Jan. 8 at 9:16 PM
$NGEN
Used AI help for this.
FDA wording comparison (pre-Accelerated Approval context):
NervGen says the FDA “confirmed multiple regulatory pathways are available to support approval” and is planning an End-of-Phase 2 meeting to align on registration.
That language is STRONGER than what many biotechs used before AA.
Examples:
• Sarepta (pre-Exondys 51): “potential pathways,” “surrogate endpoints may be considered”
• Amylyx (pre-ALS approval): “continued dialogue,” “additional data requested”
• Typical weak language: “FDA expressed concerns,” “additional studies required”
What stands out with NGEN:
-“support approval” (not just continue development)
- “multiple pathways” (regulatory flexibility acknowledged)
- EOP2 framed around registration, not exploration
This is careful-positive FDA language, not promotional. It doesn’t guarantee AA, but it does suggest FDA openness and narrowing regulatory risk. Biotechs are heavily constrained in what they can say about FDA interactions.
