sure, this is from my notes:
phase 3 adjunct - patient req. 15 on pro140, 15 placebo = 30 total
should have all patients by end of year and done with trial 1st quarter 2017. FDA requires a safty study but that will include data from patients already injected, patients in phase 3 adjunct and patients that will be in the phase 3 mono therapy. looks like the FDA did not give a # of patients required - just that they prove the safety of pro140.
also, the determination of a successful trial was loosened up - the amount of viral load reduction and the number of patients with successful response. it looks like the FDA is mostly interested in seeing the pro140 patients show a significant VR reduction over the placebo group.
the phase 3 mono trial looks like it is ready for final submission to the FDA so that trial can start enrolling also. FDA is not requiring a control group for that trial which is significant. no real timeline given for the p3 mono but it looks like the enrollment will be finished quickly. i was given the impression the enrollment has been held up by getting the final protocol agreed on, not on a lack of patients wanting to get in the trials.
most of the Q&A was about the trial details, i was one of the few who asked about the stock price. a rep. from paulson asked about the plan for commercializing after approval and Nader seemed to me very clear a partnership or buyout is the plan. Nader said that he can't comment on who or if they are in talks but said the door is open.
Nader did also say they have interviewed 9 of the 10 patients in the p2b trial. the patients report that there way of life is dramtically better - not feeling sick, able to work etc.. very impressive results.
