"You wanna pretend Leo did not bury the B UC delayed release problem? Of course he did. There has been ZERO discussion of the issue here till KMBJN caught it on this 10K."
I'm not so sure that it was a complete burial.....if so, it was in a shallow grave.
This is from the 10-Q issued in May, PRIOR TO the 10-K filed in September (highlights other than the section title are mine, obviously):
IBD, Ulcerative Colitis (UC) — Brilacidin is also being developed as a treatment in more extensive forms of IBD. Development of an optimized oral formulation is in progress including dosing forms first aimed for the treatment of ulcerative colitis and then Crohn’s disease.
Initial clinical testing, in a Phase 1 single-dose escalation trial, tested a Brilacidin oral formulation prototype in healthy volunteers to assess targeting colon delivery, dispersion, safety, toleration, and systemic exposure/ pharmacokinetics. Data from the Phase 1 trial (NCT03234465) studying the use of delayed-release tablets of Brilacidin showed the trial met its primary endpoints. In the study, the timed-release formulation of Brilacidin was radiolabeled (with complexed technetium-99m) and evaluated for safety and colonic delivery in 9 healthy volunteers (6 with Brilacidin and 3 placebo). Gamma scintigraphic imaging was used to visualize in vivo performance of the enteric coated delayed release tablets designed to target delivery of Brilacidin (50mg, 100mg, and 200mg) to the colon. For Brilacidin treatments, radiolabel release was observed in the ascending colon for four out of the six subjects and in the terminal ileum for the remaining two. Following release, dispersion of the radiolabel was then observed throughout the colon. Serial blood samples were collected through 24 hours post-dose to assess absorption of oral Brilacidin from the colon. Blood level analysis, using a sensitive limit of quantitation in plasma of 1 ng/mL, demonstrated no quantifiable drug concentrations at any timepoint across treatment cohorts, and appears to show containment of Brilacidin within the target location of the colon when delivered by delayed release tablets. Safety outcomes showed that Brilacidin delayed-release tablets were well tolerated by healthy volunteers across all treatment cohorts with no serious adverse events reported. Of the 9 subjects treated, 2 subjects on Brilacidin and 2 subjects on placebo experienced at least one adverse event. The adverse events were of mild intensity and none were deemed to be related to study treatment.
Our oral program development will be supported by a modified release oral capsule formulation now in development. Regulatory approval will be sought to initiate a planned double blinded placebo-controlled Phase 2 clinical trial in UC patients and is anticipated to begin in 2021, pending completion of drug formulation work and securing sufficient drug supply and working capital. Clinical study protocol details have been outlined and sent to vendors pursuant to an RFP (Request for Proposal)."
The fact that "There has been ZERO discussion of the issue here till KMBJN caught it on this 10K" may be a failure of "here" to read the filings a bit more carefully. As you can see it was pretty plain back in May that the Company was moving on from the delayed release design to a "modified release oral capsule formulation" and then into "immediate release formulations due to unexpected findings encountered" as described in September's 10-K.
So the transition was announced, if ignored, in broad daylight. It's the "unexpected findings encountered" stuff that we should have heard more about and probably never will.
As my dear old grandfather Litvak said (just before they swung the trap), he said "You can't cheat an honest man. Never give a sucker an even break or smarten up a chump."
