On July 10, 2025, the FDA did something unprecedented: it dropped over 200 Complete Response Letters (CRLs) for public viewing—documents once considered trade secret goldmines. In this episode, host Ray Miller (Partner, DLA Piper) dives deep into what this massive disclosure means for biopharma innovators, IP strategists, and investors.

Is this bold new transparency a regulatory revolution—or a compliance nightmare?

We unpack:

• Why CRLs are so sensitive—and why their release matters
• The collision course between radical transparency and trade secret law
• What this means for patent filings, investor communications, and litigation exposure
• How AI is helping lawyers and companies mine this data for insights and avoid costly missteps
• The future of hybrid IP strategies in the post-CRL publication world

Whether you're a GC, VC, scientist, or simply regulatory-curious, this episode explores the fine line between disclosure and disaster—and how you can turn this shake-up into strategic advantage.

R² IP: Where legal nuance meets biotech strategy—with just enough humor to make it go down smooth.

https://www.raysretreat.com/s/Rays-Retreat-2025-Think-Piece-on-Radical-Transparency-FDAs-Complete-Response-Letter-Release-Challeng.pdf

Radical Transparency: FDA’s Complete Response Letter Release Challenges Trade Secret Norms