TELESTA THERAPEUTICS INC T.TST

RE:Sounds like the FDA has already made their decision imho

[Biofinder]

(and from page 45 of the FDA's AdCom briefing document)

10.4 Subpopulation of CIS-containing disease

As discussed in Section 7.4, MCNA treatment was associated with a 27% CR at 6 months with an mDOR of 15.1 months, comparable to that reported for valrubicin, the only FDA-approved treatment for subjects with CIS disease refractory to BCG therapy. Although not pre-specified in the trial design, such an observation might provide evidence of effectiveness for MCNA. Since active CIS disease does not usually regress on its own, complete response in this setting would reflect a treatment effect from MCNA. In addition, some CRs lasted more than two years, suggesting that these subjects might have benefited by not having cystectomy with its attendant morbidity. However, it is not clear whether some of these subjects were truly refractory to BCG and whether their disease might have responded to further BCG therapy if it had been given. 

(due your own due diligence, GL)