Jeff, Good call! >>I still believe it will get fast track status when it is filed.<<
On March 8, when I asked IR if Targretin for CTCL had orphan status,
their email reply was, "We do not at this time have Orphan Drug Status."
To me, that implied they were still trying to obtain it.
But by mid-June, I gave up hoping for success
-- mis-guessing FDA's timing in such matters!
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Orphan status must be obtained BEFORE the NDA is filed.
So, folks, Ligand's filing was NOT "delayed."
Rather, they were waiting for that orphan designation, a fiscally responsible decision
-- which gives them benefits beyond the 7-year exclusivity
-- including nice financial perks.
The money saved by Orphan designation improves Ligand's financial health.
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From the FDA website, the orphan drug Q&A section:
fda.gov
Are orphan drugs exempt from FDA User Fees?
Legislation reauthorizing FDA's user fees also created an exemption for orphan products from fees imposed when an application to approve the product for marketing is submitted.
Are orphan products approved faster than other drugs?
Historically the approval time for orphan products as a group has been considerably shorter than the approval time for all drugs. This is due to the fact that many orphan products receive expedited review because they are for serious or life-threatening disease.
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Does anyone understand the tax credit advantage for orphan drugs?
I understand that a sponsor may claim 50% of clinical trial costs (for that indication) as a credit against taxes owed - with carry forwards.
But reading the law at fda.gov
I'm not sure Ligand got orphan designation in time to take advantage of this one.
Can anyone provide information on this item?
Regards,
Cheryl |
