NorthWest Biotherapeutics Inc (NWBO)

[Doktornolittle]

On a more positive note from me: If a consideration of some kind of approval has been part of the hold; consider all the regulatory statements that have been posted regarding competing therapies. They have to look at everything that is reviewable including competing therapies.

There is a lot going on in GBM. There was the Celldex Ph 3 that could have impacted any decision about DCVax-L and forced a look at subroup issues that had not been delineated by NWBO.

But Celldex is not the only one with GBM trials going on, and since the FDA supposedly looks at Ph2 data also for possible early approval, you have to consider the Ph 2 trials that were timed for data release at ASCO. I can think of at least 2 such trials. It is easy to imagine that once things got delayed for Celldex, and more data requested (for whatever reason) that put them close enough to ASCO to wait for those Ph 2 trials to report. If so, they could be looking at that data now as a final consideration.

Maybe the mfg patent issue was also in there as a chunk of the delay, but these competing trials and ASCO may have added to the mix. How long to review that data? I don't know. Certainly easier a ph 2 than a ph 3, but not sure. At least it should already have been compiled by ASCO.

So, plenty of possible good scenarios where transient SP is a small consideration.