NorthWest Biotherapeutics Inc (NWBO)

[hankmanhub]

We generally cannot grant an MA based solely on the original process if the applicant no longer intends to use it.

The key is in the phrase "if the applicant no longer intends to use it." Our situation is that the applicant DOES intend to use it! So it qualifies. It is also true that the applicant is also working on future developments to mass produce the treatment which when ready will later be presented to the regulator. This in no way places the current application in any jeopardy. It does not state that an applicant may not work on future developments while awaiting approval on the current application. It merely states that a treatment already abandoned will not be approved. This is what is meant by:

We generally cannot grant an MA based solely on the original process if the applicant no longer intends to use it.
The MA must reflect the commercial manufacturing route.