NorthWest Biotherapeutics Inc (NWBO)

[VMLG17]

Hi Pyr, A question from someone new to biotech and the FDA's clinical trials:
As you well know from clinicaltrials.gov, the DCVax-Direct Ph I/II trial design has been designed as follows:
? Primary Outcome Measure.: Adverse events (6 months) ~ safety.
? Secondary Outcome Measure: Tumor Response (18 months) ~ sum of partial and complete responses.
? Other Outcome Measures: # of Patients Surviving AND # of Patients Surviving w/o Tumor Progression (24 months).
If phase II trial results related to the secondary outcome measurement involving ORR and RECIST are borderline or fall short (your recent concerns) but are adaquate related to one of the other outcome measures, is it likely that NWBO will receive the go ahead for Phase III anyway?
Thank you.