fda approval, page-12

Share price is based on the market cap of the expected revenues. We are hugely discounted at the moment. pre crl we had a valuation I think of $2.5bn which equates to $3.07 taking into account the number of shares now on issue.
the market for sr a gvhd hasn't changed so the probability of approval should be the same as the last time, taking account time value of money etc. What has changed though is the covid trial, and other products that hang on from Msc products. Which are effectively 1st gen products and the ones acquired from Osiris. MPC products (are all mesoblast) and classed as the 2nd generation products which are far more potent and effective, are awaiting the phase 3 1 year trial to recommence and the heart.
i have stated from day dot, the market value of mesoblast will increase to $20bn USD based on the fact it will have proved that stem cells can get FDA approval and the doors/ flood gates will smash open. It's the 'halo' effect as silviu stated before. Don't forget every product has a market probability discount based on where it is in the product approval cycle.so when you pass phase 3, and let's not forget, remestemcel for sragvhd did pass it's primary endpoint regardless of what all the shortest say. Probability of approval passing a phase three trial jumps from 56.7% to a whopping 94.6%. We had all rights to think we would be approved. Only 54 cases in 1000 don't get approved! we didn't convince the FDA that we could manufacture product on a consistent basis and prove the invitro tests matches the in vivo tests and how it could be assessed. We resubmitted, received a letter stating the initial review of paperwork was in order, and they booked the factory inspection.
given my expectation of $20bn USD ~ $29.4 Aud means we still have a 31.85/ share potential sp. (Wow down from my $43/ share pre CRL from all the new shares issued, so yes dilution is real but still better than $0.50!)

thats my estimate and it is not financial advise.
https://www.statista.com/statistics/597850/drug-development-phases-probability-of-success-by-drug-classification-modality/

https://www.acsh.org/news/2020/06/11/clinical-trial-success-rates-phase-and-therapeutic-area-14845