NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

Hoffman or Lykiri, Can you find anything in the MHRA universe that suggests rolling reviews, in some cases, may not require a CHM consult 90 days out from submission? They do meet with CHM in presubmission meetings, is it possible, that since presubmission really means pre-final submission, the consult is mostly achieved at the presubmission hearing, and any post submission consult might be done much more quickly/early in some cases?

Reply from MHRA:

Dear XXXXX,

A rolling review application allows for pre-assessment of individual eCTD modules. During pre-assessment, CHM may be consulted. The final assessment phase will include at least one consultation with the CHM. However, because pre-assessment has occurred, the final assessment phase may be more streamlined compared to a conventional MA procedure.

Prior to any rolling review application, a pre-submission meeting should be requested.

Kind regards,

Annabelle

MHRA Customer Experience Centre