How come no Orphan Drug Designation? I think it only takes FDA about 60 days to grant it. The FDA database has 9 drugs granted the designation, so it is like a no-brainer for FDA to give Orphan Designation to a Fabry drug. Protalix should have applied for the designation while drug was in phase 1. Drug is about to start phase 3. So I think the phase 2 expenses do not count for tax credits. Why is company so slow?
Protalix is probably passing up on United States Orphan Drug Tax Credits. A company can get tax credit for 50% of expenses used for clinical trials in the United States. The tax credits start when granted Orphan Drug Designation. I think Protalix has a 10 year tax-free status in Israel. So if Protalix is going to pay United States taxes some time in the future, maybe Protalix should take advantage of the United States tax credits.