I understand your opinion, but I do not agree with your opinion. I believe that the FDA will quickly review and approve DCVax-L, once the BLA package is submitted, accepted and reviewed.
I take Dr. Pazdur at his word, when he said that the FDA wants to be the world leader in approving new safe and effective oncology treatments, especially those treatments that will become a new break-through treatment to meet an unmet need.
The FDA will have to approve DCVax-L for it to become a foundational part of the new standard of care (SOC) to treat ndGBM and rGBM patients worldwide.While a DCVax-L approval in the UK will be a very positive milestone, that country is too small on its own to justify making DCVax-L a part of the SOC to treat all GBM patients. The US / FDA will have to help make this happen.
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