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Re: md1225 post# 95996

Monday, 01/16/2017 9:34:18 PM

Monday, January 16, 2017 9:34:18 PM

Post# of 696922
Md, I would guess part of the reason dcvax would be used as a control is because it gets the t-cells to the area before pdl1 inhibitor is administered. You already have a group of patients which have received dcvax-l which may have evented or had a small response so you already have the data collected as to how that has worked (control). Previous patients whom didn't respond to treatment may be able to roll right over since the cells are already present and the vaccine has already been produced for those patients. Just keep using those patients, this keeps cost down and those patients have already been compared to todays standard of care so they are already for the next step. This would also keep trial costs down also. Then add the inhibitor to the mix and they will be able to see how taking the breaks off works with t-cells already there. As many Drs. have said you can have all the pdl1 inhibitor to the tumor but without the t-cells you don't have anything to actually pull a big enough response to fight. If it plays out this way this will be a very inexpensive trial for nwbo to run as much of the costs have already been done in the previous trial. The speed at which this phase II would take will be very fast also. Then if the safety profile is good and with the Cures Act and Moon Shot activated things could move very fast. Of course phase II trials are run slightly different in what they are trying to achieve but I assume it may go something like that.
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