A poorly run CR with the residual 122m in shares given substantially to instos/SI's mates to flip for an easy profit means the price will be held back to around 35c or so for the next couple of weeks to a month. The fact that this only got completed on the FDA Supports Accelerated Approval Pathway for Heart Failure tagline is fortuitous and speaks to the mismanagement of the CR.
Now as this CHF announcement did not get accompanied with any guidance from SI on the FDA meeting or the CHF program in general (which is extremely disappointing) we are left picking up breadcrumbs.
Whilst some posters are bullish on the "FDA supports Accelerated Approval" tagline, I fear that the through FDA meetings since the initial results release in December 2020 of the Dream-HF trial (gee that's a long time ago), the FDA has effectively rejected AA for the earlier stage of CHF Class II/III cohort (~6.5m patients per year in US) to the later stage CHF Class IV with LVAD population (~2,000 patients per year in US).
If the FDA said Class II/III with ischemia/diabetes was on the table for AA through these meetings then this would have been announced as this would add multiples to the current share price. Let me expand. My back of the envelope calculation has the LVAD population at 1,000x smaller than the pre-LVAD cohort (LVEF < 40% and ischemic and/or diabetic) of approximately 2,000,000 in the US alone. Off this ~2,000,000 cohort, I am unsure how many treatments would be performed as many could be uninsured or unable to pay for the treatment, whereas the LVAD population conversion would be much higher as the LVAD implantation cost is not insignificant.
Pricing then becomes key. I don't believe there has been any direct guidance on pricing of the Revascor therapy and I would appreciate expertise on this point. I have in my notes that Edison's (remember those guys?) pricing assumption was USD$50k per treatment (can't confirm anywhere though) which could leave the LVAD cohort revenue as a much smaller piece of the hopeful CHF pie. If the estimated pricing gets up to USD$500k then that changes the NPV drastically.
Therefore, I have substantially removed any expectations of a heart partnership even on accelerated approval for LVADs. With only a max of 2,000 patients per year, I'm not even sure it's worth it for big pharma companies to partner up with MSB if the Class II/III is off the table for now.
(20min delay)