GTC Biotherapeutics, Inc.
GTC Enters into ATryn(R) Registration License with Bio Sidus Argentina
Published in Medical Letter on the CDC and FDA, May 2nd, 2010
GTC Biotherapeutics, Inc. ("GTC", OTCBB: GTCB) of Framingham, Massachusetts, and BIO SIDUS S.A. ("Bio Sidus") of Buenos Aires, Argentina, announced that they have entered into a Registration License Agreement under which Bio Sidus will perform all necessary actions to obtain sales authorizations for GTC's lead product, ATryn®, in Argentina, Uruguay and Paraguay. It is anticipated that the review process in Argentina will be completed within a fast-tracked period of no less than six (6) months from the filing of the dossier with the regulatory authorities. The dossier will be similar to that which was successfully submitted to the US Food and Drug Administration. All expenses incurred...
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