That was one of a few weird parts of the conference call... declining an SPA from the FDA???
I thought the whole process involves a company petitioning the FDA to allow a SPA, then there is negotiations, and an SPA is agreed to. Weird. Perhaps there was something the FDA demanded to be part of the SPA... related to biomarker--CA125, or efficacy analysis, or maybe VBLT wanted two arms.... VB-111 versus standard of care to avoid some of the problems involving the GLOBES trial where patients at first dropped out after being assigned to the Avastin arm.
To be perfectly candid, I'm a bit more uneasy after this call regarding VBLT regarding the interim based on how the manufacturing facility for VB-111 will open in the second half, the ovarian trial(results were known from the phase II a year ago) will start late in second half with the checkpoint plus VB-111 trial will begin end of year and after next year.
My point... it looks like a lot of VB-111 activity will commence after VB-111 passes the interim analysis. There could be a real fear of passing the futility hurdle in the interim analysis. If VB-111 fails to pass futility one can readily envision dropping the manufacturing facility, canceling the ovarian cancer trial(the whole SPA issue is weird beyond almost any rationale).
I can see, should VB-111 not pass futility, you will see the company focusing all available monies on the VB600 series and trying to partner for NASH.
