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.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”