests do not necessarily mean the formula test compound; referenced herein will be effective in humans. Safety and effectiveness in humans will have to be demonstrated by means of adequate and well-controlled clinical studies before the clinical significance of the formula test compound is known. Readers should carefully review the risk factors described in filings the Company files from time to time with the Securities and Exchange Commission.
About The Quigley Corporation
The Quigley Corporation (Nasdaq: QGLY, http://www.Quigleyco.com) is a
diversified natural health medical science company. Its Cold Remedy segment
is a leading marketer
|SOURCE The Quigley Corporation|
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