Earlier this year BioDelivery Sciences (BDSI) announced the completion of enrollment for its ongoing Phase III trial for BEMA Buprenorphine in the treatment of chronic pain, and the next logical step would be the completion of the trial itself.
That news hit the wires on Monday morning.
According to the press release, results from the trial should be released in mid-to-late September of this year, which would put the company on track to file a New Drug Application (NDA) for BEMA Bup in the first half of 2012.
The chronic pain market is a multi-billion dollar industry, and some projections have BEMA Bup reaching up to half a billion in sales annually, making the current market cap of this company look pretty weak for those that believe the lofty expectations can be achieved.
With REMS delays paralyzing the potential of ONSOLIS - BDSI's first product to market utilizing the BEMA drug delivery technology - there are high hopes placed on BEMA Bup, and it's a catalyst worth keeping an eye on as it could reinvigorate the long-time-sluggish BDSI share price.
That said, it is expected that ONSOLIS will also become a revenue factor later this year, once BioDelivery and commercial partner Meda finalize the ongoing REMS issues with the FDA. The amount of time that has elapsed since the companies first started negotiating the issue, however, brings to light the fact that sometimes the little guy doesn't seem to have much of a chance when dealing with the FDA; but then again, our elected government officials in Washington are proving daily of just how inept a city it really is, so what should we expect?
The inherent risk of this sector has hampered BDSI for long enough, after all, it's tough to predict years-long REMS issues, but the upcoming catalysts could be enough to breathe some life into this company once again.
Worth at least a watch-list.
Disclosure: Long BDSI.