Replies to post #435380 on NorthWest Biotherapeutics Inc (NWBO)

[highwayman4life]

A trial hold (of any sort) is placed by regulators. They are based on safety/ethics

Ironically a clinical trial can be placed on a "partial hold" during an SPA (Special Protocol Assessment" where a sponsor is in directy communication with the FDA. Not an uncommon event at all. If the sponsor and FDA come to agreement on SPA changes to the trial...the hold is lifted.

[biosectinvestor]

The German RA becomes knowledgeable about the entire trial, not just the patients treated in Germany, once they become a relevant RA on a trial. Germany has a very difficult history with unethical human experimentation that they take quite seriously, perhaps more seriously than any other jurisdiction in the developed world.

[highwayman4life]

Incorrect statement yet again Ex:

A trial hold (of any sort) is placed by regulators. They are based on safety/ethics.

It seems as though you are wrong again Ex...No safety/ethics issues cited in this recent example and ironically looks very similar to NWBO. Partial Halt on new patient recruitment and then the halt is lifted. Absolutely zero to due with safety/ethics.

The U.S. Food and Drug Administration (FDA) placed Princeton, NJ-based Advaxis’ Phase III clinical trial of axalimogene filolisbac (AXAL) in advanced cervical cancer on partial clinical hold.
No safety issues were cited. Instead, it appears related to the company’s proposal to modify the trial’s analysis plan and various chemistry, manufacturing and controls (CMC) issues. The trial is an ongoing randomized, double-blinded, placebo-controlled, pivotal trial of AXAL in high-risk, locally advanced cervical cancer (AIM2CERV).
The partial hold means no new patients can enroll in the trial until the hold is lifted.
https://www.biospace.com/article/fda-places-advaxis-cervical-cancer-trial-on-clinical-hold/