Given AGN has just completed a Phase 2 trial with safety being the primary endpoint and having passed multiple safety reviews along the way, I'd be surprised if the FDA expects any other data ie further animal studies. Any CMC issues should've been dealt with prior to submission.
If they resubmit with the trial data and the data is positive, there's a good chance they'll grant BTD as well as IND. What's most disappointing though is the FDA, if a company follows guidance about what they need to submit and its unsatisfactory who's to blame? Telix didn't get over the line with their recent NDA/BLA submission even after following a drawn out guidance process. Drug companies dont want to provoke the ire of the FDA so they are usually respectful and deferential, for these companies to highlight the setbacks in spite of following guidance hints at the internal frustration of management.
AGN Price at posting:
68.5¢ Sentiment: Buy Disclosure: Held
A personalised tool to help users track selected stocks. Delivering real-time notifications on price updates, announcements, and performance stats on each to help make informed investment decisions.
(20min delay)