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Re: H2R post# 301429

Friday, 08/21/2020 6:02:23 PM

Friday, August 21, 2020 6:02:23 PM

Post# of 701435
Hi H2R. Yes the PIM designation is still valid. Unlike the Hospital Exmeption which expires after 5 years, the PIM designation does not expire. It’s likely why Les is under the impression (and has apparently told various investors) that Northwest Bio may be able to get an expedited approval there.


Promising Innovative Medicine (PIM) Designation - Step I of Early Access to Medicines Scheme (EAMS)

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/375327/PIM_designation_guidance.pdf


Do designation opinions expire?
No, the designation is a statement at one point in time, that the product shows promise in a particular patient setting and is suitable for future application to the EAMS scientific opinion step
.



More about EAMS timeline here:
https://www.gov.uk/guidance/apply-for-the-early-access-to-medicines-scheme-eams
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