# Europe's 51st State, EU GMP, and Building Before the Market Arrives ft. Michael Sassano

The expensive decision rarely looks intelligent before the market needs it.Operators can build for the regulations in front of them, or for the direction regulators are already moving. Across global medical cannabis mark...

- Episode: 311
- Published: 2026-11-06
- Guest: Michael Sassano (https://www.dimepodcast.com/guests/michael-sassano)
- Duration: 56 min
- Canonical: https://www.dimepodcast.com/episodes/europes-51st-state-eu-gmp-and-building-before-the-market-arrives-ft-michael-sassano
- Audio: https://afp-901980-injected.calisto.simplecastaudio.com/583052dc-8161-4a60-8c68-f486c33c8be9/episodes/122365b3-c2ff-4fcf-a89e-032494a3c8eb/audio/128/default.mp3?aid=rss_feed&awCollectionId=583052dc-8161-4a60-8c68-f486c33c8be9&awEpisodeId=122365b3-c2ff-4fcf-a89e-032494a3c8eb&feed=Vnrz0StH
- Written analysis: [The Most Expensive Decision Might Be the One You Didn't Make](https://www.dimepodcast.com/newsletter/the-most-expensive-decision-might-be-the-one-you-didnt-make)

## Show notes

The expensive decision rarely looks intelligent before the market needs it.

Operators can build for the regulations in front of them, or for the direction regulators are already moving. Across global medical cannabis markets, internal labs, stability programs, EU GMP manufacturing, and control of distribution are beginning to separate companies that can scale profitably from those that can only trade product.

This week we sit down with Michael Sassano

- Europe's 51st state
- Pharmaceutical discipline
- EBITDA before volume

Chapters

- 00:00 Schedule III and Europe
- 02:15 Europe as the 51st state
- 07:44 Building for pharmaceutical lead times
- 11:44 What EU GMP changes
- 16:14 Creativity inside the rulebook
- 19:40 Why pharma owns the lab
- 22:50 The economics of internal validation
- 26:34 Could the United States adopt this model
- 28:34 The EU GMP supply shortage
- 32:32 Regulators close the conversion loophole
- 35:23 Distribution consolidation begins
- 39:46 The missing vertical
- 43:25 A country by country strategy
- 46:37 What SOMAI will not do
- 49:42 Why extracts start with full bud
- 51:38 The rules become the moat
- 53:15 Europe as a totality of growth
- 55:21 Where to find Michael

Guest Links

- [SOMAÍ Pharmaceuticals website](https://www.somaipharma.eu/)
- [Michael Sassano / SOMAÍ on X](https://x.com/somaipharma/)
- [SOMAÍ on Instagram](https://instagram.com/somaipharma/)
- [SOMAÍ on LinkedIn](https://www.linkedin.com/company/somaipharma/)
- [SOMAÍ on Facebook](https://facebook.com/somaipharma/)

Our Links

- [The Dime Podcast — website](https://dimepodcast.com/)
- [Bryan Fields on X](https://x.com/BryanFields24)
- [The Dime on X](https://x.com/TheDime_8th)
- [The Dime on YouTube](https://www.youtube.com/channel/UCcck3tzBNXrJ1WJ8EtIVq1w)
- [The Dime on Instagram](https://www.instagram.com/thedime_8th)
- [Newton Insights — insights for extraction teams](https://www.newton-insights.com/)

Hosted by Simplecast, an AdsWizz company. See [pcm.adswizz.com](https://pcm.adswizz.com/) for information about our collection and use of personal data for advertising.

---

Markdown variant of any episode, guest, newsletter, answer or topic page on this site: add .md to its URL.
Site index: https://www.dimepodcast.com/llms.txt. Complete catalogue: https://www.dimepodcast.com/llms-full.txt