NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

Instead of updating the status to. “Restarted”, why do these European clinical trial sites not change the status instead to “Trial Completed; awaiting Top Line Data”?
IMO the status “restarted” gives the false impression that the trial is ongoing again and starting to enroll or provide more treatments to patients. I would prefer to see that trial is done, and that all that remains is submitting TLD.

Evaluate,

European rules.

Communication from the Commission — 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)
2010/C 82/01

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52010XC0330(01)

3.10. Temporary halt of a trial

146. A temporary halt of a trial is a stoppage of the trial which is not envisaged in the approved protocol and where there is an intention to resume it.

147.
A temporary halt can be:
— a substantial amendment, or
— part of an urgent safety measure as referred to in Article 10(b) of Directive 2001/20/EC. In this case, the notification of the temporary halt of a trial should be made immediately and, at the latest, in accordance with the deadline set out in Article 10(c), second sentence, of Directive 2001/20/EC, within 15 days from when the trial is temporarily halted.

148. The reasons and scope, e.g. stopping recruitment or interrupting treatment of subjects already included, should be clearly explained in the notification (in case of substantial amendment, see Section 3.7) or in the ex post information (in case of urgent safety measures, see Section 3.9).

149. The restart of the trial should be treated as a substantial amendment providing evidence that it is safe to restart the trial.

150. If the sponsor decides not to recommence a temporarily halted trial he should notify the national competent authority of the Member States concerned within 15 days of his decision in accordance with Article 10(c), second sentence, of Directive 2001/20/EC (see Section 4.2).

4.2. Procedure for declaring the end of the trial

4.2.1. General rules

159. The sponsor has to make an end of trial declaration when the complete trial has ended in all Member States/third countries concerned. The end of the clinical trial is defined in the protocol (see Section 4.1).
160. This declaration has to be made to the national competent authority and the Ethics Committee of all Member States concerned within 90 days of the end of the clinical trial.
To this end, the form published in Volume 10 of EudraLex — The Rules Governing Medicinal Products in the European Union (54) should be used.

161. The notified Member States are responsible for entering this information into the EudraCT database.

Remember this:
FORM 10-K
For the fiscal year ended December 31, 2017

The trial was on partial clinical hold for a period of time in regard to screening of new patients for enrollment; however, the patients already in the trial continued to be treated in accordance with the trial protocol, without interruption. In December 2016, the Company announced that to date the regulators had not agreed to remove the partial hold, and the Company had determined that it would not enroll the last 17 of the planned 348 patients. Thereafter, in February 2017, the FDA lifted its partial hold. The Company had self-imposed a hold on screening in countries outside the US, this remains in place in agreement with the regulators, and the Company will not enroll the last 17 patients as announced in December 2016.

https://www.sec.gov/Archives/edgar/data/1072379/000114420418020971/tv491101_10k.htm