Heron Therapeutics (NASDAQ:HRTX) has resubmitted
its NDA to the FDA for HTX-011, an investigational agent for the
management of postoperative pain. The Company anticipates a 6-month
review by the FDA.
The NDA was resubmitted based on the outcome and
final minutes of a Type A meeting with the FDA, which was conducted to
obtain clarity on the Complete Response Letter (CRL) issued in April
2019.
The FDA had previously rejected HRTX’s application for HTX-011 in April 2019.
Previously: FDA rejects Heron’s application for pain med HTX-011; shares down 1% premarket (May 1)
https://seekingalpha.com/news/3502845-heron-resubmits-nda-pain-med-htxminus-011
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