Hi- It seems that Mesoblast expects FDA approval within the next 2 years, but I don't know for what indication as it seems to treat multiple illnesses. From this article: http://www.businesstimes.com.sg/premium/singapore/stem-cell-therapy-firm-set-manufacturing-plants-here-20140529
STEM cell therapy firm Mesoblast plans to set up manufacturing plants here, in anticipation that its flagship product, Prochymal, will get approval from the US Food and Drug Administration (FDA) in the next two years.
This comes also as the Australia-based company prepares for new product launches in the US and other markets over the next few years.
A product awaiting full approval is Prochymal, which Mesoblast claims helps to more than double the survival rate of patients suffering from complications after receiving tissue transplants from donors, also known as graft versus host disease.
Mesoblast acquired Prochymal last year after buying over Osiris Therapeutics' stem cell unit.
It seems that the Phase III trial for Crohn's is ongoing. I don't see any information why it is taking so long though....
Post Edited (Bareket1) : 6/2/2014 10:30:22 AM (GMT-6)