Replies to post #595888 on NorthWest Biotherapeutics Inc (NWBO)

[LessIsMore]

Their pipeline has nothing even close to BLA or NDA.

I don't disagree but the fact is that CMRX is at the White House today and your world-class management team is not.

It tells me all I need to know about NWBO's chances.

GLTY

[branster]

Crash, yea not sure how they heck they are front and center and not NWBIO....

Additional information on ONC201
In November 2021, we reported data from the 50-patient cohort for the treatment of recurrent H3 K27M-mutant diffuse midline glioma at the Society for Neuro-Oncology (SNO) annual meeting. Dual reader blinded independent central review (BICR) determined an overall response rate (ORR) of 20% by RANO HGG. The median duration of response was 11.2 months in addition to the 8.3-month median time to response. Disease control rate was 40% and progression free survival (PFS) at six months was 35% and at 12 months was 30%. In addition, by best response of either HGG or LGG the ORR was 30%.

ONC201 was well tolerated. Based on clinical trials, the most common adverse events were mild to moderate headache, fatigue, nausea and vomiting. The most common adverse event that was considered related to ONC201 was fatigue. More severe adverse events (Grade > 3) occurred in <10% of the study subjects, and the majority of these events were considered not related to ONC201.

The ACTION clinical trial study planned for 4Q22 is a randomized, double-blind, placebo-controlled in newly diagnosed diffuse glioma patients whose tumor harbors an H3 K27M-mutation. The primary endpoint of the study is overall survival (OS) with alpha allocation to progression-free survival (PFS). The study will take place at up to 120 sites in North America, Europe and Asia Pacific.