RE: RE: Patent absolutely necessary prior to launc From their March 6th press release
Miraculins can begin to market the PreVu test in the U.S. after registering with the FDA as a device establishment, and after PreVu is listed as a device under Miraculins. This step is strictly administrative and is being timed to coincide with the finalization of the Company’s U.S. sales and marketing launch strategy and the preparation of all related support materials and product labeling, including a web site being built exclusively for the U.S. marketplace. By registering and listing, Miraculins will be informing the FDA that commercial distribution has commenced. Miraculins has indicated it plans to register shortly and will update the market accordingly on its specific U.S. launch plans at that time.