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Biotech / Medical : Ionis Pharmaceuticals (IONS)
IONS 72.14+3.8%12:34 PM EST

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To: SemiBull who wrote (3172)11/29/2001 10:35:35 AM
From: tuck  Read Replies (1) of 4676
 
SB,

Well, they're not saying a lot. They're using complete clinical remission as the primary endpoint, same as before. So far as I know, only the dose has changed, but I don't know what it is.

The only reference to dosing I've seen is here:

Message 14509638

2mg/kg wasn't enough to give every patient sufficient exposure to the drug. I'd have to dig way back to find MTD, etc. I wouldn't expect the new dose to be higher than 3mg/kg, but I know nada.

This stuff is supposed to be dealt with in PII. Wonder how the designs/analyses were sufficiently flawed to reduce the PIII to a "pilot study" (which I'll call a PIIc). Hope the the clinical developers responsible are elsewhere now. Haven't paid attention to see if other players in the Crohn's market have put this 18 month stumble to good use.

Cheers, Tuck
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