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Thursday, April 02, 2015 8:01:07 AM
Here's why:
Let's say median survival for these sick patients is just the median one expects to see for rapid progressors with standard of care.
Standard of care involves a grueling regimen of chemotherapy and radiation, which are (and correct me if I am wrong) continued until they stop working and the patient dies. Treatment is often discontinued because the patient cannot endure the debilitating side effects, especially from the chemo. How that proceeds would vary from patient to patient, in part based upon how much the patient can endure.
Under SOC those last months are generally awful with very poor quality of life because the side effects of treatment are so bad.
By contrast DCVax L gives patients the same final months with virtually no side effects.
Which treatment would you want, if you cared about your last months being good ones?
Don't forget Damaged Immune Systems:
Unwittingly Feuerstein made a point for NWBO when he made hay about the fact that the Information Arm is outside the main Phase III trial.
Remember that many of these patients have damaged immune systems too, immune systems that were damaged because they got SOC up until trial enrollment.
DCVax uses the immune system, so no immune system = big problem.
The Information Arm was not updated to account for this. It has not received additional patients and is not being analyzed with this problem in mind.
This is no small issue.
This was the reason NWBO had to enroll extra patients and thusdelay the end of the Phase III trial by a whole year.
This was no small decision beccause doing that will result in the deaths of an untold number of patients who won't be around for approval, but would have been if the trial was completed on time.
From a business standpoint you have the opportunity cost of an entire year of lost revenue.
Still this article by Feuerstein shows why that decision was taken by NWBO, however hard it must have been from a humanitarian and financial standpoint.
NWBO did not want to roll the dice and stay on schedule in part because people like Feuerstein at the FDA could make this very kind of argument and prevent approval from taking place at all.
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