Ann: Trading Halt, page-770

What’s going on with Mesoblast shares?
Mesoblast shares were put in a trading halt yesterday pending the release of the results of the U.S. Food and Drug Administration’s (FDA) review of its Biologics License Application (BLA) resubmission for remestemcel-L.

Remestemcel-L is a cellular therapy product that consists of cultured, cryopreserved mesenchymal stem cells derived from the bone marrow of healthy donors.

Mesoblast is hoping to gain approval for the treatment of children with steroid-refractory acute graft versus host disease (aGVHD). This is where donor cells (the graft) attack the organs and tissues of the patient who received them.

It has been a rocky road to this point, with the US FDA seemingly very reluctant to approve the treatment. However, Mesoblast has been working incredibly hard to prove that remestemcel-L is the treatment that steroid-refractory aGVHD sufferers need. And given that there are no current approved treatment options for children, the word need is an understatement.

Has the FDA made its decision?
The last update on the matter was that the US FDA would guarantee a decision on the company’s BLA resubmission by 2 August (US time). Is the lack of an update bad news?

That’s hard to say. But given that the US FDA has listed one approval on its website for 2 August, and not remestemcel-L, things are admittedly looking ominous for the company and its shareholders.

Could the company be preparing an announcement explaining the rejection and its next steps? It seems unlikely that a positive outcome announcement would take long to get out to the market.

However, it is only approaching 6pm in California, so the FDA could be working overtime and may not have even given its verdict yet.

For now, it is all speculation. All should be revealed tomorrow when Mesoblast makes it announcement. Here’s hoping for a good decision for shareholders and sufferers of steroid-refractory aGVHD.