asco day 1… 20yrs in a row.

on where this fda is headed - this will probably be my last post on the big bull bear debate of what direction is this fda going to take because i think it's clear at this point that fda is 1) not materially disrupted, 2) continues to be supportive of regulatory flexibility, and

fun conversation with gordon at killik from the uk. open.spotify.com/episode/5DXvMg…

fda launching a new kind of priority review voucher with a 1-2month review. for programs that address health crisis, are innovative cure, unmet need, or national security manufacturing. that's a cool idea. fda.gov/news-events/pr…

i am a nicole verdun fan. as most gene therapy leaders will tell you, she translated peter marks vision on clinical regulatory flexibility into reality internally. she understood unmet need and urgency for patients with severe rare disease. like peter however, she largely

i really hate contributing to unfounded rumors or speculations, that said now i'm going to do just that in the hopes that folks can get closer to a satisfying answer for why nicole was let go. if you listen to yesterday's makary vinay podcast from about the 21 to 25min mark,

adam at stat thinks nicole's exit might of been due to a disagreement with vinay on capricor's review and more broadly on management style. he said interim is vijay kumar. statnews.com/2025/06/20/fda…

MABA

200% drug tariffs would likely mean drug companies would reshore all but the lowest cost parts of their supply chains (eg raw materials). given it usually takes 2-3x longer than the 1-1.5yrs proposed grace period to move things over why didn’t stocks drop today? probably

was a special moment to ring the bell this morning with the avidity team. this was one of my last relatively brief bod seats before i decided to focus as much as possible on investing. bods can be a hard job, but this one was the opposite bc of its leadership team. just

got to talk to akero ceo andrew cheng about mash and their drug efruxifermin. thanks andrew! youtube.com/watch?v=wILfqG…

first company to meet Trumps ask to give Americans DTC access at european like prices for some important drugs. wsj.com/health/pharma/…

$ghrs has been working with fda for the past couple years to open a US ind. in that time the company has completed all the way thru p2b in Europe, showing the largest benefit ever seen in treatment resistant depression. in addition this is a psychedelic, a priority for fda