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News Focus
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exwannabe

09/19/22 1:02 PM

#515036 RE: ccie1024 #515028

Not updating a website for endpoints was not unusual behavior. Prior to May 2022 the web page had not been updated since 2016. For almost 6 years it estimated the primary completion date to be in the past.

Updating a website was never a primary concern of the company until the information was used to successfully attack them. Combined with the unfortunate slide that focused too much attention to the PFS results, it allowed the naysayers to connect the dots.


No doubt NWBO has failed badly in their legal responsibilities in this area.

But as you bring up Primary Completion Date, why is it now in the future? This is the date when the dataset for the primary analysis is available. That is the data that is used both for BLA/MAA submissions and a paper.

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. .



Many trials continue to collect data well after the primary completion. That this trial continues to collect OS data does not mean the primary completion h6as not been reached.
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flipper44

09/19/22 1:06 PM

#515040 RE: ccie1024 #515028

I think you have it backwards in terms of what proactive modification would have achieved, but because they don’t mention why they waited, they always get the benefit of the doubt that there was a valid reason, at least for now.