Sunday, December 30, 2018 12:50:00 PM
And yet here we are holding the asset. Whether he outfoxed BP will be dictated by the terms of whatever deal we make on it. My bet is he will end up looking like a genius.
CTIX ran the phase 2B for ABSSSI. There was no alleged about it. B-ABSSSI roughly matched 7 day dosage of Dapto (Cubicin - $1B/year in sales) with a single dose of Brilacidin:
B 0.6mg/kg x 1 day = 47/51 (92.2%)
B 0.8mg/kg x 1 day = 46/48 (95.8%)
B ?? x 3 day = 51/552 (98.1%)
Daptomycin (Cubicin) x 7 day = 48/50 (93.8%)
These results are rock solid. A single dose, with a different MOA and different resistance, matched a 7-day heavy-hitter ABSSSI drug. This has value and it is considerably more than $20 million. The company won't be going sub-penny sitting on this.
You are taking liberties with a lack of information. Can you elaborate on these "serious concerns in the SPA appication" expressed by the FDA with documentation? If not, please don't state your own suspicions as fact. All we know is that the cost of running the trial ourselves would have been too expensive at the current time.
Final sub-group analysis containing the most compelling data was performed earlier this year. Deals take time and IPIX likely wanted to find out whether BTD would be granted along with the details of the EOP2 meeting before entertaining final negotiations. Now that all trials have ended, and no more clinical trial progress can continue without a deal, I expect serious deal-making is underway.
We are obviously lacking information on this. The results were extremely impressive though. There really isn't room for claims of statistical anomalies or cherry-picking with the data we saw. The response rates were indisputable. Unless you're willing to entertain the possibility of outright fraud in the B-UP trial, it is hard to dismiss the stellar results. If you are willing to entertain this possibility then the company is not for you. I don't always agree with management but I do trust them.
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