NorthWest Biotherapeutics Inc (NWBO)

[TheFollower]

In regards to Sawston & PIM for DCVax-L:
does anyone know if Sawston needs to be manufacturing before EAMS "Promising Innovative Medicine"(PIM) Step 2 can be completed?

..also, would the Interim Analysis for DCVax-L need to be complete before Step 2 of (PIM) can be determined?

Back in the Sept. 16, 2014 press release it was stated:

The second step under the EAMS is MHRA's determination of a Scientific Opinion about the product candidate's benefits and risks, based on available clinical data. A positive or negative Scientific Opinion will be judged by the same three criteria as for the PIM designation, as well as a fourth criterion: the Company's ability to manufacture the product to rigorous "GMP" (clinical grade) standards.

If the Scientific Opinion is positive, the product candidate may then be prescribed by physicians and provided to (and paid for by) patients before the product is formally licensed and while it is still in clinical development.

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

http://www.prnewswire.com/news-releases/nw-bios-cancer-vaccine-is-the-first-drug-to-be-designated-by-uk-authorities-as-a-promising-innovative-medicine-pim-275263351.html