Replies to post #786313 on NorthWest Biotherapeutics Inc (NWBO)

[hankmanhub]

The key change is that once NWBO acquired Advent, the sponsor and the manufacturer became the same entity. Under SI 2025/87, that alignment allows Eden validation to be folded into the live MAA rather than pushed out as a Type II variation.

Without the acquisition, MHRA would almost certainly have required a sequential approval path: first the manual process, then a 60 to 90 day variation cycle to add Eden. By owning Advent, NWBO avoided that two step process. The MAA can now be reviewed as a single dossier with Eden embedded, one decision rather than two.

the obvious problem with this is that the Advent sale has not yet closed! Are you suggesting that they wait for the close of the Advent sale in order to qualify and not need a Type II variation??
Furthermore, they stated that the Advent close would not happen until after the MAA approval! Gets kind of circular very fast!