NorthWest Biotherapeutics Inc (NWBO)

[HyGro]

Let's see, first NWBO chose PFS as their primary endpoint. Dr. Liau, the lead clinician, reconfirmed PFS as the primary endpoint again in her 2018 journal publication. Also outlined the process to deal with pseudo-progression. Then NWBO failed to meet the PFS primary endpoint and suddenly NWBO redid the whole trial.

Dr. Liau chose PFS as the lead efficacy endpoint for the NCI SPORE Keytruda combination trial. She seems ok with it as does NCI and Merck, the leader in oncology treatment revenue having done dozens and dozens of oncology trials.

FDA accepts PFS as one of the 6 tumor cancer endpoints for approval consideration. If you reviewed any of the ASCO clinical data presentations many used PFS. Dismiss it all you want. but PFS is a valid endpoint -- except if you are NWBO and you fail to meet you primary endpoint.

And NWBO has repeatedly reported that the naive OS data was confounded which raises questions as to the validity of the data It is certainly not "gold standard" when the data is confounded. Don't hear NWBO report that in their TLD presentation did you?? It's just buried on page 16 of their SEC 10K filing.