Posted On: 07/29/2016 3:26:42 PM
Post# of 72443
Asked over there too:
Rare pediatric disease designation and potential priority review voucher.
As mentioned in a Dec 1 2015 PR, Kevetrin for retinoblastoma was awarded the Rare pediatric disease designation, which would allow CTIX to apply for a priority review voucher. This voucher has been valued at 350 million by AbbVie after their purchase of one from United Therapeutics.
Questions:
What is the earliest CTIX could apply for the voucher? Is it something done normally just prior to NDA?
I'm wondering if CTIX can leverage the voucher to avoid a capital raise and fund all current trials without dilution?
Or, is the PRV more valuable to the company in its intended form?
Rare pediatric disease designation and potential priority review voucher.
As mentioned in a Dec 1 2015 PR, Kevetrin for retinoblastoma was awarded the Rare pediatric disease designation, which would allow CTIX to apply for a priority review voucher. This voucher has been valued at 350 million by AbbVie after their purchase of one from United Therapeutics.
Questions:
What is the earliest CTIX could apply for the voucher? Is it something done normally just prior to NDA?
I'm wondering if CTIX can leverage the voucher to avoid a capital raise and fund all current trials without dilution?
Or, is the PRV more valuable to the company in its intended form?
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