From quarterly PR dated December 2012...
This was what management dangled before us after the bungled Bavi lung phase ll trial:
"Certainly the recent highlight for Peregrine is the agreement reached with the FDA that provides a clear pathway for advancing our Cotara program into a pivotal registration trial in patients with brain cancer. This milestone is the result of a significant amount of work and collaboration with the FDA of which we are particularly proud given the potential for this novel treatment in this difficult to treat disease," said Steven W. King, president and chief executive officer of Peregrine. "This was also a very strong quarter for our manufacturing subsidiary, Avid Bioservices, as we are on track for another record year of manufacturing revenues. We are also making steady progress in advancing the bavituximab program on multiple clinical fronts with important clinical milestones anticipated to occur over the coming months. Upcoming clinical milestones for the program include key median overall survival endpoints in pancreatic and front-line non-small cell lung cancer and final results from our second-line non-small cell lung cancer study in which we discovered discrepancies and have subsequently been intensely reviewing. The goal of this review is to be able to generate a final data set that we believe could be used to support advancing the program into a pivotal trial."
COTARA PROGRAM HIGHLIGHTS
Peregrine announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on the design of a single registration trial for Cotara in patients with recurrent glioblastoma multiforme (GBM) following an end-of-Phase II meeting. The FDA has agreed with the company's proposed randomized trial design evaluating two dose levels of Cotara in up to 300 patients. The trial design allows for multiple interim data analyses with the potential to stop patient accrual early based on predicted success or futility. The company plans to seek partners both in the U.S. and internationally to support the development of Cotara for this deadly form of brain cancer. Cotara has been granted orphan drug status and Fast Track designation for the treatment of GBM and anaplastic astrocytoma by the FDA and orphan drug designation by the European Medicines Agency (EMA)."
Makes you wonder what the heck???
Jmo
Loofman
