>>"I think we are in a PH1/2 trial..."
Exactly right. If you recall about a year back, CTIX management talked about the choices regarding a Phase 1/2a trial verses a less costly Phase 1 trial that included Phase 2 as secondary outcomes. In choosing the latter, should efficacy be achieved in later cohorts, then it will allow skipping Phase 2 and going directly to a pivotal Phase 3 that would lead directly to NDA and approval for those cancers with statistically significant efficacy, which can be extension of life another 2 to 3 months for Stage 4 resistant cancers.
In the meantime, something else happened, Breakthrough Therapy came into being under FDA regulations. For every application of Kevetrin against specific cancers that show results aligning with pre-clinical data, and demonstrating high efficacy, it is more than just possible for approval for use against Stage 4 cancers without Phase 3 testing. Then for other cancers and for combination therapies, at least Phase 1a or 2a would be required prior to approval for those indications. Leukemia comes to mind as one of those indications as well as highly resistant renal cancers.
None of the above is totally out there pie in the sky projections, and all of the above can be in place within 12 to 18 months, easily. If in 12 months Kevetrin accomplishes all endpoints with high efficacy, what do you think will be the terms of a license? HEP C was worth $11 billion. What would a cure for Leukemia be worth (mice given human Leukemia were CURED.
![](/m/images/thumb-up.png)
![](/m/images/thumb-down.png)