Mar. 12 at 11:37 AM
$CTXR Clip from the D Boral webinar yesterday, regarding Mino-Lok.
https://dl.sndup.net/yhchh/2026-03-11_ML_clip.mp3
“Somewhere in the next couple of months, I'm hoping that we'll get…a decision out of the Agency, whether it's that we can file or we may have to do a repeat something in this process. We don't know that yet, that's still under discussion.”
AFAIK, this might be the first time that Leonard acknowledged the possibility that they may have to run another trial for Mino-Lok. The analysts hypothesized if they had to run a 2nd study, it would potentially involve 150 patients, 18-24 months, and
$10M-
$12M. Leonard replied that he was "in the ballpark with that."
Now we have a better idea of what they ware waiting on. Confirmation from the FDA on whether they can file an NDA for Mino-Lok or if they have to do a 2nd study.