Replies to post #39737 on NorthWest Biotherapeutics Inc (NWBO)

[Dan88]

In short, if there were ever a safety issue in the current P3 L trial, the FDA would have placed a hold on the trial, and the company would have to stop not only new screening of patients, but also treating any existing patients in the trial.

In the meantime, the sponsor will investigate what is the cause of the safety issue. If the investigation concludes the safety issue has nothing to do with DCVax-L vaccine, the results will submit to FDA. If FDA agrees, the trial may be resumed; on the other hand, if the investigation concludes the safety issue does have something to do with the vaccine, the trial may be over for ever!

I hope I will never need to reply to you for the same reason.

[Pyrrhonian]

Yep, and guess what Dan, that might happen here. The process is underway, and the end might just be a clinical hold. Which is what I told you the last time you posted that.

I think regulators will agree the therapy is safe enough to continue the trial, but there is risk they won't.

They determined (as Maverick pointed out) that KTE-C19 was safe enough to continue enrolling, but they paused after that death and submitted data to regulators.

This is common practice guys.

You also said:

In short, if there were ever a safety issue in the current P3 L trial, the FDA would have placed a hold on the trial, and the company would have to stop not only new screening of patients, but also treating any existing patients in the trial. -Dan

NO, they would NOT. That would ruin data! That only happens once a clinical hold is placed. In the meantime they ONLY cease screening new patients, submit data to regulators, and await a decision. Then they either resume enrolling or a clincal hold is placed and everyone stops therapy and the trial is scrapped.