Nov. 14 at 5:24 PM
$ALDX Based on all available information, this is strongly pointing toward approval. The CRL issues were fully addressed, the primary endpoint was hit with a prespecified p-value of 0.002, and even the treatment-chamber-only post-hoc analysis stayed solidly significant. Everything lines up.
And honestly, the RASP-inhibitor approach feels like a bit of a “holy grail” in medicine. It delivers immunomodulatory effects similar to corticosteroids — but without the feared steroid side effects. That means potentially broad applicability across multiple inflammatory and immune-mediated diseases.
If reproxalap gets approved, this could be the beginning of something much bigger.