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exwannabe

11/09/22 12:11 PM

#529543 RE: vator #529498

Not a trial hold. It was a screening hold. If people were already screened they were allowed to enter treatment.


It still is a clinical hold issued by the FDA.

And it was exactly the same as we saw with CVM when they received a futility rec.
. Enrollment stopped but enrolled patients continued on trial
. CVM eventually decided they had enough patients and closed enrollment. Upon that the FDA lifted the hold.

There are so many things NWBO could explain, yet they never do. They leave that up to the SMA.
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HyGro

11/09/22 12:35 PM

#529562 RE: vator #529498

FDA partial trial hold. That's what FDA calls it and what NWBO calls it. Yes, it stopped NWBO from recruiting, screening and admitting more patients to the trial. NWBO mysteriously never identified the reason for the partial hold. But is has to be a significant reason for the FDA to actually place a partial trial hold.