NorthWest Biotherapeutics Inc (NWBO)

[FeMike]

Slave1

Can you comment on why you said:

The NICE process cannot formally begin, meaning the sponsor cannot submit an evidence package, until the MHRA has finalized the SmPC (Summary of Product Characteristics).

And one hour later, said:

NICE Requires a Draft SmPC, Not a Finalized One
NICE’s submission process does not require a finalized Summary of Product Characteristics (SmPC).
Nowhere does the document say a final SmPC is necessary before submission.

Please understand, to the layman, the two claims do seem contradictory.

In one quote, you say that the MHRA is required to finalize the SmPC prior to the sponsor submitting an evidence package.
In the next quote, you say that the MHRA is not required to finalize the SmPC prior to the sponsor submitting an evidence package.

Thanks in advance for the clarification.

Glass Joe