NWBO and FDA agreed that PFS was the primary endpoint. It is one of five endpoints that the FDA accepts in applications for approval. NWBO's interim trial analysis made it evident that DCVax-L wasn't going to meet the endpoint. And two weeks before the trial endpoint, NWBO knew they would fail the trial. They then totally redesigned the trial tossing out PFS primary endpoint. They changed the trial endpoints, comparators and even changed the sample of the trial (from naive patents to both naive and R/R). FDA clearly was not buying it or the NWBO certainly would have filed an application with FDA for U.S. Instead they went to UK which is virtually and unprofitable market for oncology personalized therapies. CAR-T has been a financial disaster and NICE took over 5 years to consider paying for it, and even then it was only through their charity and for only 100 patients a year at a deep discounted price for Gilead.
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