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. That's not an FDA problem, the company just has to do what it allegedly agreed to do prior to approval.

"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."

What I found interesting is that the article states that allegedly only "85% of people with severe allergies would be willing to carry a Neffy-like nasal product with them daily, while only 55% were willing to keep an injectable pen on them."

What's with the 15% and 45% that won't carry anything? Death wish? I doubt it, but it seems odd that one wouldn't carry a life saving device if a peanut could kill you.