Replies to post #571373 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Tell that to Dr. Steven Brem, U Penn:

I seriously doubt they think an unrelated 11 patient P1 that does not use DCVax-L is going to help DCvax-L get approved for all indications.

But if you want to argue that other DC vaccines somehow relate to DCVax-L, what about all the failed DC vaccine trials?

[TTsr]

Thanks BI!!! Sky is the limit… here are Brem quotes from Twitter:

“Key points of the Lepski et al. study: i) GDC - Genomic Data Commons as an external control population; ii) OS 75% greater in vaccinated GBM group (82% RRR-relative reduction in risk- of death at any timepoint); iii) 200% greater OS in the vaccinated astrocytoma 4 group (47% RRR)

In addition, the all-important "tail" of the survival curves, 7/37 patients (5/7 GBM) were still alive at the time of publication. Long-term survivorship, and the other data, support the continued development of dendritic cell vaccines in the treatment of high-grade gliomas.”

So I asked this previously… with #s like these, and a excellent safety profile, do you all think the FDA will require lengthy P3 trials before approving DCVAX to treat these needy patients?