Sunday, November 20, 2022 4:31:35 PM
I think we’ll see a push to commercialization in the UK very soon.
The use of external controls will remain controversial right up to any regulatory approval and this won’t come just from some investors/pundits/bears but also from some in the medical community.
The doctors that I spoke to who participated in the trial are universally and strongly behind the therapy. But I’ve spoken to others, not involved in the therapy, and was surprised to hear they were generally supportive. Safety + unmet need is a strong motivator.
The real transformative opportunity for DCVax is when used in combination. But those trials never get done if DCVax doesn’t get approved. A 2nd Ph3? Similar problem.
The NovaCure device has role, but it would be a mistake to bring further DCVax development (combos/other cancer types) to a halt because NovaCure serves a certain subset of patients.
Any regulatory decision brings a certain set of consequences. Approval seems like the better choice if the objective is to serve the interests of cancer patients.
The use of external controls will remain controversial right up to any regulatory approval and this won’t come just from some investors/pundits/bears but also from some in the medical community.
The doctors that I spoke to who participated in the trial are universally and strongly behind the therapy. But I’ve spoken to others, not involved in the therapy, and was surprised to hear they were generally supportive. Safety + unmet need is a strong motivator.
The real transformative opportunity for DCVax is when used in combination. But those trials never get done if DCVax doesn’t get approved. A 2nd Ph3? Similar problem.
The NovaCure device has role, but it would be a mistake to bring further DCVax development (combos/other cancer types) to a halt because NovaCure serves a certain subset of patients.
Any regulatory decision brings a certain set of consequences. Approval seems like the better choice if the objective is to serve the interests of cancer patients.
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