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I bought $BDSI.. Chart with basic DD

BDSI is such a compelling prospect for a short term investment for a couple of different reasons.  The most important reason being a major catalyst coming mid 2013.  BDSI is anticipating a mid-year filing of an NDA for BUNAVAIL(tm) for the treatment of opioid abuse and addiction.  BUNAVAIL is BUPRENORPHINE combined with NAXALONE formulated with it patented BioErodible MucoAdhesive film.  It will be prescribed to patients who are addicted to opiods such as MORPHINE, HYDROCODONE and OXYCODONE.  According to the 2010 National Survey on Drug Use and Health, conducted by the US Department of Health and Human Services, more than 2 million people are addicted to prescription opioids.  Let me give you an idea of what type of market exists for the company and this type of therapy.  There is only one other BUPRENORPHINE/NAXALONE film marketed for this type of indication, owned and marketed by RECKITT BENCKISER.  According to Wolters Kluwer, US sales of SUBOXONE(tm) Film exceeded $1.5 Billion in 2012.  BDSI claims they can easily grab a $300 chunk of that market which I believe is on the modest side.  SUBOXONE Tablets just came off the market late last year, leaving SUBOXONE FILM the only therapy of its kind on the market for opioid dependance.   (from BDSI website


From BDSI 10-K


In September of 2012 BDSI announced positive data on on their Pivotal Pharmacokinetic Phase III study of BNX (BUNAVAIL).  Then is JAN 22 the company released data from a safety study evaluating the safety and tolerability of the drug.  249 patients were switched from SUBOXONE to BNX in the study.  The study proved that the drug was easy to use and well tolerated in patients.  The study also proved that doctors could easily switch their opioid dependant patients over to BNX from SUBOXONE with no difficulty whatsoever.  There no adverse advents in the study.  More detailed results are planned to be released in the very near future.  If BNX gets approval, it will be the only film Bup/Naloxone product to directly compete with SUBOXONE.  BDSI has stated that the company is open for discussion with possibilites as to with commercialization and partnership of the product here in the US or in the EU or both.

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