Maddogx,
You asked;
So is orphan drug designation to follow soon after as well?
If you go back to the Shareholder Update dated April 15, 2013 you'll note Neuren highlighted this passage under the Fragile X Syndrome heading...
The results appear to be among the most compelling obtained with any molecule in a validated model that has been posited to predict the outcome of clinical studies in human patients. We believe that NNZ-2566 has the potential to represent a major breakthrough in this therapeutic area. Due to existing programs in Fragile X, the clinical and regulatory framework and assessment tools are already well-defined. It is possible that NNZ-2566 may qualify for Orphan Drug and Fast Track designation for this indication.
We know that Neuren has received Fast Track Designation for both Rett and now Fragile X Syndrome, so yes, it's possible that Orphan Drug Designation may very well be next.
Regards,
Tony
Maddogx,You asked;So is orphan drug designation to follow soon...
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