Ækvivalensen mellem test - og referenceprodukterne er dog stadig ikke fuldt ud påvist, selv om dette kan ske ved at indsende en analyse af dataene fra den igangværende undersøgelse 2007- 76- DOS- 6, og CHMP fandt frem til to uafklarede spørgsmål, som ansøgeren skulle redegøre for under en mundtlig redegørelse:
However, equivalence between the test and reference products has still not been fully demonstrated although this may be addressed by submitting an analysis of the data from the ongoing study 2007-76-DOS-6, the CHMP addressed two outstanding issues to be discussed by the Applicant during an oral explanation: