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SVRA FDA Decision CRL · 2025-05-27

Refusal-to-File (CMC completeness), not a CRL

Price into the decision (T-120)

$3.26$2.28
Historical price action; green = local high, red = low/sell-off.

Decision facts

FDA decision date2025-05-27
Outcome✗ CRL⚠ label corrected
Decision-day move-31.7%
T-120 run-up (low→high)+18.0% ($1.94→$3.4)
CRL reasonRefusal-to-File (CMC completeness), not a CRL
Primary sourceView filing ↗
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