{"id":24433,"date":"2022-05-24T09:42:52","date_gmt":"2022-05-24T09:42:52","guid":{"rendered":"https:\/\/celonpharma.com\/?p=24433"},"modified":"2022-05-24T09:42:52","modified_gmt":"2022-05-24T09:42:52","slug":"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\/24\/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 &#8211; 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\">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 qualitative portfolio including outcomes of manufactured and released series of Falkieri, (Celon\u2019s esketamine DPI), which meet the FDA\u2019s quality criteria.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The Company will be informing about the progress in regard of this project in the US in subsequent announcements.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>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<a class=\"excerpt-read-more float-right\" href=\"https:\/\/celon.group\/en\/2022\/05\/24\/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 &#8211; 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":[26],"tags":[],"class_list":["post-24433","post","type-post","status-publish","format-standard","hentry","category-general-en"],"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 - 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\/24\/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 - 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=\"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\u2019sRead more &raquo;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/celon.group\/en\/2022\/05\/24\/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:site_name\" content=\"CelonGROUP\" \/>\n<meta property=\"article:published_time\" content=\"2022-05-24T09:42:52+00:00\" \/>\n<meta name=\"author\" content=\"Ma\u0142gorzata Siewierska\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Ma\u0142gorzata Siewierska\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/celon.group\/en\/2022\/05\/24\/positive-outcome-of-fdas-assessment-process-of-the-ind-application-concerning-the-commencement-of-a-clinical-trial-for-falkieri-celons-esketamine-dpi\/\",\"url\":\"https:\/\/celon.group\/en\/2022\/05\/24\/positive-outcome-of-fdas-assessment-process-of-the-ind-application-concerning-the-commencement-of-a-clinical-trial-for-falkieri-celons-esketamine-dpi\/\",\"name\":\"Current report no. 11\/2022 - Positive outcome of FDA's assessment process of the IND application concerning the commencement of a clinical trial for Falkieri (Celon's esketamine DPI) - CelonGROUP\",\"isPartOf\":{\"@id\":\"https:\/\/celon.group\/en\/#website\"},\"datePublished\":\"2022-05-24T09:42:52+00:00\",\"author\":{\"@id\":\"https:\/\/celon.group\/en\/#\/schema\/person\/e0ffc863fc928f3fd9bd67757492badf\"},\"breadcrumb\":{\"@id\":\"https:\/\/celon.group\/en\/2022\/05\/24\/positive-outcome-of-fdas-assessment-process-of-the-ind-application-concerning-the-commencement-of-a-clinical-trial-for-falkieri-celons-esketamine-dpi\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/celon.group\/en\/2022\/05\/24\/positive-outcome-of-fdas-assessment-process-of-the-ind-application-concerning-the-commencement-of-a-clinical-trial-for-falkieri-celons-esketamine-dpi\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/celon.group\/en\/2022\/05\/24\/positive-outcome-of-fdas-assessment-process-of-the-ind-application-concerning-the-commencement-of-a-clinical-trial-for-falkieri-celons-esketamine-dpi\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/celon.group\/en\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Current report no. 11\/2022 &#8211; 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)\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/celon.group\/en\/#website\",\"url\":\"https:\/\/celon.group\/en\/\",\"name\":\"CelonGROUP\",\"description\":\"\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/celon.group\/en\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Person\",\"@id\":\"https:\/\/celon.group\/en\/#\/schema\/person\/e0ffc863fc928f3fd9bd67757492badf\",\"name\":\"Ma\u0142gorzata Siewierska\",\"url\":\"https:\/\/celon.group\/en\/author\/malgorzata-siewierska\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Current report no. 