ski, I understand what you are saying about unnecessary and overly burdensome regulations, and I agree only to an extent. I think what you’re suggesting is extreme, and potentially would lead to unsafe and ineffective treatments being approved. I believe the amount of information that is necessary to prove that a medication or treatment, (that sick people ingest, and has the potential to kill them) is safe and effective, and can be manufactured at high quality, should be quite rigorous. I for one, am grateful that I live in a country that has high standards and regulations that attempt to protect its consumers and citizens from harm due to corporate greed and malfeasance. I appreciate the cautious approach that the FDA has taken in recent years (after the affordable care act was passed) to cut through some of the unnecessary red tape, and speed the drug development and approval processes.
While I think the JAMA article provided clear evidence that the addition of DCVax to the standard of care, is safe, and did increase survival meaningfully, no I don’t think that alone provides enough information for regulators to approve DCVax. For one thing, the article did not include the manufacturing data and analysis which proves that DCVax can be manufactured to meet commercial specifications, (which could account up to half of the pages in the marketing application) and there’s a significant amount of evidence outside of the clinical trial, (confirming DCVax is safe and efficacious) which I think regulators should also consider.
