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flipper44

02/07/18 2:20 PM

#157239 RE: Mike238191 #157237

They can (aka: I agree with you). There are fellow longs I disagree with vehemently on the topic.

Nevertheless, let's say NWBO ultimately obtains approval. If you look at the probable timing of submission to UK's NICE (Summer 2018)(starting just 10 short days after ASCO), it looks like NWBO wants to "get it right the first time" through. It's the Billy Joel theory on first time pricing impressions. It's also the first time impression theory on the market acceptance impact. Early patient access would be the victim -- sadly. Would this be made up for later in overall patient access to reimbursable therapy? I guess that might be the hypothetical tradeoff they are "weighing." The reason they went past Christmas 2017 and are instead going into spring 2018?

Bored Lawyer

02/07/18 2:21 PM

#157240 RE: Mike238191 #157237

The same question is nagging at me as well. I know there has been some discussion in the past regarding the treatment of patients who are still alive when the trial is unblinded (right censoring of data points, etc.), but either I didn't pay close enough attention or the discussion was over my head at the time.

Can anyone provide a clear answer to this question for us laypersons?

A clear answer to this question might resolve confusion for a lot of folks who wonder what's the incentive to stay blinded.

Thanks in advance.

Why can’t they continue to measure the long tail after the data is unblinded? I don’t see why they can’t keep tabs on these 100 or so people to see if they are still alive. This makes no sense to me

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iclight

02/07/18 2:53 PM

#157246 RE: Mike238191 #157237

Unblinding would show the failed primary endpoint.