Thursday, October 16, 2014 3:11:33 PM
1. The positive Brilacidin P2a efficacy and safety results from prior clinical trials. We already know Brilacidin works and is safe, we're just determining how well, and whether it can gain an edge over Daptomycin. This P2b is closer to a dose optimization trial as KarinCA has pointed out.
2. The improved safety result appears already known, from the overall that's been reported for the P2b trial. Looks better than the P2a.
3. The CEO's positive comments on the overall trial efficacy. It seems reasonable to assume at least one Brilacidin arm will form the basis for a Phase 3 pivotal clinical trial. But of course the data will be the real result.
4. Considering that this is a P2b with efficacy and safety already demonstrated in prior trials, and that there is another P2 for another indication set to begin, Brilacidin-OM; my view is this is not a pass or fail trial for Brilacidin, meaning not a pivotal trial. That is, even on not great results, it is not the end of clinical trials for Brilacidin.
5. The Kevetrin trial is going swimmingly, it has essentially already met primary endpoints of safety at a dose in the range believed therapeutic. At least one additional Kevetrin combination trial is already set to begin. CTIX already hit $2.47 on just Kevetrin at an early stage of the current trial.
6. The Prurisol trial looks like a go.
7. CTIX has enough financing in place to continue with these other clinical trials regardless of the results of this one.
8. The confidence of other knowledgeable posters on our board whom I respect.
So my opinion is this trial is set to either give us an early win, with a strong chance at a partnership or buyout of Brilacidin, or it is a speed bump for a company I was already willing to hold shares in at a variable range. Obviously I prefer the win now, and feel good about the odds.
I caution that I've clearly drunk the kool-aid here, and I welcome opposing opinions. There is always risk, and the risk is real. But I like the chances of a good Top-Line result for this Brilacidin P2b clinical trial. I feel added confidence from all the other trials that are independent of this result. These other trials form a good safety net IMO.
If this was a Pivotal Phase III trial, with a sharp CTIX share price rally having already occurred, I'd consider taking basis or partial profits prior to results. I hope for the opportunity to consider this in the future at a significantly higher share price.
"Games are won by players who focus on the playing field -- not by those whose eyes are glued to the scoreboard." - Warren Buffett
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