Tuesday, May 31, 2016 10:18:14 AM
If what you say is correct, even though NWBO left clues that manufacturing issues might likely be the reason for the temporary halt, then the next potential reason for the halt might be a rebalancing of mesenchymal subtype patients in the main arm due to pseudo progression and rapid progressor exclusion. Rebalancing would be for all subtypes if this is occurring and would be good science since a skewed patient population generally leads to skewed results. The company would need permission to have this done since the evidence tends to suggest that the 4 subgroups of GBM were not being individually accounted for in the original protocols.
Rapid enrollment can also be cause for a temporary screening halt. Regulators do not want skewed results caused by immature data so data is sometimes allowed to mature before screening for enrollment is allowed to continue. The rapid enrollment by the German hospitals may have caused this situation to occur.
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