FDA Process ConcernsThe issue with the FDA process is expected to continue being an overhang, putting pressure on PHAT shares.
Patent UncertaintyThere is elevated uncertainty due to the company's unsuccessful efforts to extend exclusivity to 2032, resulting in a forecasted loss of exclusivity in 2030.
Seasonal TrendsFirst quarter trends are softer than expected, affected by typical seasonality factors such as holiday impact, a shortened month, and deductible resets.