We shouldn’t forget that the primary outcome of interest in this trial is to evaluate safety. It’s good that they are also collecting information regarding efficacy and accuracy, but this trial is not set up for this specifically. So while they will get some good early indication of the likelihood of future success, I wouldn’t infer too much from this trial. Establishing safety, of course, is still a major milestone and will allow them to push ahead with a more robust trial.
I too am skeptical that they’ll be able to start trials within the next 5 months, but would love to be proved wrong!
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