Agree Ces…..to read details of ‘despite the demonstrated success from an EAP’
the company was issued a CLR……..it is a reality check on exactly what we are dealing with. Our BLA journey has been complex & expensive…..laced with ‘good cop bad cop appraisals & regulatory red tape. We are not ‘over the line’ with this despite all of the encouraging data and successful patient outcomes. We should be……but………
Entering the PAZ - give us your predictions!, page-182
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