As i understand it:
Nanoenzalutamid doesn’t match the Cmax corridor of the originator product (fed and fasted), but the AUC is the same.
In simple terms, it can be expressed as follows: With the original drug, there is a temporary, steep rise of the active ingredient in the blood, whereas with Nanoenzalutamide, this increase is lower and more gradual. Over time, however, the overall absorption of the active ingredient is identical
That’s why they can’t go the generic route, because Nanoenzalutmid is not bioequivalent to Xtandi, which is required for the generic route.
So they want to go the hybrid way. Traditionally, additional human studies were necessary in order to proof that your product is safe and not inferior to the originator.
Nanoform wanted to replace these additional human studies with computer simulation data.
ICH M15 is a guidline which allows to replace the additional human studies with computer simulation data.
When Nanoform contacted EMA the first time, probably sometime in 2025 already, the content / draft of ICH M15 was already published, but not ratified yet. It was ratified end of January / begin of February 2026.
But according to this source the guidline just came into effect on 23rd July 2026 in the European Union.
So if Nanoform would consult EMA with the same data package again, they might get a positive response about the hybrid route now. Maybe it was just unlucky about the timing or Nanoform expected that the EMA would consider ICH M15 already before it officially came into effect.
But it’s just speculation, as the CEO said.
EDIT:
here the source i found