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Re: DewDiligence post# 62299

Friday, 05/09/2008 12:11:54 AM

Friday, May 09, 2008 12:11:54 AM

Post# of 257253
>>HGSI is “still talking” with NVS about starting a q4w Albuferon study, according to today’s CC. Doesn’t sound as though this is a high priority.<<

As soon as the 1200 mcg q2w arm of the Phase 3 trial was stopped due to AEs, q4w dosing went out the window IMO. Because previous studies showed that in order to keep the trough from being so low as to allow an HCV rebound, at least 1800 mcg q4w is needed.

This also follows from common sense. 1800 mcg q4w is the same amount of drug as 900 mcg q2w, and less than that is clearly too low a dose.

If they can't dose at 1200 mcg, how can they dose at 1800 mcg?? One would expect that the 1800 mcg C_max would generate a lot more pulminary problems than 1200 mcg, regardless of the dosing interval.

So the fact that HGS continued to talk about q4w dosing after the pulmonary issue hit confused me.

Maybe eventually the talk will die down and it will be quiet ...

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