NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

exwannabe,

Very carefully crafted avoidance of “exceptions to adequate and well controlled trials” guidance will not achieve any hoped for point to be made. When the measures a trial begins with are the best available at the time but inadequate to properly quantify treatment effect, the exceptions rule can be utilized to demonstrate the issue and provide a potentially acceptable solution which can only be fully validated by actual approval based on it’s use. What this trial will demonstrate is that FDA and at least one other regulator interfered with trial powering based on a look at data by regulators that pointed to statistically relevant data that led regulators to the screening hold and non enrollment of the final 17 SOC/placebo patients. You argued that regulators were involved in order for this to happen at that time and I have not forgotten that, in fact I agreed with that. Good news turned into bad then, now back to good news with greater understanding presently of what was in play then ; ). Best wishes.