Agree with below. NWBO has been in constant contact and regulators are aware of the proposed rewrite topics and plan for looking at pseudoprogression and long tail especially.
There are tense negotiations behind the scene between the company and FDA, and other three RAs.
To be able to appropriately and effectively analyze trial data, a new SAP is necessary, and we were nearing completion of the SAP at the time of ASCO.
Mind you the trial is adaptive; the advancement and progresses achieved in the past decades in immunotherapical treatment of GBM have called for a new mindset and a whole new full set of parameters.
Definitely FDA is well aware of that, so are other RAs.