The company did not say why the agency was delaying a decision for the non-opioid pain medication although it said FDA officials were indicating they could complete their work in less time.
Heron also said the FDA has completed its re-inspection of the company's contract manufacturer and is now recommending approval of the site. The agency previously had raised questions about chemistry, manufacturing and controls at the facility in an April 2019 complete response letter.
Price: 20.65, Change: -1.01, Percent Change: -4.66
|Consensus for Zumiez Q2 Earnings Raised but Full Yea...|
|Williams Sonoma's Q2, 2021, 2022 Full Year Earnings ...|
|Analysts' Ratchet Up 2020, 2021 Consensus Estimates ...|
|Q1, 2021, 2022 Earnings Estimates for Advanced Drain...|
|Q2 Projection for Westlake Chemical Increased but 20...|