Carboat, read them, certainly the one that has been posted here because it even talks about the provisions, the sub groups and the pro active inclusion in the FDA protocol.
If PPHM can find a sub-group in Sunrise where Bavi + docetaxal appeared highly efficacious, and I highly doubt that would be the case since the trial was stopped so soon, it will NOT be the basis for a BLA submission let alone FDA approval. The best PPHM could hope for would be to start a new trial to test out whether that subgroup link is real. If PPHM were smart, and they haven't been yet, that would involve a new phase II first since PPHM is cash strapped, not a phase III.