Its Over, page-5029

Biotech was always going to be "hero or zero", and if it was zero, the company usually would tilt a different angle to the trial or test rather than admit failure.

Biotech is a good sector to be in , just need to be wary that you could be up a lot over a certain period and because of such announcement, it falls dramatically, so allocate capital wisely.

Not one to put your "food on the table" money, if you do, you'd want to exit partially when up along the way.

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."