Sitting here on an ugly Sunday afternoon (wet & windy), I've got a bit of time to reflect - so here goes (free writing).
Where are we with our road to commercialisation?
Everything to do with the FDA has taken so long and the SP bleeds as a consequence of no news
So why the heck am I still invested in MSB?
It simply come down to the fact that I believe in the science, yes we missed several PEs, but did we miss them due to the product failing or poor trial design?
We can go around in circles discussing that, but I just want to focus on the closest product we have to commercialisation - Ryoncil.
Ryoncil is by far our smallest indication, but I would say our most important.
Get this over the line and MSB becomes a different investment proposition right away - heck, even the re-submission of the BLA would make MSB a different investment proposition.
With Ryoncil what have we got?
- A product that has been used in the real-world for 4 years+ (Japan)
- A product that has ODAC 9-1 vote
- A product that has received both Orphan drug designation and priority review
- A product that has been used for other treatments:
- UC & Chron's disease (with great early outcomes)
- Covid-19 ARDS - it's good enough for NIH to invest $50m into the trial
- A product that the lead investigator speak highly of, post the trial
- We have Philip R. Krause, M.D., Former FDA Deputy Chief for Vaccines, Joins Mesoblast Board to help with the CRL and the re-submission
Yes, the path is slow and annoying me
But, I have put the shares in the drawer and continue to wait!
GL MSB'ers - I'm looking forward to our days in the sun
(20min delay)