NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

German Hospital Exemption does not appear to have been withdrawn.

https://portal.dimdi.de/websearch/servlet/Gate;jsessionid=BC27FBE16694B752D9E32A024DA014BB?accessid=pharmnet_par_freeinfo&query=enr=2613044

Applicant: Northwest Biotherapeutics GmbH
Marketable: yes
Approval / Reg No. (AMG76): PEI.A.11674.01.1
composition

Which just means the HE is still valid, not that it's approved. However, if the predicate conditions end up not being met for HE, it has to be withdrawn. Any indications that that happened that I'm unaware of?

I haven't seen anything and this site seems to be the definitive source. But please let me know otherwise.

https://www.pei.de/EN/medicinal-products/advanced-therapy-medicinal-products-atmp/advanced-therapy-medicinal-products-atmp-node.html

The table below lists ATMP which have a valid centralised marketing authorisation for the EU and those which have been exempted from the centralised marketing authorisation and have a national authorisation pursuant to the special provisions of Section 4b AMG.

Products that have been granted a centralised marketing authorisation can be recognised by their marketing authorisation number which begins with the characters EU/…. If the European Medicines Agency (EMA) provides further information in the form of a European Public Assessment Report (EPAR), you will find the corresponding link in the table.

ATMP which have been granted a national authorisation pursuant to Section4b AMG can be recognised by their authorisation number which begins with the characters PEI.A.xxxxx.xx.x.

The table below does not provide any information as to whether the products are available on the market. The information provided here is supplied without liability for errors or omissions. For information which is legally binding, please refer to the relevant marketing authorisation certificate or national authorisation certification. Official publications of the Paul-Ehrlich-Institut appear in the Bundesanzeiger (Federal Gazette).

DCVax-L 1,25 x 106 lebende dendritische Zellen/Kryoröhrchen

Autologe dendritische Zellen, die mit Tumorlysatantigen des Patienten inkubiert wurden (sog. Antigen-präsentierende Zellen)

Northwest Biotherapeutics GmbH PEI.A.11674.01.1 21.02.2014
PharmNet https://portal.dimdi.de/websearch/servlet/Gate;jsessionid=0D8004CCC70FDA101BF316697EDEDC87?accessid=pharmnet_par_freeinfo&query=enr=2613044

Why would it still be listed as current if the German trial was found to have been confounded years ago?