Pleas don't add your thoughts into a legal document from the FDA, The denial is clear.on the scam, Certainly anyone should read and come to their own conclusions. Why haven't the fraudsters re-applied as a drug? That will NEVER happen, IR phoney spin would say not interested any longer in the US market, too expensive to apply or some other scam babble. The did have money for the stock promotions and press releases (misleading ones). None for auditors, none for real FDA scrutiny.