December 20, 2011

Strategery (clarification)

"Unfortunately for patients, shareholders and management, the long history of safety of rose bengal, the stunning efficacy of PV-10 in the Phase 1 trial, and the reproducibility of results [from an interim look-back] in the Phase 2 trial, together with a change in regulatory perspective, were insufficient to sway the FDA to give PV-10 accelerated approval. With the benefit of hindsight and a suitable arms-length partner like Moffitt, the results of the two completed immuno-studies would have tipped the scale in management's favor. The cost? Likely 12 to 18 months.

The company now finds itself following its secondary path, which already was planned but now must be traversed."

A recent comment from a reader suggests I should have been more clear in my Strategery post. Thank you reader! The Strategery post was not meant to suggest a 12 to 18 month delay from the 3rd EOP2 meeting. I merely was commenting on the delay management suffered in trying to be smart, efficient and rapid in their pursuit of Accelerated Approval.

The secondary path always had been to pursue a Phase 3 trial suitable for an SPA. Like you, I believe they are on the cusp of agreeing with the FDA on an SPA at the 4th EOP2 meeting, which could occur as early as mid- to late-January, but more likely will occur around or before mid-February.

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