Replies to post #78019 on Biotech Values

[mcbio]

Re: VRUS R7128 preclinical tox

I think the first monkey tox study was stopped as the preliminary results indicated outward signs of clinical toxicity, but after a detailed examination of the 13 week data, and of the second monkey tox study which was a 13-week one, they made the comment about the NOAEL in monkeys being well bellow 600mg/kg/day.

One other point I forgot to mention before genisi: I assume the comments about no observable adverse events level (NOAEL) in monkeys being well below 600mg/kg/day is meant to read at 600 or below. Unless I'm reading this wrong, a figure well below a certain dose implies there could have been toxicity concerns right around and just below the stated dose. I.e., it's better if NOAEL occurs at higher doses as opposed to lower.

Regardless, the 1000 mg BID dose in the Phase 2b of R7128 should be quite telling of safety since that dose appears to be well above the NOAEL in monkeys at a similar treatment duration.

[dewophile]

VRUS
i presume you meant well above 600mg/kg/d?

regardless I agree - the fact the FDA let them go ahead with the 1000BID dose is in and of itself perhaps the most reassuring item