Two days ago I wrote about a drug that had been waiting 40 years for a better version of itself. Today the FDA said: not yet.
What the FDA Said
The CRL cited issues in two categories:
- Leachables data for product packaging
- Manufacturing deficiencies at CMO
- Product toxicology risk assessments
What the FDA Did Not Say
No additional clinical data requested.
This is the distinction that matters. The STRIVE-ON Phase 3 data — the 19% hypotension reduction, the 54% vs 8% dose compliance, the 29% better outcomes — none of that was questioned. The science held. The packaging didn't.
GRCE: -7.5%
The stock fell 7.5% on the day. Relatively muted for a CRL. The market read the same thing the letter said: this is fixable.
Grace Therapeutics plans to request a Type A meeting with FDA — the fastest meeting type, typically scheduled within 30 days — and resubmit. A CMC-only CRL with no clinical deficiency typically adds 6-12 months to the timeline, depending on the manufacturing remediation required.
Nimodipine has been the standard of care for vasospasm after subarachnoid hemorrhage since 1988. For 38 years, every neurointensivisit has managed the same problem: a drug that works but can't be given properly. Oral nimodipine through NG tubes. Crushing tablets. Aspiration risk. Hypotension from imprecise dosing.
GTx-104 solved all of that in the trial. Today, the FDA said the solution needs better packaging.
The 40-year wait adds another chapter. The science isn't the question. The manufacturing is.