To frame its trial results positively, Compass Pathways used less stringent definitions for key endpoints. It defined 'clinically meaningful reduction' and 'remission' at levels below the common standard, a tactic that calls into question the true magnitude of the drug's benefit.
The FDA's quick reversal on reviewing Moderna's flu shot is not a simple policy change. It likely signals deep internal disagreements within the agency, potentially exacerbated by political pressure, which seeks to minimize vaccine-related news ahead of elections.
Compass Pathways' stock surged despite its depression drug showing a smaller-than-expected effect. Investors grade on a curve, recognizing the difficulty of psychiatric trials and prioritizing statistically significant results over the magnitude of benefit, given the commercial success of similar drugs.
Regulators cracked down on Hims not solely for selling compounded GLP-1s, but because of a confluence of provocative actions. A highly visible Super Bowl ad and a bold oral pill launch created a perception of 'thumbing the nose' at regulators and Novo Nordisk, forcing a decisive response.
Hims' expansion into selling non-FDA-approved multi-cancer early detection tests raises concerns among researchers. Offering these to its relatively young, low-risk user base could lead to false positives, triggering unnecessary and costly 'diagnostic odysseys' for patients who are merely worried.
Direct-to-consumer telehealth companies like Hims achieve rapid growth via a vertically integrated model of marketing, medical groups, and pharmacies. This structure allows them to generate revenue from selling medicines, a more scalable business than relying on fees from the practice of medicine alone.