NorthWest Biotherapeutics Inc (NWBO)

[Dan88]

Excellent comments from a pro. Just add the following for both newbies and fudsters to ponder:

For the current standards of care:

Almost all patients experience tumor progression with nearly universal mortality and a median survival of less than 15 months from surgery, with a 2-year survival rate of 26–33%. To date, no new agents improve survival when added to standard therapy.

[source: https://www.ncbi.nlm.nih.gov/books/NBK469987/]

For the current DCVax-L P3 trial for GBM:

Population n Median OS since surgery Survival at 1 year Survival at 2 years Survival at 3 years
2017 data 331 23.1 months 89.3% 46.2% 25.4%
2018 data 331 23.1 months 89.3% 46.4% 28.2

[see as time goes by, the trend is that the OS has improved]

more detailed breakdown:

Data set n Median OS since surgery Survival at 1 year Survival at 2 years Survival at 3 years
2017 methylated 131 34.7 months 94.5% 66.7% 46.4%
2018 methylated 131 35.1 months 94.6% 66.6% 49.1%
2017 unmethylated 162 19.8 months 86.4% 32.1% 11.0%
2018 unmethylated 162 19.8 months 86.4% 32.6% 14.3

[source: https://nwbio.com/update-on-dc-vax-at-asco-2019/]

[Based on what we have know today as fact shown above, the odds of DCVax-L gained approved by FDA is substantially high (> 80%)]

Then, there is the current evolution version of FDA: Demonstrating Substantial Evidence of Effectiveness for Human Drug and
Biological Products Guidance for Industry -- https://www.fda.gov/media/133660/download]

and there is WHO's updated GBM definition which is highly in favor of DCVax-L's approval.

Finally, the principle for FDA to approve a new agent has always been the assessment of benefit-risk of the underlying agent. For DCVax-L, we know as fact it's safe almost without any side effects, so as long as nwbo can show concrete evidence that the vaccine is efficacious in treatment GBM, no regulatory agencies can deny its approval [a bit of rhetoric].