I find this line total line of thinking or concern about future disclosure risk somewhat misses the point given very drug has side effects and it's just a matter of to what the extent. FDA wants the Rolls Royce version of a phase 3 trial so let's assume they are capable of analysing and deciding from the data whether the AE knock out PPS as a treatment for AO or if not what level of disclosure is required before it is approved for use.
Elmiron, page-24
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