Ann: MSB Q3 Financial Results and Operational Highlights, page-133

Hi @stocksa

I dont think it was an accidental slip by Dr Rose at all. It's just a fact. All he said was that the potency assay had 'problems'. OK, well we all have 'problems', but I don't think that should be necessarily interpreted as a statement that time was wasted.

For example, Dr Rose didn't say that assay was being removed from the dossier. Nor did he say what MSB got out of its interactions with the FDA, especially OTAT, in resolving the 'problems'. For all we know, Mesoblast's IP 'moat' is getting bigger & the hurdle for the also-rans is getting higher with the FDA.

Nor for that matter did he discuss the differences in point of scientific focus of a potency assay directed at a 'trigger' - such as TNFalpha - and a potency assay directed at a biomarker of 'outcomes'. Both could, in my opinion, have evidentiary value in MSB's resubmission. They aren't necessarily inconsistent indicators of potency as far as I'm aware.

The deals will come to MSB inevitably IMO, & I agree with CEO Itescu - setting Mr Hester back on his heels - things need to be done properly on the resubmission.