The article is from The Fool. It lists many insights from Bell Potter who always seem to have the intel on Mesoblast and be ahead of the game. Yes, they've lifted their 12 month price target to $1.40 but the section I found most interesting were in relation to the Adult Trial:
Surmising the resubmission of the BLA is likely to take place in mid June with the potential of a 60 day approval timeline being mid August. Not for certain though. Could possibly still be a 6 month approval timeline?
The second clear observation is that the adult trial which had been communicated by the company to start this quarter has been postponed pending the outcome of BLA. Therefore wouldn't start until after August at the earliest, if at all. Is it possible that they're only going to run the adult trial if the resubmission fails? Clearly they're going for full approval for Ryoncil with kids and potentially looking to use label extension to treat the adults? MSB have a very strong alliance with BMT CTN who conduct 80% of the allogenic bone marrow transplants in the US. They attended the type A meeting with Meso & FDA in September 2023. They've seen Ryoncil being used on adults through the BMT CTN network for years now under emergency use, with tremendous results. It's not going to be a hard sell to get Ryoncil extended to Adults through this strong connection with the Network.
With the >12 yr old market being 5x the size of <12 yr olds is it possible that by mid August (if Ryoncil is approved for kids) we could, in effect have the whole sr-avghd market via this one approval? Interested in other's thoughts. The article is worth looking up.
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2024 Here we go again., page-447
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