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English
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oda_MaterialEventDisclosureGeneralAbstract|
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Evet (Yes)
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Hayır (No)
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oda_DateOfThePreviousNotificationAboutTheSameSubject|
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05.08.2021, 16.08.2021, 10.12.2021
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oda_DelayedAnnouncementFlag|
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Hayır (No)
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Under the announcement we made on August 5th, 2021, we have stated that our subsidiary EİP Eczacıbaşı İlaç Pazarlama A.Ş. ("EİP") has executed a license and supply agreement with Sesen Bio Inc., a company based in the United States of America (USA), for the marketing and sales rights of the medicine bearing the "Vicineum" trademark in Turkey and Northern Cyprus; that the marketing authorization process of this medicine is still ongoing before the Food and Drug Administration (FDA) and it is targeted to achieve the market supply of the medicine by the last quarter of the year 2021. Also, under the announcement we made on August 16th, 2021, we have further stated that, the FDA has responded on August 13th 2021 with a Complete Response Letter to the application of the medicine bearing the "Vicineum" trademark; and under the announcement we made on December 10th, 2021, we further stated, as a result of the meeting held between the FDA and Sesen Bio Inc., additional clinical trial is required to be conducted in order to be able to make an approval application to the FDA again and that it is planned to hold a meeting with the FDA, called the Type C meeting, in early 2022 to discuss the additional clinical trial protocol.
This time, under the information provided by Sesen Bio Inc., it is stated that; at the Type C meeting held with the FDA on March 28th, 2022, an agreement was reached on the large majority of the Phase III working protocol and statistical analysis plans, and for the remaining items that remain open, it is planned to continue to meet with the FDA in the next months.
The necessary public announcements will be made on the issues with certainty with regards to the issues that have gained clarity in relation to the FDA approval procedures.
This statement has been translated into English for informational purposes. In case of a discrepancy between the Turkish and the English versions of this disclosure statement, the Turkish version shall prevail.
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We proclaim that our above disclosure is in conformity with the principles set down in “Material Events Communiqué” of Capital Markets Board, and it fully reflects all information coming to our knowledge on the subject matter thereof, and it is in conformity with our books, records and documents, and all reasonable efforts have been shown by our Company in order to obtain all information fully and accurately about the subject matter thereof, and we’re personally liable for the disclosures.