If survival is the basis for approval | NWBO Message Board Posts

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Msg  13313 of 13323  at  7/10/2019 8:54:35 PM  by

GaryM


If survival is the basis for approval

It should be easy to understand why the longer the trial lasts, the greater the survival data should be. Ending the trial 36 months after the latest person entered the trial would seem to be reasonably impressive, but 48 months later is certainly more impressive, that's roughly where things would stand if they present the data at SNO.

If the data didn't warrant approval, I don't believe that Dr. Liau would have presented what she recently did. We know a lot of people remain alive, statistically that number would be much lower with the SOC treatment alone. Survival certainly seems like it will be the basis for gaining approval and should be very impressive, even if the FDA were to say, run an additional trial. I believe we'd gain approval elsewhere, and once again the FDA would be seen as needing to change. I believe they'll gain approval, but nothing is certain when it comes to the FDA. Sadly many drugs are delayed for years and cost the drug makers hundreds of millions in additional trial costs to satisfy the FDA.

Gary


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