I have a hunch that European patent I posted a link to yesterday is a key piece for BMOD to speed things up here. Going right to Europe and use the dual roads to approval of US and Europe.
We are also developing strategies to enter the European market, including filing for approval of a CE mark.
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Here was CEO talking about Europe versus US.
BB: With 90 million smokers in the U.S. and 215 million in Europe, are you focusing more on one group or the other?
JJC: Had you asked me that six months ago, I would have told you our focus was on the U.S. market, but right now we are headed down parallel paths. Initially, we were going after FDA approvals in the United States, and we still are. But, within the last six weeks or so, I was contacted by the National Horizon Service, which is part of the National Health Service in the U.K. The National Horizon Service seeks to identify promising technologies, therapies, and diagnostics which are on the horizon and which may soon be integrated into the U.K. health system. And the NHS contacted us to inquire about the availability of our assay in the U.K. That precipitated us to contact Quintiles Transnational Corp., our regulatory consultants in the U.S., who put us in touch with Quintiles Europe, who is now putting together our CE Mark dossier. In addition, Quintiles Europe is doing a market access study with the “Big 5? countries, the U.K., France, Germany, Italy, and Spain and with 10 or so of the smaller countries, to see where it might be best to introduce our technology. So, with our market access study in Europe and our FDA approvals in the U.S., we are aggressively moving forward on parallel paths.
AI
