If the company could get full approval from the FDA simply by designing and initiating a new trial and promising to run it in good faith, wouldn't any CEO jump on that opening?
I agree with you on this point. I believe the issue has to be resolved with the current data set from the trials and the extention trials.
you would think that since they have been following over 800 people for well over a year in the extention trial that would have enough safety data to answer the question.
If the extention data shows a safety issue than a new trial wouldn't accomplish anything accept confirm the problem.
Either way a new trial won't accomplish anything. It should either get approved with the current data or not.
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