My quick take on chances of p3 success
In general the chances of any p3 passing are 2 in 3 across bio. So that's the base case and could be higher or lower depending on specifics. To come up with an okay guess for Mino-lok passing p3, one would have to look at the p2 trial and what happened, and just as importantly, determine what an acceptable p3 would look like, and then factor the difference that bridges the two.
The p2 was 49 out of 50 or a 98% success rate. This is way above the threshold for success which is now 65%. Note that it was changed from 75% to 65% by the fda which is fantastic imo.
Overly bullish article perhaps but decent dd here, https://seekingalpha.com/instablog/50299941-north-shore-research/5557969-ctxr-blockbuster-pharma-still-under-radar
I'm not going to do the statistical math but meeting above 65% on a larger sample size when the smaller sample size was near perfect seems extremely doable. I have to say though - things happen in this industry, random chance unforseeen situations - nothing is guaranteed in bio. High risk high reward.
IMHO, not a doctor, not a wall street guy, I think the chances for success are around 4 in 5 that it is eventually approved with a few fda caveats and 3 in 5 that it gets quick fda approval with no issues at all. 1 in 5 that it just straight up doesn't meet the end point or that it barely meets the end point and still tanks because it's just not as exciting of a drug and the p2 was a fluke.
It's also worth noting the chance of eventual FDA approval after a successful p3 is 90%, so a solid p3 well above the threshold is looking great for making its way to the market.
To take the counter position and be the devil's advocate (which I always recommend when accessing a stock), my bear stance is, why is no one talking about this stock? Why is it so under recognized even this close to p3? Are we really this deep under the radar? It's not that typical of this stage in the pipeline. Also CRMD, cor medix, is competition, with their product, DefenCath, and their success or failure is an additional variable in play. They are stalled in the fda process but if they can navigate this situation quickly and beat ctxr to approval it will affect just how much ctxr pops, given success. Granted, they have different solutions entirely but it's still in the same unmet medical need category of cathetor sanitization. These stocks often trade opposite to each other so there is definitely an element of competition. To my knowledge the main difference is DefenCath is preventative and Mino-lok is a mitigative treatment so there is likely room for both.
https://www.cormedix.com/defencath/
With that said, this isn't my first rodeo. I rode AUPH all the way from $2 to $20 from their p2 to fda approval. I trade in bro all the time. I've been loosely following CTXR for 3ish years and it just looks like low hanging fruit. It's under recognized, I think, because it's not sexy like stem cell research or cancer cures. It's practical and perfectly within our technological means. I also am impressed by the two co founders and the way they have managed the stock. That's why I think it will succeed.