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Re: Doktornolittle post# 3039

Friday, 12/27/2013 12:49:13 PM

Friday, December 27, 2013 12:49:13 PM

Post# of 700564
Doktornolittle,

From 2000 to 2005, consider that, even after initial s.o.c. chemo and radiation therapy, Dr. Liau's trials (and many other dendritic trials under the same time frame) included a significant population of patients with verifiable tumor progression present at the time they started DCVAX therapy.

Now, in the phase 3 trial, those with tumor progression (or even pseudo-progression) present after chemo and radiation, but before DCVAX therapy is initiated, are not included in the primary study.

There is considerable consternation by certain authors, analysts, posters and others who state that NWBO "cherry picked" in their first 3 phase 1 trials.

Quite the opposite.

In fact, it was not until phase three that NWBO was able to exclude patients exhibiting progressive disease after s.o.c. but before DCVAX therapy was initiated. (those patients with concurrent progression were either moved to compassionate care or a separate study).

So, unlike most trials, NWBO was able to ethically and appropriately 'cherry pick' their patients for the phase 3, 312 patient study.

DCVAX-L works significantly better on patients with stable disease at the time therapy is initiated. This includes Response Rate, OS and PFS v. s.o.c..

While I could address most if not all of your other concerns, I just gave you a golden ticket.
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