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Seriously? So for example the covid vaccine should have been approved in 1 month based on the crisis response or because mRNA approach is transformative, or if it could be made in the US. I feel so much safer knowing a reckless FDA won't be a problem now.
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I’m trying to understand your point. This drug is for people with metastasized cancer. I’m comfortable with fast tracking it, because what’s exactly the harm of letting desperate people try something that seems likely to help a lot?

Also, the risk profile is sort of the inverse of a covid vaccine where everyone was supposed to take it.

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The FDA article lists 5 reasons the pilot of the pilot is only for the non controversial one that is not even listed in a way that maximizes its risk/benefit requirements.
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Comparing the acceleration of FDA approvals for non-contagious terminal diseases like PDAC to development of COVID vaccines is flawed on so many levels. You make it sound as though this was just cooked up in some desert meth lab RV over a weekend, and the FDA just rubber-stamped after a cursory glance at the data. The Phase 1/2 study first exploring daraxonrasib (RMC-6236) was posted on clinicaltrials.gov in May 2022; this trial enrolled 754 patients [0]. The RASolute 302 study this approval is based on was first posted to clinicaltrials.gov in October 2024; this trial enrolled 500 patients [1]. Nevermind the years of preclinical discovery and translational work that had to precede human studies.

As you can see from the control arm showing 6.7mo of survival on standard of care chemotherapy, these patients have a very poor prognosis. Is this a cure? No. Does it buy time to see your child graduate, get married, or give birth? Quite possibly.

If you ever have the opportunity to work behind the scenes within the pharma industry and/or FDA, you'd be astonished that anything ever gets approved with all the red tape and complexity along the way. Medicine is not software - it operates within the black box of human biology which is incredibly nuanced from patient to patient.

Like many who have shared personal stories in this thread, I've lost friends to PDAC. It is a terrible disease often driven by a mutated oncogene (KRAS). Many cancers have KRAS-driven subtypes (lung, colorectal, low-grade serous ovarian, etc). The clinical platform and pipeline at RevMed has potential to address many other cancers. They have next-gen RAS agents that could be even more impactful.

For those curious, RevMed posted a solid summary of the approval on their IR site [2]

[0] https://clinicaltrials.gov/study/NCT05379985?tab=researcher [1] https://clinicaltrials.gov/study/NCT06625320?tab=researcher [2]https://ir.revmed.com/static-files/0f7e4612-ad39-4c87-b266-8...

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Good post but the whole "buy time to see your child graduate, get married or give birth" trope is quite frankly very annoying.

Older people have more going on, and more reasons to live, than whatever the next generations are up to. Even if we have children.

I had curative (hopefully, presumably) kidney cancer surgery 11 years ago. So far I've enjoyed travelling, socializing, working, coding, chess and other hobbies in the extra time I've been granted and I hope for decades more time to enjoy life. I don't have children. never aspired to it.

Sorry for the rant!

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