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Biotech / Medical : Regeneron Pharmaceuticals -- Ignore unavailable to you. Want to Upgrade?


To: Biomaven who wrote (882)10/8/2003 12:12:09 PM
From: keokalani'nui  Read Replies (1) | Respond to of 3557
 
I haven't listened to the CC, so sorry to post out of ignorance.

What doesn't sound right to me is that the P1 max dose (800mcg/kg) showed 49% reduction of >50% CRP and 74% reduction >20% CRP and 50% reduction ACR20. The differences between placebo were consistently greater than just reported P2. Maybe safety says they can push it higher, but did company make a convinving case that P2 dose response argues for going above 100mg?



To: Biomaven who wrote (882)10/8/2003 12:16:55 PM
From: Icebrg  Read Replies (1) | Respond to of 3557
 
What struck me as strange was that the participants on 25 mg generally seen seemed to be doing better than those on 50 mg. And that the latter on some of the endpoints had results that were worse than the placebos.

This seems to indicate that their is great variability in the "responses" and indirectly also that maybe the results from the 100 mg group were more due to a fluke than to the drug. More of a "straight-line" dose response would have been more convincing and indicative of a trend.

Erik



To: Biomaven who wrote (882)10/8/2003 1:53:57 PM
From: nigel bates  Read Replies (1) | Respond to of 3557
 
They made the point in the CC that they had been constrained by fiscal concerns and drug supply concerns from running a decent-sized trial. Those constraints are now in the past...

Doesn't that argue for another PII ? Bottom line is a big delay, or a riskier PIII.