NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

First a few points
1. SurVaxM is given as an injection in the arm after the patient has had surgery and completed radiation treatments.
2. The mOS for the DCVAXL trial was 22.4 months from surgery and 19.3 from randomization.
The Roswell Park’s SurVaxM trial median overall survival was 25.9 months, measured from the first dose of SurVaxM
3. In the DCVAXL trial it took 3 weeks on average (if I'm correct) from surgery to the first dose. Therefore to compare the two
its 22.4 months + 3 weeks = 23.25 mOS vs 25.9 months, DCVAXL is still underperforming by about 3.7 months
4. However since SurVaxM is not personalized there is no need to wait for personalized production and therefore it will be much cheaper and faster to administer than DCVAXL even with Eden in place

Both results are surpassed by the Keytruda combo trial with DCVax-L and Poly ICLC.

Yes DCVax-L and Poly ICLC + Keytruda may very well provide much better results however NWBO may have to run a phase 3 trial to prove they offer better results IF the FDA remains stubborn and unreasonable in demanding individual patient data level