NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

As far as the other RAs, all they have said is that the changed endpoint is safe and ethical. The acceptance of the IND protocol change in no way says they agree it is suitable for approval.

Sorry EX, you are wrong.
Here is my correspondence with the PEI. (Dec.2021)

My question:

"If a change in endpoints is entered in the German version of the European Union Clinical Trials Register, may I assume that the PEI has accepted the protocol change as suitable for approval?"

Reply from PEI:

Dear XXXXX

Generally spoken your assumption should be right. For a definitive answer we would need the EudraCT numbers to be able to cross check.

Kind regards
H. Krafft

.....................................................
Dr. H. Krafft
Referatsleiter Klinische Prüfungen
Head, Section Clinical Trials
Paul-Ehrlich Institut
Paul-Ehrlich-Str. 51-59
D-63225 LANGEN

My reply:

Dear H.Krafft,

Thank you for the reply. Much appreciated!

Here is the EudraCT number: 2011-001977-13 (European Union Clinical Trials Register).

https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-001977-13/DE

Is my assumpion about the study above still correct?

Best,

XXXXX

Reply

Dear XXXXX

For the mentioned Clinical trial (2011-001977-13) recent changes of the protocol/IB were subjected to substantial amendment procedures including explicit approval and rejection parts.
Due to our national law in the assessment of substantial amendment, grounds for non-acceptance could not be raised in Germany. So any substantial amendment applicaction is decided either positive, negative or negative on single parts. The result of the assessment can be found and reflecting the changes/ adaptions in the EU register after the entering the sponsor information into EudraCT by the national Competent Authorities. Errors in this process are possible. If you have any issue with the endpoint of this clinical trial, we would ask you to contact primarily the sponsor of the clinical trial. In the meantime we are open for any constructive suggestions/ criticisms.

Kind regards
H. Krafft