NorthWest Biotherapeutics Inc (NWBO)

[john1045]

1000. The method of PEI coordinates - Voluntary Harmonisation Procedure (VHP) clinical trials.

My comment: This 60 days approval for clinical trial is a good sign for Direct/Ketruda Phase II trial for colorectal cancer beginning enrollment soon, IMHO.

http://www.pei.de/DE/infos/presse/pressemitteilungen/2016/19-1000-vhp-verfahren-vom-pei-koordiniert-freiwilliges-harmonisierungsverfahren-klinischer-pruefungen.html

The method was of the 'Clinical Trials Facilitation Group' (CTFG), a working group of the HMA ( 'Heads of Medicines Agencies'), developed under the leadership of experts of the PEI. The period of the authorities has been reduced to approving a multinational clinical trial in all participating EU states usually 60 days This harmonization. Meanwhile, about 20 percent of all applications are filed on clinical trials to be carried out in several European countries over the VHP procedure.

"I am pleased that the voluntary harmonization process is now so well received by applicants worldwide and thus the time could be shortened to the approval of such multinational studies," says Dr. Hartmut Krafft, Head of Unit 'Clinical trials' of PEI.

"The VHP process was the model for the new regulations for clinical trials in the future valid procedure for authorizing the multinational European clinical trials in Europe. The PEI is proud to have contributed to the smooth coordination VHP to this success," adds, Klaus Cichutek, President of the PEI and head of the HMA Management group.