Essay · 2026-06-11 · 1450 words
The NextMed Settlement Is a Roadmap. Read It Before You Build the Next Telehealth Brand.
The FTC just handed the telehealth industry an inspection checklist.
Essay · 2026-06-11 · 1380 words
The Specific Pattern That Killed Five Biotech Programs I Personally Watched
The pattern was the same across five programs. In case you are running one of the next ones.
Essay · 2026-06-10 · 1410 words
Why Dallas Is Quietly Becoming the Right Place to Build FDA-Regulated Biotech
The Dallas-Fort Worth biotech ecosystem has been compounding for three decades.
Essay · 2026-06-09 · 1320 words
The 351 vs 361 Decision That Kills Most Exosome Programs
Why most exosome programs pick the wrong FDA pathway, and what the BLA route actually demands.
Exosome and mesenchymal stem cell derived extracellular vesicle products are not approved by the FDA for any indication. References here describe investment focus and published scientific literature. They do not describe an available treatment.
Essay · 2026-06-08 · 1280 words
Why Family Office Capital Fits FDA-Regulated Biotech Better Than Venture Money
A ten-year venture fund has to return capital on a schedule. The FDA does not care about your schedule.
Essay · 2026-06-07 · 1380 words
The Six Documentation Patterns That Show Up Before Federal Healthcare Enforcement
Every enforcement action I have served on involved a pattern visible eighteen to thirty-six months before.
Essay · 2026-06-12 · 1480 words
What Thirty Years of Operating in FDA-Regulated Healthcare Actually Taught Me
Five lessons I would tell my younger self if I could.