Northwest Bio CEO Discloses More Problems With DC-Vax Brain Cancer Study
Powers' best whopper this afternoon was her claim that the DC-Vax phase III brain cancer study was robustly powered so that the primary endpoint of progression-free survival could reach statistical significance with a p value of 0.02. Most phase III trials only hit statistical significance with a p value of 0.05, which just shows you how awesome the DC-Vax study really is, Powers explained.
Um... a clinical trial requiring a p value of 0.02 for statistical significance means the success threshold is HIGHER and more difficult to achieve! Yet Powers spins the bad news in the opposite direction.
And why would the DC-Vax study require a p value of 0.02 for statistical significance? Powers didn't say but here's a good guess: The study has been so poorly run and the data have been looked at some many times already that the "alpha spend" has been gobbled up. What was once a study which could have achieved a statistically significant result with a p value of 0.05 now can only win with a more difficult p value of 0.02.
Good luck with that, Northwest Bio.
Powers' whopper number two: The company has the "luxury" of adding more patients to the phase III study in order to further derisk it. Again, only in the "black is white, white is black" mind of a stock-touting biotech CEO is adding more patients to a study a positive. The truth is quite the opposite: If Northwest Bio chooses to increase enrollment in the phase III study, it will do so out of concern that the original enrollment figure (312 patients) is too small to produce a positive result.
Speaking of patient enrollment in the phase III study, how's it going?
"Just fine," said Powers.
Can you define, "Just fine," please?
"On track and according to plan," said Powers.
But Last March, Northwest Bio told investors the phase III study would complete enrollment in the current quarter or early in the second quarter. The company backtracked in September, guiding towards the completion of patient enrollment in "late summer" of this year, assisted by all the promised German and UK hospitals.
How many patients, exactly, are enrolled in the study to date?
And what about the interim efficacy analysis of the DC-Vax phase III study which Northwest Bio claimed was being conducted last December. The end of March is upon us, so where is it?
Cue the smoke machine, it's time for Powers to work her magic on reality.