NorthWest Biotherapeutics Inc (NWBO)

[HyGro]

Dr. Liau confirmed the PFS measure in 2018 and even identified that they had a new method to distinguish pseudo-progression. From her paper:

"PFS has not yet been evaluated for this publication and will be the subject of later analyses to allow for central, multi-factorial assessment by an expert panel, using criteria currently emerging as appropriate for immune therapy in this patient population where progression can be complex to determine and pseudo-progression is a known confounding phenomenon."

And Dr. Liau is using PFS as the lead efficacy endpoint for the SPORE GBM combination trial (PDl-1/ATL) with immunotherapy that was recently started.

NWBO has not made ANY statement as to the cause of the trial stoppage. FDA stops trials for SAFETY issues not for confounding -- that is settled post trial.

Placebo is safe too, the issue is does the trial show valid efficacy results or not.