Wednesday, February 24, 2021 7:35:59 PM
Personally I believe if it were zero improvement in life span, but better quality of life, it should result in approvals. What's rarely tested is, can life be extended substantially by alternating use prior to patients becoming refractory to SOC treatment. Decades ago IMGN had Oncolysin's in trial that patients rapidly became refractory to, but after just weeks of treatment with those drugs, the patients were no longer refractory to SOC treatment which they became refractory to. Nothing ever happened from that finding, I doubt if it could have been a profitable treatment for the company, but no telling how many times such cycles could be done. The SOC treatment often worked for years, if a drug can essentially reset the treatment, such cycled treatment might permit people to live for decades. We'll never know because the regulators are always looking for drugs that work better than what exists rather than drugs which may make existing drugs work better.
I'm a believer that if something is proven safe, and especially if it improves quality of life, approval should be based more frequently on that, not purely beating other products on length of life. I believe that in some cases, the drug not known for duration will be just what may cure a small percentage of the people. Trials are simply not experimental enough to find the subsets that get exceptional benefits from the drug.
By themselves I don't believe that the DCVax's extend survival if patients are removed from other treatments, but when they supplement other treatment they may actually lead to a cure.
Gary
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