NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

First, it is a clinical hold (at least in the US). Not a halt or partial halt. The FDA issued hold was only partial, that is true. But still a hold. Straight from NWBO:

NW Bio Announces Lifting of Clinical Hold on DCVax®-L Phase III Trial By FDA; Progression-Free Survival Events Reached; Overall Survival Events Not Yet Reached

Back to the meat of the issue.

Most all agree it was not a safety issue (though longfellow has suggested the possibility that the actual placebo caused damage as it is active).

On the "damaged by not getting the drug" theory, that is efficacy. But the FDA makes clear that they do not make the call on early efficacy terminations, the sponsor does.

Further, how would the FDA even know if the DSMB had not performed an efficacy IA? They do not generally peek into trials unless they are alerted to a safety issue. The rare exceptions they mention would not apply.

Your trial records do not discus the matter, they address earlier issues such as the '13/'14 IA that was expected to have an efficacy review but was nixed.

There is no proof of the futility theory, that is true. But we do have these facts:
. A still unexplained FDA Clinical Hold
. An IA gone MIA
. Trial running years past the primary and secondary endpoints
. Changing the trial SAP, including redefining the primary endpoint

That sounds a hell of a lot like something when wrong, not right.

Feel free to wait on "proof" one way or the other.