NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

Only one RA, the FDA, has a rule that they must provide a non-bonding opinion on the SAP.

The FDA may or may nor have accepted the protocol changes as being safe and ethical,

The PEI and MHRA have accepted a protocol change as being safe and ethical. That is the only known fact. It says nothing about their opinion on the change being suitable for approval.

That NWBO will not simply come clean and tell the full story is telling, They use the social media army to pump garbage,

Exwannabe,

That is your opinion. Why not ask PEI?

My correspondence with PEI.:Q

If a change in endpoints has been introduced in the German version of the European Union's Registry of Clinical Trials, may I assume that the PEI has accepted the protocol change as suitable for approval?

Reply 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.

My reply:

Dear XXXXX.

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?

Reply PEI:

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.

And:

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
XXXXXX

IMO, it's obvious that the new endpoints are suitable for approval by the EMA.

For starters, here is an interesting read about European guidance:

Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial (CT-1)
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52010XC0330(01)

3.4.1. Amendments as regards the clinical trials protocol

119. With regard to the protocol, the following is a non-exhaustive list of amendments that are typically ‘substantial’:

(a)change of main objective of the clinical trial;
(b)change of primary or secondary endpoint which is likely to have a significant impact on the safety or scientific value of the clinical trial;

If the national competent authority states that it raises no grounds for non-acceptance, the sponsor can implement the changes, even if fewer than 35 days have elapsed since the filing of the substantial amendment.