The major FDA justification was around Jakafi been available as...

The major FDA justification was around Jakafi been available as a treatment, Dr Kurtzberg was not happy.

What has happened since however confirms her opinion. The recent data generated by FDA gold standard trials has significantly cast further doubt on the Reach trials. Reach 1 the pivotal trial for GVHD created a control hypothesis of a 40% response . The gold standard failure shows the control had a 66% response in a very similar group. This variation would be put under review when the FDA reviewe our new application as current treatment options would also be looked at.
It could well be a very big problem for Incyte, the entire Reach trials are very open for mixed interpretation. That's not our problem to overcome.
Jakafi sale figures are impressive however a year on year growth of just 13 % suggests that the benefits may not outweigh the many adverse effects of the drug.
The FDA will be reviewing our BLA in a very different setting, there is no effective safe treatments available for children. (or adults ? ) They may even use Remestemcell-L as a reason to withdraw approval for Jakafi.

We should also question Incyte motivation to conduct trials in a indication that they already cover with Jakafi .
Perhaps they know that Jakafi is not all that it is made out to be.