It seems to me, reading the article, that the drug company and the FDA had agreed on how a trial should go and the company hasn't done it yet.
Read it again.
Reuters reports the FDA wants to see data from a repeat-dose study involving Neffy and a rival injected product before a potential approval rather than after, as the two sides had earlier agreed upon.
The FDA agreed to the trial as it was done and has now changed it's mind after a rival to the product objected. The FDA changing it's mind based on the data is one thing. Changing it's mind at the behest of a competing company is disgusting.
EpiPen-maker Viatris had petitioned the FDA to require that ARS conduct additional trials "that closely mimic real-world conditions