An FDA mandated AdCom can oft times be be a propitious event. The outcome(s) of AdCom findings findings can serve as the predicates for other administrative actions.
Specifically, one possible outcome could be a recommendation for Remoxy's approval AND Oxycontin's removal from the market (see the recent LATimes extensive investigative reporting regarding Purdue's "fraudulent" Oxycontin 12-hour release marketing claims).
The pivotal issue here will be the demonstrable superiority of Remoxy as a "true" 12-hour release drug. Claims of "superior" abuse resistance qualities fall more into the realm of the subjective and are less likely to be decisive in any deliberations to recommend Oxycontins removal from the market.
All of the above is perhaps wishful thinking, but stranger things have been known to happen in the past.
All facts and circumstances would seem to indicate that Remoxy (at long last!) will be approved. Moreover, Remoxy's market launch coincides with an avalanche of negative publicity (see LA Times investigative reporting) regarding Purdue's OxyContin and spurious (false) time release marketing claims. PTIE's Barbier has in the past implied that Remoxy's "true" 12-hour release mechanism (plus superior tamper/abuse resistance qualities) could knock OxyContin off the market. Maybe so...maybe not. My point is that DRRX's potential future royalty revenue stream could be significantly greater than that flowing from just another "me too" drug. This asset ,too, could be monetized (avoiding further dilution) for an amount that Remoxy's tortured path to market launch would never before have suggested possible.
No doubt that DRRX has been to this point the proverbial "gang that can't shoot straight". However, do not discount the significance of insider buying. As regards Remoxy, it was returned by PFE to PTIE not because of doubts as to efficacy (and ultimate FDA approval) but because of an uneconomical royalty structure AND because Remoxy would have materially cannibalized sales of PFE's in-house abuse-deterrent ER drug candidate.
DRRX sells 13.8million shares at $1.25 ($17,250,000 gross proceeds) and the share price goes up BEFORE the offering is a fait accompli? Thus defying all logic?
Not really. DRRX now has the cash (and the time) to fund and robustly execute what is hopefully the final Posimir Phase III AND to negotiate an optimal partnering agreement. (I do not believe a go-it-alone marketing strategy is or should be in the equation.) Adequate funds are now also at hand to fully fund on-going, early stage DUR-928 clinical trials.The financing transaction is also a bridge to the royalty revenue stream from Remoxy's approval and market launch in Q4 of this year. "Good" dilution is about as rare as a unicorn.
I think we all should take a deep breath and stop hyperventilating over the FDA's recent amicus curiae advisory to DRRX regarding Posismir. The outcome likely will be a more robust Phase III resubmission package, a greater probability of approval, more expansive labeling and enhanced third party partnering prospects. More time and money, yes...but, all facts and circumstances considered, not a bad prospective outcome.