June 29, 2020 / 1:04 PM / 7 days ago

BRIEF-Heron Therapeutics Receives CRL For HTX-011 For Management Of Postoperative Pain

June 29 (Reuters) - Heron Therapeutics Inc:

* HERON THERAPEUTICS RECEIVES COMPLETE RESPONSE LETTER FOR HTX-011 FOR THE MANAGEMENT OF POSTOPERATIVE PAIN

* HERON THERAPEUTICS INC - NO CLINICAL SAFETY OR EFFICACY ISSUES AND NO CHEMISTRY, MANUFACTURING AND CONTROLS (CMC) ISSUES IDENTIFIED

* HERON THERAPEUTICS INC - COMPLETE RESPONSE LETTER REQUESTS ADDITIONAL NON-CLINICAL INFORMATION

* HERON THERAPEUTICS INC - COMPLETE RESPONSE LETTER REQUESTS ADDITIONAL NON-CLINICAL INFORMATION

* HERON THERAPEUTICS INC - CRL STATED THAT FDA IS UNABLE TO APPROVE NDA IN ITS PRESENT FORM BASED ON NEED FOR ADDITIONAL NON-CLINICAL INFORMATION

* HERON THERAPEUTICS INC - FDA DID NOT IDENTIFY ANY CLINICAL SAFETY OR EFFICACY ISSUES OR CMC ISSUES

* HERON THERAPEUTICS INC - THERE ARE FOUR NON-CLINICAL ISSUES IN CRL, NONE OF WHICH RELATE TO ANY OBSERVED TOXICITY

* HERON THERAPEUTICS - THERE ARE FOUR NON-CLINICAL ISSUES IN CRL, NONE OF WHICH RELATE TO ANY OBSERVED TOXICITY

* HERON THERAPEUTICS INC - WILL REQUEST A TYPE A MEETING TO OBTAIN AGREEMENT WITH AGENCY ON RESPONSES AND RESUBMIT APPLICATION AS QUICKLY AS POSSIBLE Source text for Eikon: Further company coverage:

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