Ok, with a level head, these results were broadly as expected in terms of the down-regulation of several (6) biomarkers, and Zilosul did what Zilosul does in producing statistically significant pain and function scores at the 8 week mark. There were no AEs or safety concerns, as usual. This is all good news. It supports the MoA for Zilosul, and it shows consistency with what we've seen before. There are really no deep concerns coming out of this. I think now that we are cashed-up and this bar has been cleared, the 6-month readout becomes a very exciting prospect for the market. In that readout, we can (assuming all goes well) expect to report visible changes on MRI, that pain and function scores are still improved compared to placebo, and that this all correlates with down-regulation of biomarkers caused by Zilosul.
I would like to get a look at deeper data from this readout. I want to see what the results showed on things like NFkB, ADAMTS-5, CTX-II etc. Other things relating to P&F scores is that I get a real sense the 1-shot per week was a fizzer (no info), and the pain data lacked detail. I think we'd all like to see more data on the pain and function scores considering how vital this is to our investments.
I submitted a question by email regarding at what point (Day 56, 6 months, or 12 months) management have determined we will have enough to apply for TGA Provisional Approval. If I get an answer i'll post it.
All in all, it's a bar well cleared by the company. There's no reason for the share price to languish at these levels considering the promise of what is to come (as well as the CR being completed of course). I'm very, very excited about what the 6 months results will show, and was happy to hear that these results will be peer-reviewed and published. The conversations we can now have with the FDA via our Fast Track access should be deeply interesting for both sides. We are making ground to become history's first approved DMOAD, and if I were on the PAR management team I would be asking straight-out now what our pathway is to Accelerated Approval. If we pull out MRI's showing reduction in BML volume in this cohort come Q1 next year - things could really hot up.
Just a final note on the share price. The only thing I can envisage that keeps us down at these levels now is the thought that trial costs are blowing out and we'll require another CR before Christmas 2023. If the FDA ask us for further DM-related work prior to considering AA, that would mean additional costs to navigate. This means that a deal for MPS takes on massive meaning for the SP. If that were to happen in the next 12-months, we'd almost certainly be away. Pay attention to progress in that MPS area.
A good day. GLTAH.
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