Saturday, February 17, 2024 8:26:16 PM
Some of our bashers would have us believing the BLA is DOA because changes were made during the trial. It doesn't matter to them that the regulators were involved in the changes, it's why they say it's a failure. We know better, but while it may not have been discussed for months or years, they make a statement and restart the debate.
No trial is an absolute certainty, but to me it would be a crime if any of the regulators substantially delay it's approval. We all know that DCVax-L will do much better when combined with other therapeutics, but that's no reason not to approve a product that more than doubled life expectancy at 5 years. Most cancer products can be approved if a 10% survival improvement is proven, we did roughly 160%.
Gary
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