At first glance, this probably is the least communicative portion of the annual CEO letter, describing the company's regulatory progress in 2012. The explanation for the SPA taking longer than expected of "...oncology presents a moving playing field" feels unsatisfying. The use of "considering applying" in the context of breakthrough therapy designation being "...pivotal in achieving an accelerated path for approval of PV-10" seems curious.
Yet, upon further review, management's messages seem to be "Fine tuning of the study design is expected to mitigate clinical efficacy risk, optimize patient accrual, and increase FDA’s confidence that the study design and protocol will ensure the best possible outcome for our pivotal trial." and "Breakthrough Therapy Designation...could be pivotal in achieving an accelerated path for approval of PV-10."
In reading this portion of the letter, I am struck by two things. First, the closer to the regulatory perspective finish line, the less management may or will say. Perhaps that's why these paragraphs sound overly "lawyered." Second, it feels like this portion of the letter was written asynchrounously from other portions.