Some thoughts on the news1) PBI 4050 for anti fibrotic activity. Launching Phase 1 MAD.
Question is why? And why now? They have abundant data on hand from multiple previous (Phase 1 & 2) trials establishing SAFETY of PBI 4050 and its cognate PBI 1402 at varying dosages of 8, 12, 16 mg etc. PL once told me that he ascribed his own good health to a daily dose despite his stressful life living out of a suitcase in airports and hotel rooms.
The question that remained unanswered was always one of EFFICACY in mitigating fibrosis in sundry visceral organs. Of course many claims were made SUGGESTING efficacy using proof of concept studies, in vitro and animal models over the two decades that I have followed this company but NEVER once proven using a randomized placebo controlled Phase 3 trial. EVER!
Are they now, in order to achieve some aspirational end-point of efficacy, pushing the boundaries of dosage?
2) Commencing plasma collection from recovering Covid 19 patients.
The company holds most of the critical patents in PPPP and yet the way the announcement reads it appears that purification is being relegated to third parties. So what's the business model? Where's the monetization? Is LMNL now merely a collection agency?