RS
How should the market have reacted ?
Has Mr Simes provided the path forward for new efficacy trials ? Did the request using P & G or 505a results to either waive new Efficscy trials or reduce the size required ?
Let's assume FDA would allow all or part and Bpax released news of same along with final 9 th review ??? He pps would have skyrocketed ,
Mr Simes said they would meet with FDA and explore all poss ave , that was several months ago,
Why did bpax decide not to meet with FDA ? Our they did what was the outcome of that meeting ?
Did the FDA reject using other data ? If so say it !!!
If not why did the not ask !
All valid questions that need answers, prior to voting
Ty Jmho