
George Smiley
4K posts

George Smiley
@SmileysWord
Big fan of Munger. 1 of the 10. Not advice, not a professional. Seek help elsewhere.


Marty Makary was supposed to be one of President Donald Trump’s more conventional advisers. Instead, tension and controversy have clouded his tenure. Insiders say one more high-profile misstep could put the FDA commissioner’s job at risk. bloomberg.com/news/features/…

Spot on @Elijahjstacy - patients deserve simple clarity on the FDA’s true role. FDA approval is not an endorsement that a drug is “incredible” or the best on the market. It’s like a building permit: it simply confirms the therapy meets rigorous standards for safety and efficacy. Once that permit is granted & the drug reaches the market, FDA is only one of four layers of protection & decision-making. Patients can choose not to take it, doctors can decide not to prescribe it, and insurers can opt not to pay if it’s not right for that individual. Taking away choice because a drug isn’t “absolutely perfect” means patients and physicians never even get the option to consider it. Putting patients first means preserving every possible tool—so families and doctors can decide together.


"To those dedicated customers of Spirit, this one's for you." - Judge Young, as he avidly protected the dominance of the Big 4 airlines from competition. And so, Elizabeth Warren got her way. We now reap the consequences of her approach. Spirit Airlines will liquidate. Its planes will be absorbed into other players. The leaders will face less forceful competition. But fear not, @SenWarren will boldly and unreflectively learn nothing.


$qure $clpt New WSJ article on Makary, got ripped to pieces and really laid out the entire soap opera from start to finish. The whole article is pretty remarkable. Some parts of the article. “My sources say that patience with Dr. Makary is wearing thin among Republicans in Congress and White House officials. It’s time for Mr. Trump to pull the plug on the Makary show.” “Has any Trump administration official caused more political headaches for the president than Marty Makary? His Food and Drug Administration has turned into a soap opera, with real lives hanging in the balance.” Ditto a gene therapy by UniQure for the brutal neurodegenerative Huntington’s Disease, which slowed progression by 75% in a clinical trial. The FDA has demanded the company run another trial in which some patients would have to undergo sham brain surgery to serve as a control group. This is unethical. To add insult to injury, after Huntington’s patients blasted Dr. Makary and the FDA, a spokesperson for the agency derided them on social media as “the swamp.” In a CNBC interview, Dr. Makary claimed the drug had “no benefit” and that the agency was being “pressured to approve” it by industry. Dr. Makary is slicker than a pharmaceutical salesman. In public interviews, he boasts about accelerating access to gene therapies and rare-disease drugs, even as he and his deputies block them. When FDA rejections draw criticism, he uses “industry” as a bogeyman. Lawmakers aren’t buying his act.






A message for the #FDA from Katie Jackson 📧Bringing awareness of the unmet needs of the #HD / #JHD community as we continue to fight for a #cure/treatment💙💜💙Share these videos for #HDAwarenessMonth !~ #Help4HD #Day2 Submit video help4hd.org/events-1/hd-aw…


A message for the #FDA from Katie Jackson 📧Bringing awareness of the unmet needs of the #HD / #JHD community as we continue to fight for a #cure/treatment💙💜💙Share these videos for #HDAwarenessMonth !~ #Help4HD #Day2 Submit video help4hd.org/events-1/hd-aw…


🚨#BREAKING: Spirit Airlines are now expected to cease all operations around 3:00 a.m. ET on Saturday


6/I mentioned interstate on call. Yes it's controversial, and yes some will get hurt, but that's thinking too small imho. Rationalization is accelerating: like what we saw in Canada (3+ yrs ahead of US), defaults inside $IIPR portfolio, on top of the "capital suck" that's been going on since Q2 2022. And unlikely no new (net) capital is going into grow ops anytime soon (esp indoor). Rationalization will be massively accretive for some. CA (SB 1326 in fy'22) and other states prepared for state "off take" agreements...this falls into "common sense" bucket...and while we don't want to admit it this is how hemp-derived spread like wildfire.



