>> …looks like this would be a complement to Lomucin or the 2nd generation product GENR is developing for CF. GENR's products for CF are mucoregulators, while DYAX's product appears to be an anti-inflammatory.... <<
Is there any data to show that these two approaches can work synergistically?
>> Potential for orphan status for lomucin???
The FDA can theoretically issue multiple orphan-status designations for the same disease provided that the drugs work by substantially different mechanisms. Hence orphan status for Lomucin can’t be ruled out simply because DYAX has obtained orphan status. On the other hand, the burden will be higher for the second drug candidate in a given indication such as CF to obtain orphan status because the applicant for second orphan will likely have to show a clear benefit relative to the first orphan.
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