NorthWest Biotherapeutics Inc (NWBO)

[sentiment_stocks]

The safety and efficacy had not been evaluated and NWBO knew it:

Quote:
In the BAG's processing and decision on the Company's "Autorisation application and data, Swissmedic ("Institut Suisse des Agents Therapeutiques ) only conducted the inspection and did not conduct any evaluation of the safety or efficacy of DCVax®-Brain.

The safety and efficiy had not yet been evaluated, as that is not needed for an import/export license.

Why do you focus on safety or efficacy when it wasn't initially needed? BAG were the ones who had granted the Swiss Authorization for use to NWBO and didn't require it. The authorization was transferred from BAG to Swiss Medic about 3 months later, and eventually, they decided to require it.

What was required from BAG was clean room validation.

This authorization is conditional upon certain implementation commitments that NWBT will have to fulfill before the import/export activity can proceed (e.g., finalizing its pending arrangements for a clean-room suite for processing of patients' immune cells.) The process of this fulfillment is under way.

It was then Swiss Medic, to whom the authorization was transferred to, who later decided safety and efficacy needed to be proven.

And I go over that in this post, which perhaps you missed?

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=142325584