$HRTX The CRL indicated the agency required more non-clinical information, but did not cite any clinical safety, efficacy or CMC issues. The company indicates that four non-clinical issues were noted, none of which were related to toxicity. Three were linked to confirming exposure of excipients in preclinical reproductive toxicology studies. The fourth was related to changing the manufacturing release specification of the allowable level of an impurity based on animal toxicology coverage. Heron does not think any of the issues will be significant barriers to approval and has requested a Type A meeting with the FDA.
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