Investors following the science and trials, to date, can confidently see that bavituximab immunotherapy will 100% be approved by the FDA in the phase3 NSCLC trial that is now enrolling. Bavituximab’s excellent safety, shown after treating hundreds of patients, and the demonstrated efficacy of actually more than doubling survival in 2nd Line NSCLC, a deadly and difficult disease, leaves little to doubt that FDA approval is coming.
What has really just recently changed the equation for investors and the company is the awarding of the Fast Track designation for bavi by the FDA. These excellent accumulated data are really overwhelming.
Exactly how fast is Fast Track, we shall see. I expect it to come in the form of an Accelerated Approval, (AA) , early into the phase3 trial for 2nd Line NSCLC commercial approval.
When??? Hard to say, let’s watch! I think that we are just starting to break above radar.
IMO
sunstar