From a business standpoint, if approved, Ryoncil will be the lifeline that Mesoblast requires to fund its operations for the foreseeable future... with Mesoblast taking on debt, those interest repayments will be growing for some time yet, but there will be a genuine on-going revenue source that Mesoblast can depend on to service that debt. So the program is not only going to save many children's lives from 2020... it will literally save Mesoblast's corporate life.
If Mesoblast does one day succeed commercially and realises its full potential... we will have to thank Ryoncil for making it all possible.
But having a look at what lies ahead in 2020 and 2021, we know that Mesoblast is already building its distribution network for paediatric aGHVD sufferers... with the large majority of patient concentration skewed to a dozen or so centres in the US.. this has allowed Mesoblast to potentially bring Ryoncil to the US market itself, thus retaining 100% of the sales proceeds (this is rare). All the centres in the trial already know the product and its efficacy was witnessed first hand... in fact, the practitioners themselves have been waiting for Ryoncil to be approved so they can immediately offer it to their patients. As far as I know, only those in the EAP and the phase 3 trial were offered Ryoncil... since the end of the phase 3 trial, patients have been deprived of it.
There is talk about what Ryoncil may also be used for... but in reality, those applications will take many more years to develop in the clinic. What we know for sure is that adult aGVHD is a natural label extension after the approval of Ryoncil. The adult aGHVD market is larger and less concentrated, as such a partner will be required for Mesoblast to unlock that revenue stream. The partner will need to fund a trial (or Mesoblast could go ahead and do it itself), and then take on the registration and marketing/distribution of the product. If Ryoncil is approved, this is a real no brainer- for a Pharma coy in the US to quickly snap this up.
What a year we have ahead for us... there will be ups and downs in the coming months, but ultimately the clinical trial results will define Mesoblast's trajectory in the foreseeable future. I have been waiting for this period in Mesoblast's corporate life for a very long time.
Some significant events in human history are well known and have had very public lead ups... just look at SpaceX, they are about to embark on some significant steps in advancing human's reach in this solar system. A paradigm shift in space travel. Other significant events in human history are less known and happen behind doors, or in this case.. in laboratories and clinics. In that same vein of thought, as others have already expressed a similar thought.. I echo how lucky I feel to be able to be part of Mesoblast's journey so far, as I have no doubt that if the upcoming trials are successful for chronic lower back pain and chronic heart failure (we will know results of both by mid 2020)... we are all here witnessing a paradigm shift in the pharmaceutical industry. How bloody fantastic that will be.
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