False, Medical Device approval requirements are just as rigorous as a drug approval. Think about heart values, or stents, etc. that are essential for patients to survive.
Perhaps actually reading the NWBO trial inclusion criteria would be worthwhile:
"Primary therapy must consist of surgical resection with the intent for a gross or near total resection of the contrast-enhancing tumor mass,"
Biopsy only would not be acceptable. Nowhere in the ECA criteria is a requirement for "gross or near total resection." They also didn't have any criteria for multiple treatment exposures.
It is a mountain, when a trial is so biased that no valid conclusions can be made from it. The other issue is the External Comparator protocol was NOT established BEFORE the trial, That is a requirement of the FDA New ECA Guidance. All this is obvious to regulators and is likely to lead to rejection. That is a MOUNTAIN.
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