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03/30/16 5:26 PM

#57936 RE: Ready4bluesky #57933

Ready... first, the hold was initiated prior to the investigation being called for by NW.

Besides, the trial would never be effected by whether Linda is paying Cognate too much or too little to make the vaccines, build up the infrastructure to actually manufacture the vaccine in the event of approval, determine whether Navid Malik was paid money in 2012 to write a report, and whether the patents were still owned by NWBO.

Right in front of us is the fact that there is screening pipeline that lasts 3 months. Pretty sure that trial is almost full. Hence, the screening halt may never lift. Dang.

safin

03/30/16 5:41 PM

#57938 RE: Ready4bluesky #57933

That's preposterous.

Stillwell888

03/30/16 5:41 PM

#57939 RE: Ready4bluesky #57933

Not sure about the investigation but maybe you're right and screening halt effecting both L and Direct. As cell necrosis happens the cells and mitochondria swell before bursting which releases chemicals that are inflammatory. We were told about the direct patient who had a sarcoma which they thought had progressed but in actually was just a massive build-up of dead cells. This is probably happening within the skull too for L patients. If so then the problems I see are how do you tell if it progression or not (much easier outside the skull) and is the cell death happening so fast that the body can't deal with it. Hence the need to measure TIL and look at TCR sequencing to see if the vaccines are working? So until they sort this out maybe the FDA will not green light the Direct Phase II or continued screening of L patients. Then again this is mere conjecture a I could be totally wrong but this or something similar would explain a lot.