Friday, August 26, 2022 2:24:26 PM
HyGro, what you call a failure I believe the company, the regulators, the clinicians, etc. would consider to be a tremendous learning opportunity. They learned that patients who's cancers appeared to be progressing weren't progressing at all, they were swelling in size, but the tumors were dying. Perhaps a trial could be designed where the goal was the determination that pseudoprogression occurred, that could end the trial far more quickly, rather than waiting for overall survival data. That however wasn't the trial design and in reality there is no telling how many other trials failed because of progression that was actually pseudoprogression, but they failed to determine that was the case.
The truth is, PFS has not proven to be that valid an end point even though regulators have accepted it as a way to greatly shorten trials. Approved drugs have been shown not to actually improve overall survival in spite of excellent results based on PFS. To my knowledge the regulators haven't pulled these drugs, they've allowed Doctors and patients to choose which drugs to use, but had the trials been run to OS, if they were approved it wouldn't be based on OS, but there are other reasons for approving drugs, especially if the treatment provides a better quality of life.
I believe that many of the products being developed today do offer better quality of life and that should be a consideration. I don't believe that having cancer will ever be considered pleasurable, but many patients today live more normal lives than those treated with the same cancers years ago, even if they aren't living longer. DCVax-L is a treatment that has virtually no serious side effects, in that way it's about as perfect as a product can be for treating solid cancers and it could become a big reason it becomes a product that's choosen to treat many solid cancers once it's available.
Gary
The truth is, PFS has not proven to be that valid an end point even though regulators have accepted it as a way to greatly shorten trials. Approved drugs have been shown not to actually improve overall survival in spite of excellent results based on PFS. To my knowledge the regulators haven't pulled these drugs, they've allowed Doctors and patients to choose which drugs to use, but had the trials been run to OS, if they were approved it wouldn't be based on OS, but there are other reasons for approving drugs, especially if the treatment provides a better quality of life.
I believe that many of the products being developed today do offer better quality of life and that should be a consideration. I don't believe that having cancer will ever be considered pleasurable, but many patients today live more normal lives than those treated with the same cancers years ago, even if they aren't living longer. DCVax-L is a treatment that has virtually no serious side effects, in that way it's about as perfect as a product can be for treating solid cancers and it could become a big reason it becomes a product that's choosen to treat many solid cancers once it's available.
Gary
Recent NWBO News
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