Inspire Receives Second “Approvable” Letter For Diquafosol
This article was originally published in The Pink Sheet Daily
Executive Summary
Agency says trials failed to establish efficacy of the dry eye therapy.
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Inspire To Submit Additional Data For Dry Eye Treatment
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Inspire To Submit Additional Data For Dry Eye Treatment
Ongoing discussions between the company and FDA regarding diquafosol may take several months, Inspire says.
SEC Eyes Trading Around Inspire's Announcement Of Failed Diquafosol Study
A drop in the firm's stock on the morning that unsuccessful Phase III trial results for diquafosol tetrasodium were announced prompts a formal investigation by the Securities & Exchange Commission.