Agree that Brilacidin is now the leading drug in terms of clinical development. Don't forget about the QIDP designation. The five-year extension of market exclusivity is very significant, although we might not see the benefits until Phase 3 is up and running.
When I first invested in CTIX, I knew it's going to be a decade long investment. This year will be year #4. These minor delays don't affect me at all. If an investor does not share the long-term vision of the CEO, then he/she should not be in the stock long-term.
Now, 4 months after that meeting, we've had no progress on that [Brilacidin] front.
We must not lose sight of the difference between "had no progress" and receiving news of progress. In 4 months I'm certain that CTIX has made plenty of progress in advancing toward the next phase clinical trial. Unreported progress would include:
Fully understanding based on additional data, including that requested by the FDA.
Delivery of that requested additional data to the FDA.
Draft(s) for protocol(s) based on FDA comments to date. CTIX does know what the FDA has in mind and will without question include several possible trial designs. The QIDP has several possible pathways any/all of which Brilacidin might qualify.
Application of latest data to the other Brilacidin trials: diabetic foot, OM.
Changes to the already approved protocol for OM based on the most recent data. Keep in mind, the OM protocol was drafted before the bottom line data for Phase 2b (which included more safety) and the additional PK/PD was available.