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Biotech Stock Mailbag: Northwest Bio, Amarin, Titan Pharma

The 119 "matched patients" were not enrolled in the DCVax studies. Northwest Bio doesn't tell us how they were chosen for this faux control group. What was the baseline health of these patients? We don't know. How was their GBM treated? We don't know. When were they treated? We don't know. Were other GBM patients excluded from inclusion in this faux control group? If so, why? We don't know.

Northwest Bio simply wants you to suspend critical thinking and believe the 20 handpicked GBM patients selected for treatment with DCVax by an investigator at a single hospital lived more than twice as long as 119 other hand-selected patients who weren't enrolled in the same study. On top of that, Northwest Bio has the chutzpah to claim the benefit conjured up in this ginned-up survival analysis is statistically significant.

Don't fall for the trick.

Northwest Bio has even shape-shifted the ongoing phase III study of DCVax in GBM patients to make it look more robust than reality. The study is designed to enroll 300 GBM patients who have already undergone surgery, radiation and Temodar therapy. They're then randomized to receive DCVax or a placebo, with progression-free survival as the primary endpoint.

What the company wishes investors would forget is that this DCVax GBM study began life as a smaller phase II study in 2006-2007, which was never conducted or completed. Instead, the study underwent numerous changes and was stopped and re-started. Last May, Northwest Bio decided to upgrade the study and call it a phase III clinical trial.

The company can call the study whatever it wants, but the fact remains the only prior data on DCVax in GBM comes from 20 patients, all enrolled at a single center. There is no survival benefit, no credible data to believe DCVax is having any benefit for patients. The last cancer-focused company to jump from a tiny phase I study right into a large phase III was Celsion (CLSN) and that didn't turn out well.

Wall Street largely shunned Celsion until the very end because no one believed its data, which sounds a lot like Northwest Bio.

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