AWESOME! This looks like it is going to be a fast
Post# of 72446
Posted On: 06/15/2016 12:08:08 PM
AWESOME! This looks like it is going to be a fast turnaround trial. 6 weeks of treatment, up to 3 days of endoscopic screening, and then a gastroenterologist is reviewing the photos and videos. Given that only 18 sets of screenings need to be reviewed, and that is is all visual evaluation (no lab tests or other slower things) I'd be willing to bet that the reviews are complete in 18 working days or less. Then CTIX compiles the top line data for a few weeks and BAM it's done.
That math says B-UP results are complete as early as the beginning of September, so to be cautious we could get full trial results in the beginning of October. That's 4 to 4 1/2 months, start to finish. Super fast!
That math says B-UP results are complete as early as the beginning of September, so to be cautious we could get full trial results in the beginning of October. That's 4 to 4 1/2 months, start to finish. Super fast!
Quote:
The ulcerative proctitis trial is planned to enroll 18 adult patients with Brilacidin administration through retention enema at three different concentrations once daily at bedtime for a 6-week (42-day) period. Endoscopic evaluation of the rectum and mucosa, up to 40 cm from the anal verge, will be performed at screening and at the end of treatment/Day 42 (± 3 days). All endoscopic evaluations (screening and Day 42) will be photographed and videotaped for eventual adjudication by an independent observer (a gastroenterologist) who is blinded to the day of on-treatment endoscopy and the dosage of Brilacidin used. This process of blinded adjudication (assessing overall results) will be performed after the study's completion and will not delay patient enrollment.
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