Trial data is not "great: when it comes from biased trial design . Cherry-picking the trial participants alone biases the outcome. Then double the dosing regimen in the treatment arm also increases the bias. If you wanted pump results, NWBO sure did it.
Then redoing the protocol post hoc, which they had to do to be able to add a recurrent OS arm. (no placebo arm left). FDA Guidance for using ECA requires the ECA design and selection be completed BEFORE the trial begins.
Sorry, not a scenario that is going to play well with FDA. No oncology treatment makes any significant revenue without U.S. approval and marketing.
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