Bioelectronics Corp (BIEL)

[srinsocal]

So let me get this logic right...when the FDA looked at the Clinical Trial Data for the Knee, Foot, and Eyelid Surgery and said, ActiPatch is Safe and Effective, and gave 510k Clearance, they must have been Wrong???

Japan is an expensive market to enter. Japan did not, "through it back at them and asked them to leave their country". The party with the distribution rights for Japan did not have the financial resources to enter the market.

It cost $10k for a 2 hour meeting with the PMDA regulatory agency in Japan and $107k to register a medical device. This is after you have paid tens of thousands of dollars to a DMAH/MAH, an in country representative for your product. You also still need the services a distributor.

ActiPatch successfully entered the Medical Device Markets of the United Kingdom, Australia, Germany, Sweden, Italy, Spain and a dozen other countries.

The "flimsy POS" is solely the opinion of an anonymous message board poster not Japan or the US FDA who has Cleared the ActiPatch for 3 Indications.