" Phase 2 Drugs and the FDA Commissioner's National Priority Voucher ":
Bizengri (zenocutuzumab): This is one of the most prominent examples of a Phase 2 drug that received the voucher and a rapid approval from a Phase 2 trial. Based on data from their Phase 2 "eNRGy" trial, the developer (Partner Therapeutics) received a FDA Commissioner’s Voucher. This allowed them to bypass traditional wait times, leading to its rapid approval for NRG1+ cholangiocarcinoma. The drug's expansion into cholangiocarcinoma was rapidly fast-tracked via the FDA's Commissioner's National Priority Voucher pilot program.
The rapid Phase 2 approval described above is despite Bizengri having a "Black Box Safety Warning", the most serious warning the FDA has in its toolbox. In addition to the Black Box designation, the FDA also lists three other Warnings and Precautions that are considered clinically severe for Bizengri.
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By now we're all familiar with Leronlimab's reported (impeccable) safety, which may help further expedite things when the FDA assesses Leron.
It's strange how the above "Bizengri" example (of a Phase 2 drug receiving a voucher and rapid approval) was omitted by the individual who loves to constantly broadcast negativity and FUD regarding Leronlimab and CYDY.
Let me guess; this person either won't respond, or will shift the goalposts and/or nitpick some granular piece of information that they'll amplify to support their super-bearish timeline. So let me get ahead of it; as referenced above, it was an approval for label expansion. It's still PHASE 2 + VOUCHER + RAPID APPROVAL. Literally the exact scenario you said never happened before and won't happen in the future. Except it already happened .
We've all heard you loud and clear; your opinion (the one that you repeat ad nauseam) is that no approval for Leronlimab is forthcoming for many years. You're on the record. I'll go on the record too; I believe Leronlimab will receive an approval far sooner than anyone can imagine. In fact, I predict it will happen at an unprecedented speed.
Now how about we all move on to a new topic?
https://www.youtube.com/watch?v=nvlTJrNJ5lA
____________________________________
#STOP_THE_FUD!
____________________________________
I remain... #BULLISH
#LERONLIMAB #CYDY #CCR5 #SAVINGLIVES #DRJAY #DRKASI #DRPESTELL #OPENLABEL #ctDNA #CRC #COLDTOHOT #ALZ #mTNBC #IMPECCABLE_SAFETY #MAKINGWAVES #OUTERLIMITS #OPENWATERS
Bizengri (zenocutuzumab): This is one of the most prominent examples of a Phase 2 drug that received the voucher and a rapid approval from a Phase 2 trial. Based on data from their Phase 2 "eNRGy" trial, the developer (Partner Therapeutics) received a FDA Commissioner’s Voucher. This allowed them to bypass traditional wait times, leading to its rapid approval for NRG1+ cholangiocarcinoma. The drug's expansion into cholangiocarcinoma was rapidly fast-tracked via the FDA's Commissioner's National Priority Voucher pilot program.
The rapid Phase 2 approval described above is despite Bizengri having a "Black Box Safety Warning", the most serious warning the FDA has in its toolbox. In addition to the Black Box designation, the FDA also lists three other Warnings and Precautions that are considered clinically severe for Bizengri.
_____________________________________
By now we're all familiar with Leronlimab's reported (impeccable) safety, which may help further expedite things when the FDA assesses Leron.
It's strange how the above "Bizengri" example (of a Phase 2 drug receiving a voucher and rapid approval) was omitted by the individual who loves to constantly broadcast negativity and FUD regarding Leronlimab and CYDY.
Let me guess; this person either won't respond, or will shift the goalposts and/or nitpick some granular piece of information that they'll amplify to support their super-bearish timeline. So let me get ahead of it; as referenced above, it was an approval for label expansion. It's still PHASE 2 + VOUCHER + RAPID APPROVAL. Literally the exact scenario you said never happened before and won't happen in the future. Except it already happened .
We've all heard you loud and clear; your opinion (the one that you repeat ad nauseam) is that no approval for Leronlimab is forthcoming for many years. You're on the record. I'll go on the record too; I believe Leronlimab will receive an approval far sooner than anyone can imagine. In fact, I predict it will happen at an unprecedented speed.
Now how about we all move on to a new topic?
https://www.youtube.com/watch?v=nvlTJrNJ5lA
____________________________________
#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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