Replies to post #507728 on NorthWest Biotherapeutics Inc (NWBO)

[HyGro]

Read the post. The FDA statement is specific to the FDA and is in regards to the normal requirement that a drug needs TWO large-scale, well-controlled clinical trial.

NWBO doesn't have the time or the money for a second large-scale trial and is rolling the dice that the current Phase 3 trial is sufficient, even with all it's warts -- tossed out the failed original primary endpoint, tossed out the protocol/SAP and the questionable naive OS endpoint validity due to confounding of the OS data.

Whole lot of risk in an FDA application.