MSB Trading - 2020, page-1509

Thank you for researching this, indeed we have to dig into semantics to understand where BLA filing stands at this point.

The final module will be filed during January, and Mesoblast will request an expedited FDA review of the BLA under the product candidate’s existing Fast Track designation. If approved, remestemcel-L is planned to be launched in the US in 2020.

The use of “will” instead of the conditional makes it plain to me that this solely depends at this stage on MSB. Of course, “Shall” would have shown more certainty.

The conditional in the last sentence refers to the Fast Track designation approval.

Hence, the filing of the last module appears to be a matter of form -MSB did not inform the market when previous modules were filed- more than substance while fast track approval is crucial or in other words “material”.

Of course we expect as shareholders a straightforward announcement at each and every step. However in this case maybe a surprise announcement of Fast Track approval would be more appropriate for the SP.