NorthWest Biotherapeutics Inc (NWBO)

[Dan88]

Pure nonsense!

With an outdated/obsolete SAP, how data should and can be analyzed after initially-intended events had been reached?

CEO has said persistently and repeatedly the trial will not stop at interim -- thus there was not any interim analysis taking place except the 66-event safety look in 2014 (trail expansion), and the company hinted and has demonstrated they are aiming at long-tail (milestone survivals of 3 ~ 5 years hard data (not derivative).

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.