MSB Trading - Aug 2020 on, page-679

AFR

Mesoblast shares slump ahead of FDA meeting

William McInnes

Mesoblast's shares have slumped in early trade ahead of a scheduled meeting with the US Food and Drug Administration on Thursday.

Its shares are down 13.1 per cent to $4.23, having dropped as much as 19 per cent earlier.

In a briefing note released by the FDA ahead of the meeting, the Oncologic Drugs Advisory Committee (ODAC) appears to have cast some doubt on Mesoblast's Remestemcel-L candidate.

"FDA’s position is that the product attributes the Applicant has identified as related to potency and activity, however, do not have a demonstrated relationship to the clinical performance of specific DP lots, and that the product’s proposed immunomodulatory mechanism of action has not been demonstrated in vivo in study subjects receiving remestemcel-L," it said.

"Without a demonstrated relationship with clinical effectiveness and/or in vivo potency/activity, controlling these CQAs may not be sufficient to ensure the manufacturing process consistently produces remestemcel-L lots of acceptable quality."