The FDA decision to (dis)approve the SAP will determine which endpoints will be evaluated. Only in a very few cases the FDA approves a drug when it fails the primary endpoint and in such cases the name of such companies sound like GSK, AstraZeneca, ...
IMO the FDA will approve the SAP -otherwise I would not be holding shares of NWBO -because the FDA in the first instance approved the crossover protocol. Now that 90% of all participants received DCVAX-L, from which there are about >67% of all crossover placebo patients, the FDA has no other option to agree to take an other endpoint as primary endpoint to determine the effectiveness of DCVax-L (statistical difference of 30 placebo patients vs DCVax-L patients is too low).
It is now upto the FDA and NWBO’s biostatisticians to determine the SOC OS and PFS surivival from historical data and determine which number of extra months must be archieved as a minimum to get statistical significance (p<0.05). Most important should be OS.
If they can show mOS is statistical significant better than placebo, we make a home run.
If they can show a survival tail of +5 years in >15% respondents AND/OR longer survival at recurrent GBM the sky is the limit.