That's the 2nd time TST has used "actionable" in PR re FDAActionable: first meaning: giving sufficient reason to take legal action. So I'd love to see a class action suit filed by NMIBC patients vs. FDA for withholding access to MCNA (better efficacy than current 2nd-line therapy and fewer side-effects) during an ongoing global BCG shortage. I'd like to see how the FDA would explain that no, we can't allow you to have MCNA although a P3 study that we designed and approved might give 25% of you extended remission (ie >2 years) or prolong the time you can delay having cystectomy because of politics, or red tape, or national pride. Yep: that would be hard to defend.