I beg to differ on what is the most important event on the timeline.
Obviously FDA approval is the end game and without it you go nowhere (in the USA) however the most important event was statistically significant findings of drug efficacy in the pivot phase III trial. Confirmation that the drug actually works.
Now it’s ticking the boxes to make sure it gets commercialised and gets to the people in desperate need of it. They’re going to have to come up with a significant reason to deny these patients a treatment in an area without a current treatment.
No one here can really come up with one
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