RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Rights offer , timing and Prometic Hi Stockbuphoon,
This is not meant to be a rebuttal but after reading your post I recalled a NR about the ongoing Alstrm trials and progress being made. Here is part of the release dated Dec 5, 2018.
According to PL the trial will be, small, quick and cheap! But we all know how much credibility PL had.
PROMETIC TO INITIATE PBI-4050 PIVOTAL PHASE 3 CLINICAL TRIAL IN ALSTRM SYNDROME ·
Clinical-regulatory pathway defined following recent meetings with regulatory authorities ·
Pivotal Phase 3 clinical trial design finalized to support regulatory submissions in the U.S. and Europe ·
Provides potential for faster route to regulatory approval with Alstrm syndrome ·
Opens an efficient route to market for PBI-4050 and potential to monetize Prometic’s second PRV LAVAL, QUEBEC, CANADA, – December 5, 2018 – Prometic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (“
Prometic” or the “
Corporation”) today confirmed its decision to formally pursue Alstrm syndrome (AS) as a clinical indication for PBI-4050 following positive feedback from its recent meetings with regulatory authorities. These meetings have provided Prometic with clear clinical and regulatory guidance, enabling the finalization of the design of a pivotal placebo-controlled Phase 3 clinical trial, including agreement on multiple endpoints including liver and cardiac fibrosis.
“
We are very excited that Alstrm syndrome could be the first approved clinical indication for our lead anti-fibrotic drug candidate, PBI-4050,” commented John Moran, M.D., Prometic’s Chief Medical Officer. “Our ongoing U.K. Phase 2 trial continues to generate encouraging safety and clinical activity data with patients averaging more than one year of drug exposure. We are confident in PBI-4050’s ability to reproduce similar positive clinical activity on specific key fibrotic clinical endpoints in the pivotal placebo-controlled Phase 3 study.”
The protocol for the Phase 3 clinical trial will be designed to meet expectations from both the U.S and EU regulatory agencies. The Corporation expects to start dosing AS subjects in the second quarter of 2019. The trial will enroll approximately 40 AS subjects in several countries to be randomized into 3 study arms, one receiving placebo and two receiving PBI-4050 (800 mg and 1200 mg) for 36 weeks. The placebo subjects would then be crossed over to one of the PBI-4050 arms for an additional 16 weeks of treatment. The endpoints will include liver steatosis measured by magnetic resonance imaging Fat Fraction assessment (MRI-PDFF), liver fibrosis measured by magnetic resonance elastography (MRE) and cardiac fibrosis measured by MRI.
Commenting on the cost of the trial, Pierre Laurin, Prometic’s President and Chief Executive Officer noted, “This will be a relatively small and quick trial, which can be undertaken within our financial means, and more importantly within the guidance on R&D spend given during our Q3 earnings call”. He added, “Alstrm Syndrome remains a very efficient route for us to potentially bring PBI-4050 quickly to approval, opening up both interesting commercial opportunities and the potential to monetize another PRV.” The FDA has granted a Rare Pediatric Disease Designation to PBI-4050 for the treatment of AS, thus making it potentially eligible to receive a priority review voucher (PRV) upon regulatory approval. In addition to the Rare Pediatric Disease Designation, PBI-4050 has also been granted Orphan Drug Designation by both the FDA and the EMA for the treatment of AS and of idiopathic pulmonary fibrosis