Biotech Values

[DewDiligence]

OCRX—So is this game over or do you think they have a chance in Phase 3 to turn this around?

They still have a chance because OCR-002 is clearly an active agent, and the STOP-HE results likely would've been better if they had given patients a higher dose.

However, the loss of momentum from STOP-HE is a big setback in practical terms for a company like OCRX with modest financial resources.

The biggest problem, IMO, is not that the primary endpoint was missed (p=0.129), but rather that the HR on the primary endpoint was a modest 0.80. If the HR on the primary endpoint had been, say, 0.60, OCRX would be in much better shape even if the primary endpoint had been missed. A trial with HR=0.60 (instead of HR=0.80) on the primary endpoint would've had a decent chance to serve as one of the two pivotal trials for FDA approval in this orphan indication, while the actual STOP-HE trial has little such chance, IMO.