BioDelivery Sciences International, Inc. (NASDAQ:BDSI)

BioDelivery did some pretty significant damage to my brokerage account and my CAPS score. I can't do much about the former, but I can strive for some redemption in the latter. BEMA buprenorphine is a clinical failure and BEMA Fentanyl is a commercial failure. The last man standing would appear to be BEMA buprenorphine/naloxone, headed for a pivotal comparative pharmacokinetic study versus Suboxone. It's hard to say what exactly a pivotal comparative pharmacokinetic study is, except that it seems to be a way for the company to circumvent a direct clinical efficacy comparison study with Suboxone.

BioDelivery thinks the FDA is cool with that, but they're going to take the prudent step of meeting with them before initiating the study. Based on BioDelivery's prior accomplishments, I wouldn't put much stock in their prediction of the FDA's mindset. This is hopefully a short-term green thumb on a deep dip, eventually to be followed by a red thumb to bankruptcy.

Recently really beaten down by the failure of early phase 3 clinical trial results showing its pain drug BEMA Buprenorphine missed the primary target of its study, but Buprenorphine is already a Food and Drug Administration-approved drug for pain treatment. BDSI has $21 million in cash so a revised study is underway. Good company, well run, hit a bump in the road.