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Skerrets new job, page-10

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    @Starlink ... originally in Post #:71396789 you inferred a possible December 7 2023 discussion / decision on amendments to Astodrimer Sodium after the 1 September submission .... and then you went on to say that in Post #:71928440 you expect a "TGA delegates interim review expected Feb 2024" ... do you still think is likely by the end of the month ?


    IF this in fact holding up the TGA approval / rejection of Viraleze I guess it is important when this review drops although in the letter from the new CEO the other day she claimed that the UK Viraleze study data will also be used to "support regulatory processes ...................., including Australia" - sadly if this is the case, then this will only delay the TGA decision further as the new data submission will enable a pause and then of course a restarting of the revision clock ?



    upload_2024-2-26_8-34-47.png





    https://consultations.tga.gov.au/tg...ms-43--accs--37---joint--35-november-2023.pdf

    upload_2024-2-26_8-16-9.png
 
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