It's been about, what, two years now since the FDA approved BioDelivery's treatment for cancer pain, ONSOLIS?
And two years later the company is still awaiting a final decision from the FDA regarding the REMS issue which has limited the market potential of the company's flagship product.
According to a press release issued Thursday, BioDelivery confirmed that its marketing partner Meda has filed the modified REMS with the FDA in December of 2010, meaning that if the FDA stuck to its self-imposed time frame for review (although we know that the FDA is never bound to their own guidance or timelines), then a decision should be forthcoming sooner, rather than later.
The following statement from the press release sums it up in a nutshell:
"While we anticipated this review would be completed by this time, we are working diligently with our partner Meda and the FDA on the few remaining components that we believe will allow for the final approval of the modified REMS program sometime this summer. Given this final approval is dependent largely on the FDA's constraints, we cannot be any more precise regarding the exact timing for ultimate approval."
In other words, the FDA is late in rendering a decision, but the administration is not really late because its guidelines are merely suggestions, and more often than not, the little guy gets thrown to the bottom of the pile.
The FDA's ineptitude should come as no surprise. After all, it is a federal agency in Washington, where 'inept' is the word of the day, every day.
Once the issue is resolved - if it's ever reviewed - then a positive outcome could provide a spark to the otherwise dull BDSI trading pattern over the past couple of years.
Still worth watching, and still worth accumulating, in my opinion, with an eye towards the long term.
Disclosure: Long BDSI.
