Replies to post #208309 on Biotech Values

[kris_kade]

Per company's CC soon after the data was released, they indicated that patients who died were very ill.

Still doesn't explain the higher rate on the Tx arm

[iwfal]

AUPH

Though Voclosporin showed some impressive efficacy results in their phase 11 trial

Nope - they showed 'efficacy' in a proteinurea related endpoint. This is NOT the same as real patient benefit since the move to ESRD is based primarily on GFR, not proteinurea (and I suspect most of the sequelae also come from GFR issues, not proteinurea - although that is somewhat speculative). See #msg-125668735 and the thread that comes from it.

PS I predicted that they had a GFR problem well before I found it. It was very predictable.

SAE'S were another matter with 13 deaths reported

Who knows - they aren't being remotely transparent. In a recent PR they said:

"Adverse events were higher in the voclosporin treatment arms versus the control arm, which is consistent with increased immunosuppression. The overall mortality rate was similar to other recent global LN trials; all were considered unrelated to the study drug."

Adverse events were higher - that sounds not-so-bad, right? Nothing like an extra 13 Grade 5 SAE.