No, the guidance is just guidance and they consider all the facts. It’s quite clear in the guidance you linked to that what I said is the case and in fact the external control group guidance and further articles speak to the challenges of this exact trial.
Orphan diseases that are fatal, with treatments that efficacious and safe, that extend OS are likely to be looked at very specifically as well, with an eye toward ensuring the interests of patients are taken into account.
But you have been misquoting the company and selectively providing info to make only one case which is not consistent with reality and is in fact a false light narrative.
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