Ann: Update on Phase 2 Trial and IND Progress, page-40

Redcordial,

You're missing the point. Why would you want to trial BIT225 with Harvoni? You wouldn't be able to statistically determine which drug is reducing the viral load. The only reason you'd want to trial both together is for drug-drug interaction studies. To really determine the efficacy of BIT225 you would want to trial it in isolation to any other HCV treatment. But doing this is very hard, if not impossible to get regulatory approval.

I think you guys are getting confused with what a clinical trial is supposed to show. Clinical trials are there to demonstrate the efficacy of your candidate drug against a baseline. If your baseline already has a >90% success rate, it makes it really hard to determine statistical significance for the test drug. Comprehend? Stop getting obsessed about comparison to state of the art SOC. It's not about that. For regulatory/ethical requirements, clinical trials use the current SOC in conjuction with the candidate drug because it's very hard to get approval otherwise. Biotron is lucky that they got their trials in before the bar was raised on SOC.

Put it this way. If you had a treatment that was 100% effective, with 0% adverse reports and that was the SOC. Why would you bother putting up a new candidate for trial? You wouldn't.

Admittedly this puts BIT225 in a difficult position as J8 has mentioned before. Given the current success of these treatments is there any need for BIT225 in the market? Is there a niche market? Does a big pharma give a toss? We don't know. And it piles big expectations on the release of the latest results.