When I entered in 2016, we were just waiting for the DCVax-L Phase III Interim Analysis. It took nearly two years before the journal was finally published. Then it took another two years to lock the data, and another two years just to read it — which eventually appeared in the JAMA Oncology publication in May 2022, finally presenting the long-awaited trial results. Later that year, Northwest Bio released the topline data in November 2022, confirming the survival benefit of DCVax-L.
Since then, it’s been another waiting game — this time for the Marketing Authorization Application (MAA) submission. The company reported progress toward completing the MAA throughout 2023, and in December 2023, they finally submitted it. Yet here we are, still waiting for the regulatory decision.
Nine freaking years and still counting — from the Phase III interim publication to the pending MAA outcome.
People kept saying we were at the end of the tunnel, but somehow that tunnel just keeps stretching farther and farther.
Will there ever be a milestone that doesn’t take two years to reach? Labeling alone typically takes two months. But with NWBO, of course, it’s a minimum of six months to a year — because it’s “complex,” blah blah blah. Is it really that complex, or is management just incapable of handling tasks in a timely manner?
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