Everyone keeps saying that the drug failed, when in fact the trial failed. The drug failed to demonstrate efficacy for the end points selected for the trial which is different to the drug having no beneficial impact on a particular disease or quality of life. The postmortem of the results will provide some more insights into what went wrong and if there is anything to learn and go forward with. A fresh look at the results from different perspectives may identify why there was requests to provide ongoing access to the drug outside the trial. There might just be some method of action that can be found and qualified from the results. There have been a number of drugs that have missed trial end points and still been approved by the FDA. One such case was where there was a demonstrated improvement in a sub pollution of the trial.
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