numerous cumulative trials show bavi to have stunningly few AEs. that is well known... i wouldn't read too much in to the few bleeding events in the P2 in attributing them to pphm's drug.
many people noticed placebo arm had more bleeding events than 1 mg arm which was odd. Later the company said placebo arm and 1 mg arm were mixed up
I've often questioned Bavituximab's effectiveness and inability to produce measurable biomarker-ism. However, as events occurred, specifically Coagulant Interventive Contribution (CIC), or bleeding as a result of PS cloaking, which has theoretically discredited the placebo misnomer, and oxymoronic "hat hanging". After all, this is Bavi's, "I'm here" signal, and reasonable proof for advancement.
There is little doubt that Phosphatidylserine plays a specific role in immunosuppression, coagulation, apoptosis and immune editing. The premise that Bavituximab is cloaking to any of these phenomenon is intriguing, and worthy of trial. The FDA agrees...
Don't discredit an undoubtably useful imaging agent, and immunocojugate. That's a different billion dollars, IMO..