Oct. 22 at 6:45 PM
$EDSA My take....P3 data now unblinded. Meaningful, statistical significant clinical benefit in the sickest patients. Cox regression HR, while not stat sig, shows time to improvement in the EB05 dosed patients. 28 day mortality likely not stat sig, hence why not presented, but trial was very small so understandable. Between this and the P2 substudy there's enough to somewhat "derisk" the EB05 program. For one, I don't think it has the blockbuster potential we may have initially envisioned, but since ARDS is high complexity with high mortality, any therapy that can improve clinical outcomes with a good safety profile can likely eventually get approval. The BARDA P2 will give us more insight and has hard endpoints. BARDA I think will fund a P3, and EB05 will likely be part of that. Long road ahead but just enough to keep me encouraged. Neutral.
