In three Phase 1 and 2a clinical trials, there have been no drug related adverse events. Between 2008 and 2010 2.5 million doses of the compound were sold through doctors and dentists offices with adverse event tracking. There were no drug related adverse events. US FDA demanded a halt of sales not due to side effects, which they have none reported, but due to considering the compound being a New Chemical Entity (NCE) needing to go through a drug development program before it could again be available, as a drug. That usually takes about 10 years and we are on schedule.
