The expedited actions of this (new) FDA, led by its reformist commissioner Dr. Marty Makary, do not align with the pedantic, incredibly bearish, overly pessimistic, absolute worst-case scenario timelines one particular poster constantly broadcasts on this board. For context:
Since arriving at the FDA in April, Makary has repeatedly told FDA staff they need to “challenge assumptions” and rethink procedures. In a medical journal commentary published last week, Makary suggested the agency could conduct “rapid or instant reviews”
Source: https://apnews.com/article/fda-drugs-makary-t...f2c6361f33
As an example of accelerated drug approvals, Makary noted that the FDA approved Zongertinib in only 44 days , a drug that treats HER2-mutant small-cell lung cancer.
Source: https://insurancenewsnet.com/innarticle/fda-c...g-approval
TWO DAYS after receiving the application, FDA greenlit the new pancreatic cancer drug daraxonrasib for expanded access. This drug has also been granted a national priority voucher, which means "a full application could be reviewed in a matter of weeks instead of 10-12 months".
Source: https://x.com/DrMakaryFDA/status/2050350802338816096
Open-label trials frequently lead to faster drug approvals, particularly in oncology and rare diseases.
Source: Google Gemini (and common sense)
#STOP_THE_FUD!
______________________________________
I remain... #BULLISH
#LERONLIMAB #CYDY #CCR5 #SAVINGLIVES #DRJAY #DRKASI #DRPESTELL #OPENLABEL #ctDNA #CRC #COLDTOHOT #ALZ #mTNBC #IMPECCABLE_SAFETY #MAKINGWAVES #OUTERLIMITS #OPENWATERS
Since arriving at the FDA in April, Makary has repeatedly told FDA staff they need to “challenge assumptions” and rethink procedures. In a medical journal commentary published last week, Makary suggested the agency could conduct “rapid or instant reviews”
Source: https://apnews.com/article/fda-drugs-makary-t...f2c6361f33
As an example of accelerated drug approvals, Makary noted that the FDA approved Zongertinib in only 44 days , a drug that treats HER2-mutant small-cell lung cancer.
Source: https://insurancenewsnet.com/innarticle/fda-c...g-approval
TWO DAYS after receiving the application, FDA greenlit the new pancreatic cancer drug daraxonrasib for expanded access. This drug has also been granted a national priority voucher, which means "a full application could be reviewed in a matter of weeks instead of 10-12 months".
Source: https://x.com/DrMakaryFDA/status/2050350802338816096
Open-label trials frequently lead to faster drug approvals, particularly in oncology and rare diseases.
Source: Google Gemini (and common sense)
#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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