EDMONTON CV Technologies Inc. plans new clinical testing of its Cold-fX product, aiming to sell it over the counter in the United States.
Cold-fX, which uses hockey commentator Don Cherry in advertising and describes itself as Canada's best-selling cold and flu remedy, said Monday it will seek U.S. Food and Drug Administration approval to sell the product over the counter “for the prevention or reduction of the risk of cold and flu.”
To obtain this approval, CV Technologies intends to conduct Phase 3 drug trials, said CEO and chief scientific officer Jacqueline Shan.
Dr. Shan estimated the process will take at least three years and cost between $20-million and $30-million.
In the meantime, the company is seeking FDA approval to sell Cold-fX categorized as a new dietary ingredient and it “will continue to concentrate its efforts on maximizing market penetration in Quebec and other parts of Eastern Canada.”
CV Technologies also plans to strengthen and advance its research and clinical programs to add “support to existing product claims” that ginseng-based Cold-fX works by strengthening the immune system.
Monday's announcement followed what the company characterized as a “misleading and inaccurate” article by a senior business reporter for the Vancouver Sun, which was also published in other CanWest MediaWorks newspapers and raised doubts about CV's claims.
CV said in a statement it “continues to stand behind its motto, Trust the Science — science, in the form of a talented team of medical experts, seven clinical trials and peer-reviewed publications.”
The Sun article “contains errors, misleading information, improper context, unfamiliarity with cold and flu clinical research, and a pharmaceutical predisposition to curative care rather than preventative care,” stated Dr. Shan, who uses the honorific Dr. to signify doctorates in physiology from the University of Alberta and pharmacology from a Beijing college.
“Cold-fX works and we can prove it.”
In its latest reported quarter, Edmonton-based CV Technologies Inc. had October-December sales of $18.9-million, up 68 per cent from a year earlier, with a 76 per cent increase in pre-tax earnings to $7.4-million.
© The Globe and Mail
Only GlobeinvestorGOLD combines the strength of powerful investing tools with the insight of The Globe and Mail.
Discover a wealth of investment information and and exclusive features.