Tuesday, April 25, 2017 4:36:03 PM
iclight,
Primary endpoint always matters but in a terminal disease without much to show in the way of improvement from treatment for many years the OS end point trumps all with regard to any consideration for approval. The company and patients move giant steps forward with positive OS results. Any argument against this is useless because of the obvious need for something better and what regulators would face from patients and their advocates if not approved on OS and quality of life improvement. Of course you could always argue that regulators should just tell cancer patients to all go to India for DC treatment. Best wishes.
Primary endpoint always matters but in a terminal disease without much to show in the way of improvement from treatment for many years the OS end point trumps all with regard to any consideration for approval. The company and patients move giant steps forward with positive OS results. Any argument against this is useless because of the obvious need for something better and what regulators would face from patients and their advocates if not approved on OS and quality of life improvement. Of course you could always argue that regulators should just tell cancer patients to all go to India for DC treatment. Best wishes.
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