Interesting comment re the adult trial awaiting BLA outcome....

Interesting comment re the adult trial awaiting BLA outcome. Firstly does not match with Mesoblast's timeline indications and change has not been communicated to market. Secondly, the FDA had indicated the adult trial could not progress until issues with potency assay had been resolved (or something similar ... sure someone can correct me). Does this mean that FDA have said to MSB the trial can't proceed until BLA outcome is determined ?
This feels really strange as I thought one of the alternate directions following original CRL was conducting an additional, well controlled trial in adults/children.

Feels like a loose/loose for MSB. Regardless of BLA outcome, just creates more delays in adult approval or god forbid, if we get another CRL on BLA again major delay.

I'm just hoping this direction reflects some "certainty" by MSB on BLA outcome and a broader strategy, rather than being told they can't proceed with the adult trial by FDA.

If FDA has told them adult trial can't proceed prior to BLA approval, it's a bit hypocritical as they are still happy for ongoing treatment of children in EAP.