{"id":25753,"date":"2022-05-28T13:35:01","date_gmt":"2022-05-28T13:35:01","guid":{"rendered":"https:\/\/celonpharma.com\/?p=25753"},"modified":"2022-05-28T13:35:01","modified_gmt":"2022-05-28T13:35:01","slug":"current-report-no-11-2022-positive-outcome-of-fdas-assessment-process-of-the-ind-application-concerning-the-commencement-of-a-clinical-trial-for-falkieri-celons-esketamine-dpi","status":"publish","type":"post","link":"https:\/\/celon.group\/en\/2022\/05\/28\/current-report-no-11-2022-positive-outcome-of-fdas-assessment-process-of-the-ind-application-concerning-the-commencement-of-a-clinical-trial-for-falkieri-celons-esketamine-dpi\/","title":{"rendered":"Current report No. 11\/2022 \u2013 Positive outcome of FDA&#8217;s assessment process of the IND application concerning the commencement of a clinical trial for Falkieri (Celon&#8217;s esketamine DPI)"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">Current report No. 11\/2022<br>Date prepared: 2022-23-05, at 4:14 pm<br>Abbreviated name of the issuer: CELON PHARMA S.A.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">In connection with current report No. 9\/2022 of 20 April 2022 on Celon Pharma S.A. (the \u201cCompany\u201d) submitting an application to the Food and Drug Administration (FDA), the Management Board of the Company informs that today it has received information from the American regulatory authority that the Company may commence clinical trials of Falkieri (Celon\u2019s esketamine DPI), a drug developed as a therapy for treatment-resistant bipolar depression under the approved Investigational New Drug (IND) application in the US.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Submission of the application and receiving the above-mentioned consent to commence the clinical trial was, among others, the result of preparation and submission of a qualitative portfolio including, among others, outcomes of manufactured and released batches of Falkieri, (Celon\u2019s esketamine DPI), which meet the FDA\u2019s quality criteria.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">More information about the progress in regard of this project in the US will be communicated in subsequent announcements.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Current report No. 11\/2022Date prepared: 2022-23-05, at 4:14 pmAbbreviated name of the issuer: CELON PHARMA S.A. In connection with current report No. 9\/2022 of 20 April 2022 on Celon Pharma S.A. (the \u201cCompany\u201d) submitting an application to the Food and Drug Administration (FDA), the Management Board of the Company informs that today it has received<a class=\"excerpt-read-more float-right\" href=\"https:\/\/celon.group\/en\/2022\/05\/28\/current-report-no-11-2022-positive-outcome-of-fdas-assessment-process-of-the-ind-application-concerning-the-commencement-of-a-clinical-trial-for-falkieri-celons-esketamine-dpi\/\" title=\"ReadCurrent report No. 11\/2022 \u2013 Positive outcome of FDA&#8217;s assessment process of the IND application concerning the commencement of a clinical trial for Falkieri (Celon&#8217;s esketamine DPI)\">Read more &raquo;<\/a><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[25],"tags":[],"class_list":["post-25753","post","type-post","status-publish","format-standard","hentry","category-current-report"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.8.1 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Current report No. 11\/2022 \u2013 Positive outcome of FDA&#039;s assessment process of the IND application concerning the commencement of a clinical trial for Falkieri (Celon&#039;s esketamine DPI) - CelonGROUP<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/celon.group\/en\/2022\/05\/28\/current-report-no-11-2022-positive-outcome-of-fdas-assessment-process-of-the-ind-application-concerning-the-commencement-of-a-clinical-trial-for-falkieri-celons-esketamine-dpi\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Current report No. 11\/2022 \u2013 Positive outcome of FDA&#039;s assessment process of the IND application concerning the commencement of a clinical trial for Falkieri (Celon&#039;s esketamine DPI) - CelonGROUP\" \/>\n<meta property=\"og:description\" content=\"Current report No. 11\/2022Date prepared: 2022-23-05, at 4:14 pmAbbreviated name of the issuer: CELON PHARMA S.A. In connection with current report No. 9\/2022 of 20 April 2022 on Celon Pharma S.A. 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