Someone posted the following regarding Leronlimab's potential approval timeline:
" the national voucher program has awarded 100% of its drug development vouchers to companies with a p3 underway. a couple may have had p3 JUST underway but 100% were at that juncture."
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However the above post is deceitful as Phase 3 is NOT a necessity. In fact, quite the opposite:
-The FDA's Commissioner's National Priority Voucher (CNPV) pilot program has awarded vouchers to drugs and products that were not in Phase 3, nor entering Phase 3. Some were based on intermediate endpoints from earlier trials. The program focuses on accelerating review times (1-2 months) for therapies addressing major U.S. health priorities.
- Because the program aims to incentivize national priorities like breakthrough innovations, the "stage of development" is not a barrier to entry.
-A drug does not have to be entering Phase 3 to receive the Commissioner’s National Priority Voucher (CNPV).
-In fact, one of the defining features of this program is its flexibility across the development lifecycle. Unlike some traditional pathways that focus strictly on the final submission stage, the CNPV can be awarded much earlier.
When Can a Drug Receive a CNPV?
-Any Stage of Development. The FDA has explicitly stated that a voucher may be applied at any stage of product development.
_____________________________________
Relevant info regarding the FDA Commissioner's National Priority Voucher (CNPV) Program :
https://www.fda.gov/industry/commissioners-na...ot-program
https://www.fda.gov/news-events/press-announc...ot-program
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#STOP_THE_FUD!
____________________________________
I remain... #BULLISH
#LERONLIMAB #CYDY #CCR5 #SAVINGLIVES #DRJAY #DRKASI #DRPESTELL #OPENLABEL #ctDNA #CRC #COLDTOHOT #ALZ #mTNBC #IMPECCABLE_SAFETY #MAKINGWAVES #OUTERLIMITS #OPENWATERS
" the national voucher program has awarded 100% of its drug development vouchers to companies with a p3 underway. a couple may have had p3 JUST underway but 100% were at that juncture."
_____________________________________
However the above post is deceitful as Phase 3 is NOT a necessity. In fact, quite the opposite:
-The FDA's Commissioner's National Priority Voucher (CNPV) pilot program has awarded vouchers to drugs and products that were not in Phase 3, nor entering Phase 3. Some were based on intermediate endpoints from earlier trials. The program focuses on accelerating review times (1-2 months) for therapies addressing major U.S. health priorities.
- Because the program aims to incentivize national priorities like breakthrough innovations, the "stage of development" is not a barrier to entry.
-A drug does not have to be entering Phase 3 to receive the Commissioner’s National Priority Voucher (CNPV).
-In fact, one of the defining features of this program is its flexibility across the development lifecycle. Unlike some traditional pathways that focus strictly on the final submission stage, the CNPV can be awarded much earlier.
When Can a Drug Receive a CNPV?
-Any Stage of Development. The FDA has explicitly stated that a voucher may be applied at any stage of product development.
_____________________________________
Relevant info regarding the FDA Commissioner's National Priority Voucher (CNPV) Program :
https://www.fda.gov/industry/commissioners-na...ot-program
https://www.fda.gov/news-events/press-announc...ot-program
____________________________________
#STOP_THE_FUD!
____________________________________
I remain... #BULLISH
#LERONLIMAB #CYDY #CCR5 #SAVINGLIVES #DRJAY #DRKASI #DRPESTELL #OPENLABEL #ctDNA #CRC #COLDTOHOT #ALZ #mTNBC #IMPECCABLE_SAFETY #MAKINGWAVES #OUTERLIMITS #OPENWATERS
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