NorthWest Biotherapeutics Inc (NWBO)

[ou71764]

If there is an early halt, I think we'll trade at $50-$100 per share within 1-2 days. So I hope you're right, Flipper! We could know as early as next week. The original estimate was January 21 - February 4 for the recommendation from the DMC.

But an early halt at the first interim review is a long shot. I say that due to the math of enrollment and the statistical calculations, not my concern about efficacy.

The data from DCVax-L is probably very good to date, but I doubt the enrollment prior to September, 2012, was high enough to get us to statistical significance yet. That's the key date, assuming that the PFS average in the control group is 9, and someone on DCVax-L has to hit 15 months to be considered a success. Anyone enrolled after September, 2012, wouldn't have had time to reach 15 months of PFS as of December, 2013.

And the number of patients affects the statistical calculations. My guess is that the data as of December, 2013, probably does show that the vaccine has a PFS of 6 months more than the control group - and they still won't recommend an early halt because the statistical confidence won't be there yet.

It is encouraging that there have been other early halts recently. And this is a medical need that could sway the DMC's decision if they're on the fence. So, while logically I expect no news other than a "continue" from the DMC, occasionally I do allow myself to think about waking up to a PR about early approval. What a day that would be, for patients and investors alike!

But if we have to wait, we wait. If not the first interim review, the data could still justify an early halt at the 2nd one.