you are dreaming, none of that was part of our application. For that reason, it will not be part of the decision. period. if they filed for a variation to expand the application, it would require a disclosur
Though I basically agree, if NWBO wants to change the MAA it is not a "variation".
A variation is a change to an approved MA That language is very clear.
A change to an in-process MAA continues the process but allows the MHRA to restart he clock.