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Replies to #81125 on Biotech Values
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dewophile

07/20/09 8:03 PM

#81126 RE: dewophile #81125

idix

correction - valpicitabine 800 did about .65 on day 3, so in fact the higher doses of 184 were slightly more effective at day 3. the trough of the VL reduction curve was around day 10, so this difference very well may be much greater at time points further out
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DewDiligence

07/20/09 8:11 PM

#81129 RE: dewophile #81125

IDIX:

if efficacy can't be ascertained [in a 3-day monotherapy study] then how does this serve as a proof of concept?

The study was a proof of concept insofar as it proved that the prodrug is converted in vivo to the monophosphate nucleotide and that the monophosphate nucleotide reaches the infected hepatocytes.

In terms of actual efficacy, the 3-day monotherapy study does not really prove anything. IDIX uses of the phrase “proof of concept” to describe the study because this is the specific language that triggers NVS’ opt-in rights in the agreement between the companies.