Saturday, December 30, 2017 8:45:03 AM
That is false. It has never been disclosed when the FDA hold was issued. We can safely assume it was about the start of Aug is all.
The hold was publicly discovered first in Germany because the German trial registry was properly updated while here in the US we allow the sponsors to update whenever they feel like.
The FDA hold was only publicly disclosed after it was obvious something was going on. Can not well keep it a secret when 100s involved at the sites have been informed the trial is on hold.
The reasonable relationship between the 2 is that the FDA issued a hold in the US. Then NWBO voluntarily issued the other holds before they where put on hold by the others acting on the FDA's information.
Just like with NASDAQ decision to quit before being kicked out. Some will assume that acting voluntarily somehow makes the situation less serious.
EDIT: On the reason to believe FDA came first:
If NWBO wanted the trial on hold, they could have put the entire trial on hold. So why did NWBO issue their voluntary hold only ex-US? Most likely because US was already on FDA hold. Also, why would the FDA suddenly see something forcing a hold at almost the exact same time as the ex-US hold?
Very convoluted logic to come up with a rational explanation of ex-US being prior to US. While the other direction is clear, once the FDA issued the hold it would make perfect sense for NWBO to hold the entire trial.
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