Ann: Update on BLA for Graft Versus Host Disease, page-769

Now would be a good time to actualy go back through Fridays annoucments.

Obviusly disapointed .

We have however had a win, MSB is now allowed to go on with trials. The trial desighn is still to be worked out however I would like to point out that through the good work of the Magic Concortium , todays trials can be far more meaningfull with a endpoints of 1 week than what would have been a 2 year endpoint 3 years ago. Small and very fast and still better than 3 years ago.

I would also point out that it was confermed that as a result of the last type A meeting MSB obtained a part win. We were allowed the opportunity to do the work that we have done and at that time the FDA considerd that may have been sufficient for approval.

If we again get in part a win , what would that win look like ? IMO approval for a limited population in children remains on the table.

45 days to go. !!