VRUS renal tox
a few points i gleaned from the 10K, some mitigating, others of concern. on the reassuring side:
1. all cases were reversible
2. the drug is not meant for chronic administration and tox may not appear in humans with dosing duration ultimately used clinically (although this could change if gunning for an all oral regimen, which surely would require longer dosing of the STATCs versus as add on to SOC)
3. there did appear to be a dose-dependent relationship (rather than idiosyncratic) - so they may find a sweet spot in terms of dosing even if the toxicity carries over in humans
less reassuring:
in the first monkey safety study they did not achieve a no observable AE level - i.e. the lowest dose cohort had toxicity, albeit milder (note this dose was still quite a bit higher than human dosing)
they DID achieve a NOAEL in the second study, but didn't note at which dose. knowing this would really help handicap odds of tox in humans imo, since doses did range around (both below and above) some of the doses currently being used in trials
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