Replies to post #677842 on NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

I'm certainly no expert, but I believe that if a patient's tumor is large enough they can get sufficient lysate to make two separate batches, and leukapheresis to do the same. One batch can be made manually the other in the EDEN and comparisons can be done with the use of tiny amounts of the vaccine from each batch. This would probably be done with patients in the compassionate use program with some advantage to the patient for doing it.

If others care to suggest a better way of doing it, feel free to chime in. To me, the advantage to the patient is having far more vaccine as long as comparisons prove to be positive. As long as sufficient vaccine for normal treatment is achieved from the manually produced effort the patient shouldn't be harmed in any way.

Gary

[FeMike]

Please explain how one can do a manufacturing comparability study w/o humans undergoing leukophreisa?

The same way they have been running the studies on the Flaskworks devices.

Comparability studies do not, however, require the vaccine to be administered to patients in a trial setting or otherwise. The comparability is determined by a suite of lab analyses.