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Re: duderaja post# 49146

Wednesday, 12/30/2015 4:55:13 PM

Wednesday, December 30, 2015 4:55:13 PM

Post# of 744486
What flipper said made sense to me. Where they left of with the Direct trial was that they were able to predict the outcome fairly well for a given patient based on those markers.

So, are those markers under their control, or are they just a reflection of the patient's immune system health? In the next phase for Direct they will be trying to tweak the process to more repeatedly get the marker mix that they saw as successfull. Maybe they already know from tweaking in Phase 1 what worked in that regard, and what didn't work. If not, there will be more tweaking in phase 2. But they will see the results quickly, in terms of those markers. No gauruntee that accomplishing the successfull marker proportions from phase 1 will result in greater efficacy in phase 2, due to a question about cause and effect... but extremely likely that if they can tweak the process to get the marker balance they want then they will improve efficacy.

Once they have accomplished that they can start arms along those lines... and only then, likely, start adding a touch of blockade inhibitor, which is a tad dangerous, but may prove well worth the added risk, particularly when it might be needed in such low doses once they have the cytokine response they are looking for. That will be done in different trial arms from the optimized straight Direct arms.

Does that sound right Flipper?
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