Replies to post #569347 on NorthWest Biotherapeutics Inc (NWBO)

[hoffmann6383]

NWBO trial clearly violated the guidance by implementing an ECA after the trial was virtually complete.

Except it wasn't after. It was before. Your misreading of the trial number as the trial date still continues. I'll keep pointing out this mistake as long as this bullshit narrative is put forth.

Have a good one Gro!

[SkyLimit2022]

HyGro, thanks for the reply.

Professor Ashkan is a careful and precise brain surgeon—listen to his words.

Skip to timestamp 13:00 of the ASCO video to hear about the ECA and the SAP.

Dr. Ashkan was the chief investigator of the murcidencel trial for patients in Europe. At King’s College in London, Ashkan is the lead clinician for neuro-oncology and the chair of the King’s Neurosciences Clinical Trial Unit. He is a world-renowned cancer trial expert. A few years ago, Professor Ashkan was named the UK Clinician of the Year by The Brain Tumour Charity. Additionally, Ashkan serves as an advisor to the U.K. government.



https://www.kcl.ac.uk/people/keyoumars-ashkan

https://brownneurosurgery.com/breakthrough-brain-cancer-vaccine/

https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847

[SkyLimit2022]

Thank you! I did not see this new draft guidance published this month. You’re right—everyone should read it in full context. Page 13 references SAP guidelines too, but the whole document is highly relevant and should be read in full.

https://www.fda.gov/media/164960/download



https://www.annalsofoncology.org/article/S0923-7534(22)00006-0/fulltext

https://brownneurosurgery.com/breakthrough-brain-cancer-vaccine/

https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847