NorthWest Biotherapeutics Inc (NWBO)

[Chiugray]

Gary, Actually that's a good question. The NWBO press release did say they were going to go straight to Phase 2 with changes for number of tumors injected and injection frequency.
https://nwbio.com/nw-bio-announces-data-date-dcvax-direct-phase-trial/

I asked AI if these changes require going back to Phase 1?
"Not necessarily. According to FDA regulations and standard clinical practice, significant changes in a clinical trial’s protocol (such as injecting more lesions or changing dosing frequency/schedule) must be approved through a formal protocol amendment. Whether a study must revert all the way to Phase 1 depends on the nature of the change and available safety data...

If there is strong safety data from previous experience showing similar risks, and the changes can be adequately justified (with a risk assessment), often a protocol amendment is sufficient."