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Replies to post #146958 on Biotech Values
08/11/12 7:40 PM
09/10/12 4:54 PM
Excellent point. To date, the adverse-event profile of Bavituximab is more consistent with its being a placebo than the highly active agent in such disparate diseases as HCV, HIV, and multiple forms of cancer that the company’s management would have investors believe.
As you have just heard from Joe, the data we announced last week has far exceeded our expectations. And I hope that you're as excited as I am with bavituximab's potential. I feel strongly that Peregrine should be recognized for having the corporate courage to conduct the rigorous, randomized placebo-controlled Phase II trial that provided these robust data and that provide the basis for us to plan for a pivotal Phase III program. We took extraordinary amount of care in developing this Phase II trial design and conferred with clinical experts and regulatory agencies, including the FDA, in design of this rigorous clinical trial. Peregrine chose to conduct this trial to definitively establish the proof of concept to bavituximab and now plan to potentially include this data as part of a registrational package.Having personally been involved in the evaluation of over 30 Phase II trials over my career, none of which ever achieved statistical significance, including many of today's blockbuster biotech products; I am personally extremely pleased with the quality of this data and the clarity with respect to advancing bavituximab in Phase III trials, which it provides.
Our next steps are to present the data you saw last week to global regulatory authorities as part of the formal end of Phase II meetings from which we anticipate gaining concurrence into the planning and execution of a pivotal trial program. Normally, it takes approximately 60 days to arrange such end of Phase II meetings and following these meetings to submit IND amendments for the Phase III and initiate the trial by mid-2013.
AI
