Replies to post #16792 on NorthWest Biotherapeutics Inc (NWBO)

[inveterate]

This would be a substantial change - not only in the timeline but in the cost as well. Wouldn't management have been required to report this change?

[longusa]

Thanks Eval - not enough coffee when I posted!

[ou71764]

I am disappointed in the expansion of the size of the DCVax-L trial. I hope LP comes forward and discusses it candidly.

The rule of thumb I use for companies with no revenue is that a dilution takes place when there's 6 months of cash left.

I am guessing LP will have some good news in her presentation. How good, I don't know. But at the very least I am expecting a mini run-up in the stock price. Then sometime in the very near future a secondary.

[Pyrrhonian]

60% of the initially planned 110 events were hit on Dec 10, 2013. At that time data was unlocked and delivered to the DMC for both safety and efficacy analysis, which they performed. The timing at which the second interim would trigger is now far off, however. Unless there was some miscommunication of the updated event data. At any rate, the two (interim look for sample size recalc by an independent statistician, triggered at 80% enrollment, and first interim analysis by DMC triggered at 66 events) are quite separate things; the sample size recalculation was done by an independent statistician who viewed event data with treatment assignments blinded who then told NW by how much to increase the sample size and total events. He did this after computing the variance between what he saw and the trial designers' initial assumption of TOTAL GROUP event rates. Being lower than anticipated, and not knowing if that means placebo group or tx group is living longer than initially assumed in the trial design, the way to even out this increase in variance is to enlarge the trial, and by an amount relative to the higher variance.

That being said, there's no reason to no longer think a BLA is currently being assembled and possibly submitted (rolling review) for Accelerated Approval based on that first interim's data. However, when the trial may officially conclude (if not at the point at which Accelerated Approval is granted) is now anybody's guess. If AA is not granted at some point (anywhere from this fall to next spring, possibly summer if there is some drag or further requests for additional data by FDA/EMA) and the trial is continued to its primary endpoint's new conclusion of 248 events (assuming that is correct info--it may not be), that would put the primary completion date out somewhere around late summer 2016. Second interim of 199 events may be around winter 2015.

The two big clues imo are the interim efficacy data recommendation not being delivered to the Sponsor and the sample size increase, indicative of lower event rates. To me that spells a BLA is currently being filed for AA. And so this increase of events required to conclude the trial may not matter, as the trial concludes once AA is granted.