11\/2022 - Positive outcome of FDA's assessment process of the IND application concerning the commencement of a clinical trial for Falkieri (Celon's esketamine DPI) - CelonGROUP","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/celon.group\/en\/2022\/05\/24\/positive-outcome-of-fdas-assessment-process-of-the-ind-application-concerning-the-commencement-of-a-clinical-trial-for-falkieri-celons-esketamine-dpi\/","og_locale":"en_US","og_type":"article","og_title":"Current report no. 11\/2022 - Positive outcome of FDA's assessment process of the IND application concerning the commencement of a clinical trial for Falkieri (Celon's esketamine DPI) - CelonGROUP","og_description":"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\u2019sRead more &raquo;","og_url":"https:\/\/celon.group\/en\/2022\/05\/24\/positive-outcome-of-fdas-assessment-process-of-the-ind-application-concerning-the-commencement-of-a-clinical-trial-for-falkieri-celons-esketamine-dpi\/","og_site_name":"CelonGROUP","article_published_time":"2022-05-24T09:42:52+00:00","author":"Ma\u0142gorzata Siewierska","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Ma\u0142gorzata Siewierska","Est. reading time":"1 minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/celon.group\/en\/2022\/05\/24\/positive-outcome-of-fdas-assessment-process-of-the-ind-application-concerning-the-commencement-of-a-clinical-trial-for-falkieri-celons-esketamine-dpi\/","url":"https:\/\/celon.group\/en\/2022\/05\/24\/positive-outcome-of-fdas-assessment-process-of-the-ind-application-concerning-the-commencement-of-a-clinical-trial-for-falkieri-celons-esketamine-dpi\/","name":"Current report no. 11\/2022 - Positive outcome of FDA's assessment process of the IND application concerning the commencement of a clinical trial for Falkieri (Celon's esketamine DPI) - CelonGROUP","isPartOf":{"@id":"https:\/\/celon.group\/en\/#website"},"datePublished":"2022-05-24T09:42:52+00:00","author":{"@id":"https:\/\/celon.group\/en\/#\/schema\/person\/e0ffc863fc928f3fd9bd67757492badf"},"breadcrumb":{"@id":"https:\/\/celon.group\/en\/2022\/05\/24\/positive-outcome-of-fdas-assessment-process-of-the-ind-application-concerning-the-commencement-of-a-clinical-trial-for-falkieri-celons-esketamine-dpi\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/celon.group\/en\/2022\/05\/24\/positive-outcome-of-fdas-assessment-process-of-the-ind-application-concerning-the-commencement-of-a-clinical-trial-for-falkieri-celons-esketamine-dpi\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/celon.group\/en\/2022\/05\/24\/positive-outcome-of-fdas-assessment-process-of-the-ind-application-concerning-the-commencement-of-a-clinical-trial-for-falkieri-celons-esketamine-dpi\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/celon.group\/en\/"},{"@type":"ListItem","position":2,"name":"Current report no. 11\/2022 &#8211; 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)"}]},{"@type":"WebSite","@id":"https:\/\/celon.group\/en\/#website","url":"https:\/\/celon.group\/en\/","name":"CelonGROUP","description":"","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/celon.group\/en\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Person","@id":"https:\/\/celon.group\/en\/#\/schema\/person\/e0ffc863fc928f3fd9bd67757492badf","name":"Ma\u0142gorzata Siewierska","url":"https:\/\/celon.group\/en\/author\/malgorzata-siewierska\/"}]}},"_links":{"self":[{"href":"https:\/\/celon.group\/en\/wp-json\/wp\/v2\/posts\/24433","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/celon.group\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/celon.group\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/celon.group\/en\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/celon.group\/en\/wp-json\/wp\/v2\/comments?post=24433"}],"version-history":[{"count":0,"href":"https:\/\/celon.group\/en\/wp-json\/wp\/v2\/posts\/24433\/revisions"}],"wp:attachment":[{"href":"https:\/\/celon.group\/en\/wp-json\/wp\/v2\/media?parent=24433"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/celon.group\/en\/wp-json\/wp\/v2\/categories?post=24433"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/celon.group\/en\/wp-json\/wp\/v2\/tags?post=24433"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}