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Re: DewDiligence post# 73656

Thursday, 02/26/2009 9:21:44 AM

Thursday, February 26, 2009 9:21:44 AM

Post# of 257253
Re: R7128 phase-2 trial design


I’m not sure whether having three trials arms with the 90mcg “half” Pegasys dose (including one arm that tests 90mcg Pegasys with the extra-high 1500mg BID dose of R7128) should be viewed as bullish or bearish for R7128.



I view it as bullish but I am a little biased (ITMN) smile. First they are testing higher doses of R7128 (so one would think they aren't concerned about the safety from the added 500mg). Second one would think this could give them an edge in tolerability (if successful). Third, I wonder if PEG pricing will be discounted and the premium placed on the newer compounds.

The puzzler is I thought I heard Pharmasset say the 1000mg is the optimal dose with little/no efficacy beyond?

It'll be interesting to see what Roche does with 191 if they follow a similar design or find yet a new twist to try smile.

Dew, do you recall SGP or VRTX (or anyone else) trying lower doses in their studies?


Isn’t it odd that the actual design differs in so many respects from the intended design described in the 1/12/09 PR?


I wonder if that was a change or they wanted to hold off letting competitors know what they were doing. I seem to recall InterMune/Roche doing something similar with INFORM-1 until genisi pointed out the clinicaltrials.gov listing.

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