NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

For a MAA/BLA, with a cell product, the manufacturing part is the most crucial if you know your data already shows survival. The PIP in a case like this also was and is a crucial part and not just a checkmark. For those claiming the trial is problematic, the approval of a similar trial, under the PIP, going forward, is a very positive indicator of the regulators likely view of the current trial. Of course they will kick the tires, that is their job.

Under the accelerated UK proves that feeds into Project ORBIS, with rolling approval possible, large chunks of the application having already been filed, there is no telling where they may already be in the process of getting approval. But we do know that the largest pieces of a BLA are these two pieces other than the consideration of results and we know that the MHRA and FDA have ways to expedite the rest of the process through programs that, by the way, Dr. Pazdur runs.