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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
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Hayır (No)
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oda_ExplanationTextBlock|
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In our statement made on August 5, 2021, we declared in summary 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 the medicine subject matter of the agreement is still ongoing before the Food and Drug Administration (FDA) and that it is targeted to launch the medicine by the last quarter of the year 2021. As per the information communicated by Sesen Bio Inc., the FDA replied to the application of the medicine bearing the "Vicineum" trademark on August 13, 2021 with an incompleteness letter ("Complete Response Letter") and Sesen Bio Inc. has requested a meeting from the FDA in order to determine the details and the next steps. This meeting qualified as Type A is expected to be held on the last quarter of the year 2021. In line with the clarified subjects with respect to the FDA approval processes, necessary public statements will be made in relation to the finalized issues pertaining to the license agreement. 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.