Tuesday, October 21, 2014 1:39:25 PM
from Mast IR.....
"Thank you for the message, please accept my apologies for the delay in responding but I am currently on vacation with intermittent connectivity. We elected to withdraw our application for EU orphan drug designation of MST-188 in acute limb ischemia (ALI) for now, in order to include additional clinical data from our on-going Phase 2 study of MST-188 in patients with ALI. We plan to resubmit our application after this study. As you are more than likely aware, MST-188 was granted orphan drug designation for ALI in the U.S. last year. Moreover, the benefits of orphan designation status are largely post-phase 3, thus we have plenty of time to secure the EU orphan designation."
Please let me know if you have any further questions.
Best,
Ioana
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