NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

Exwannabe,

Your quote:

“LP/NWBO hyped the PIMS designation. AF called BS. This board was citing PIMS as evidence of how good DCVax-L was,and calling AF an idiot for mocking it.

As time goes by, turns out NWBO never even follows up with the important work, getting the science reviewed. The PIMS designation was no more than a paperwork action. I wonder how many shares NWBO sold into that?
_______________________________________________________________________

Hmmm, strange statement for someone who follows this ihub board 24h/d.

We discussed this topic in the past few months! For clarity :first you have PIM (Promising Innovative Medicine) designation. At the end you have NICE Technology Appraisal.

See p.6 EAMS Schematic.

https://www.nice.org.uk/Media/Default/About/Who-we-are/Policies-and-procedures/eams-process-jan-16.pdf

“i. Promising Innovative Medicines (PIM) designation and NICE Topic Selection

– A PIM designation gives an early signal that, based on the evidence to date, the medicine may be a possible candidate for the Early Access to Medicines Scheme and thus has the potential to be of value in areas of unmet medical need. The MHRA operates the process resulting in a PIM designation.”

“vi. EAMS period and NICE TA or HST evaluation.

NICE anticipates that before the EAMS period starts, all EAMS products will already have been selected as topics for a NICE TA or HST evaluation.
In order to develop timely guidance, NICE starts the TA or HST evaluation during the EAMS period (before marketing authorisation), and the company prepares its submission during this period. Any data collected during the EAMS period may be included in the company submission.”

https://www.nwbio.com/first-uk-promising-innovative-medicine-designation-awarded/

"Linda Powers, CEO of Northwest Biotherapeutics Inc, said:

We are most grateful to the MHRA and Minister Freeman for spearheading this new Early Access to Medicines Scheme (EAMS). It strikes a very practical balance between clinical benefits and risks, through careful scientific evaluations, and will be of great help to doctors and patients in opening up new treatment options.

We are very excited to have DCVax-L receive the first designation under the EAMS, and believe that DCVax-L embodies the combination of innovation and beneficial balance of clinical benefits and risks that the EAMS is designed to accelerate."