Post by
Viking2233 on Jul 24, 2023 11:00am
Update
Last week Arch management did a webinar review of the past 12 months. The webinar was useful in the sense that it highlighted the milestones achieved in the past 12 months and outlined the future direction and goals. It was clear that the company has significantly de-risked the process to final approval. My take was that management was in agreement that tge current share price was very undervalued compared to similar staged peers but they did not appear to be concerned. I belueve they were surprised in the lack of new buying with past 3 news releases but appeared confident in the upcoming FDA approved phase 2 trial.
The took a number of questions from shareholders and some were difficult questions but did not shy away. Many current shareholders are frustrated with the legth of time it is taking for the 3rd party review of phase 2 data that the analyst frim Raymond James is waiting for. Management explained this was out of their control and are also surprised in the legth of time but made it abundantly clear that the data has been released and reviewed by both Health Canada and FDA and further explained that they were approved for a phase 3 CATCO trial during covid but vould not recruit enough patients for the trial. The fact they were approved for CATCO trial says a lot about their drug and science. The fact they recently obtained FDA approval for new phase 2 AKI trial plus new $5M grant from Federal Government further endorses the data.
Management was very adamant that there will be no surprises in the 3rd party review as the data has been released. I believe they are a bit surprised that this is a moot point for the analyst based on facts above. My take is even when the 3rd party data is released, I am not dure what impact it will gave as the results are already known. It may satisfy the analyst who might be more comfortable to increase his target price and rating.
The new FDA phase 2 AKI trial is scheduled to start in the fall of 2023 and this will open many doors if we see positive results which management belueves will be the case. Our phase 2 covid trial was done on small number but the new FDA phase AKI trial is to target 240 patients. There are no current treatments or competition for AKI so if the redults are positive and compelling this could open the door for fast tracking. Management in my opinion is prepared for that and has manufacuring in place and stockpile of the drug. I believe the markets have over looked or ignored this.
Management aldo made a point to
outline their two key strategic advisors who are connected to big pharma Novo Nordisk & Pfizer. These teo bug pharma are flush with cash and desparately searching for new drugs for their pipeline.