Replies to post #417046 on NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

With regards to the 'Specials' license
Is there a limit on the number of patients that can be treated under compassionate use or is it unlimited

abc1212,

IMO, it is not limited.
I believe a “capacity plan” should be in place.

In the UK ATMPs may be manufactured under a UK ‘Specials’.
Here, a bona fide, unsolicited request from the patient’s surgeon, in the form of a prescription, is required to commence the manufacturing process. The legal responsibility for use of the ATMP in this case rests with the surgeon.

ATMPs manufactured as ‘Specials’ must meet the expectation of 2003/94/EC [1] and Guidance Note 14 [2] and may be released by the Quality Controller (QC) of the manufacturing facility as opposed to the Qualified Person (QP).

[1] COMMISSION DIRECTIVE 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use. 222-226 (2003)

[2] MHRA Guidance Note 14: The supply of unlicensed medicinal products ("specials"). (2014).
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/373505/The_supply_of_unlicensed_medicinal_products__specials_.pdf