Replies to post #41905 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Trying to determine how VS-6063 received permission for a large phase II blinded study without more early pfs data. They kept showing slides of 12 day tumor shrinkage in phase I study, but nothing additional regarding pfs except they would bring up a Japanese patient that was doing well. Maybe because mesothelioma is such a man made disease, it went to trial faster....dunno. DCVax-L's trial started after multiple phase I/II studies, compassionate use experience, prior tripling of pfs, etc.

The other take away/difference is that DCVax-L suspended enrollment screening temporarily, and at the same time appears to be expanding its Memphis facility into next year, Woodford continued to invest in August, it appears enrollment continued even after new screenings were suspended, and the company made certain nobody confused suspension with trial halt. (Shorts trying to turn "good news into bad news.") Moreover, there is the work of RRR and Senti which seems to indicate clinics thought the new temporary screening/recruitment suspension were for positive reasons. Multiple German clinics pursuing reimbursement for HE. Continued treatment of patients in the trial. NWBO filing documents with regulators and two way communication. This does not at all look like VS-6063.

[Stillwell888]

Interesting how Verastem announces suspension and stop for futility on the same day. It has now been about 6 weeks from announcement of enrollment suspension by NWBO yet the trial continues so this makes me believe that futility is not the cause of the stoppage. In addition this is a Phase III (not that this means that DCVax-L will have a positive result) not a Phase II so the treatment is much further along in the trial. Also, the information arm of 51 patients has had very good results so this is more evidence that it works.

[f3tt3f]

However, in the case of NWBO, enrollment hasn't stopped. Just the screening aspect.
Which is unusual.