General Forum, page-972

Hi @Hercepin if the additional information request the company referred to was part of the interactive review then it makes no sense that the company is saying approval around mid year as the guidelines state no longer than a month. See the part of the FDA page immediately below what you included above re. the Additional Information (AI) Request stage. They obviously tried to correct this in the half yearly by changing the wording from 'kicked off THE interactive review process' to 'AN interactive process commenced'.
Good luck everyone - I won't be sticking around posting negative comments - I know how annoying it can be