Replies to post #234479 on NorthWest Biotherapeutics Inc (NWBO)

[trocprofit]

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.

[iclight]

How many quotes from LP about the 2015 interim efficacy analysis do you need to see to realize there was in fact an interim efficacy analysis?

And again, modifying an SAP doesn't take years like LP claims. But hey, keep up your fantasy scenario if it's the only way you can justify your huge losses.

[exwannabe]

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),

Pure nonsense!

She reportedly said one time, at the Dec 2014 ASM, that the trial would not stop early.

She said publicly Jan 12, 2015 that there would be an efficacy IA later in the year. She has never walked back that statement.