NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

I think the difference in the UK and Germany clinical trial information is simply due to the fact that NWBio knows that they will pursue DCVax-L approval in the UK first.

NWBio has fast track approval access for DCVax-L in the UK because of its Promising Innovative Medicine (PIM) designation. As a result, NWBio and the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK needed to move quickly to update the UK (GB) clinical trial register with the new SAP and the revised endpoints.

The PIM process is a 3 step process. NWBio has completed the first step. NWBio is in the process of completing Step 2. Step 2 will be completed when NWBio submits the DCVax-L clinical trial results, including TLD, to MHRA and show that they have the manufacturing capacity to produce DCVax-L in accordance with GMP guidelines (Advent).

MHRA aims to deliver the Scientific Opinion within 90 days after a party submits an application for Step 2 of the EAMS process.

https://nwbio.com/nw-bios-cancer-vaccine-is-the-first-drug-to-be-designated-by-uk-authorities-as-a-promising-innovative-medicine-pim/

The other 3 regulatory agencies (Germany, US and Canada) will follow suit with updates soon. But, now the focus is on the UK.