Replies to post #645479 on NorthWest Biotherapeutics Inc (NWBO)

[alphapuppy]

As I recall, the primary endpoint for the original trial prior to any changes was overall survival. Not PFS. A prior trial using only four antigens from IMUC was negative on PFS back and I think 2013 or 2014. so I don’t know why everybody is making such a big deal about the PFS when it wasn’t even the primary endpoint of the original study. They’re like saying it is when it wasn’t. The significance of pseudo progression cannot be overstated, especially in those early years when things could get coded as progression when they really weren’t, that’s why overall survival is so important overall survival is the gold standard. Just my two cents.

[learningcurve2020]

How many times did I mention hemisphere here over the years with all the hand waving.


>>The DCVax-L trial was limited to patients with tumors in one hemisphere,

>>Patients with progression at the completion of radiotherapy were excluded. These are high level inclusion criteria, aiming at enrolling a select group of patients with very favorable clinical characteristics assumed necessary to show efficacy of the vaccine strategy—but also likely to be associated with improved OS.

>>These data show the huge impact of residual enhancement at the time of progression, which is also present in the DCVax-L trial resulting in a 3 months difference in OS between minimal and significant residual disease using a similar definition

>>of the 5 newly diagnosed glioblastoma trials used for comparison no attempt was made to control for residual tumor volume.

[learningcurve2020]

Have to get to the bottom of it:

>>This brings me to another point. What the heck are they spending money on exactly? Look at their 10-K, they spent $89.5 million the last three years on R&D. This for a company that wasn’t enrolling their Phase 3 trial for several years and doesn’t seem to have any other trials going on.

>>Their G&A spend is another issue, as they have spent $121 million over the same period. This is a company with 22 full time employees.