Biotech Values

[jq1234]

>> how you finesse a drug that increases mortality in the long term versus this short term trial outcome.


Actual difference in SAEs between bard and placebo in BEACON that caused the trial being terminated early occurred quite early (3-4 weeks on bard) so it wasn't really long term effect. It was able to detect that type of difference only in very large trial of thousands of patients. I think it will be very difficult to detect in current small trial like 30 or 150 patients with Alport Syndrome.

Note, interestingly CARDINAL trial is using titration to 20 or 30mg, >= 20mg in BEACON.