I don't think they are far off, but a lot will depend on when the confirmatory trial starts.
The confirmatory trial will take 6-9 months to recruit ... 12 months to run... 3 months to read-out... then give it 9-12 months to file the BLA.. then another 6 months for an outcome from the FDA.. all that adds up to around 2023/24 approval and sales, assuming the trial starts sometime late next year (realistic).
The read-outs in 2020 will however be very strong indicators on whether or not the program is worth multi-billions of dollars in a few years time.. or zero. So the price sensitive nature of these trial results will be significant.
The short term goal for MSB is to have a positive phase 3 read-out in the two phase 3 trials... but shortly behind that is the approval of its near-term revenue generator ... pediatric GVHD will be the cash-cow to fund the short to mid-term until CLBP and CHF are ready to hit the market ... but before they do, you can count on new MPC's being developed that will need to be funded in pre-clinicals, phase 1 and phase 2 trials.. which will then form the next generation of programs to push Mesoblast into 2030's (these treatments take at least 10 years to develop from conceptual to approved product).
The road to a multi-billion dollar company is not a short one.. and whilst we will be looking at an inflection point in 3-6 months time... it won't be the last one.. there will be many along the way.
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