NorthWest Biotherapeutics Inc (NWBO)

[H2R]

PIM PR from way back when:

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

The EAMS is an important new initiative in the UK, launched by the Medicines and Healthcare Products Regulatory Agency (MHRA, the FDA of the UK), to lead the way in accelerating patients’ access to innovative new medicines for serious diseases. Information about the EAMS program can be found on the MHRA website at: http://www.mhra.gov.uk/Howweregulate/Innovation/EarlyaccesstomedicinesschemeEAMS/index.htm

The first step under the EAMS is MHRA’s scientific evaluation of whether a product candidate meets three criteria for a PIM designation: (i) the product is for a serious disease or condition with high unmet medical need; (ii) the product is likely to offer a major advantage over treatments available today; and (iii) the potential adverse effects of the product are outweighed by the potential benefits.

NW Bio’s DCVax-L has now become the first product to earn this PIM certification. There is no expiration on the PIM certification.

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.

Same question: Is PIM still in play?

Best of luck to Patients, NWBO, and Longs!