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Posted On: 08/16/2022 10:46:33 AM
Post# of 145890
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Re: HHIGambler #127703
Well, on March 31st SK told us that the clinical hold should take 8-12 weeks to clear up and then I was hoping they were still working on the BLA so that it might be submitted as soon as it was cleared up. Neither of these things sounds likely to be soon now. The BLA is becoming more and more concerning. Wasn't the timeline to have the full thing resubmitted by last October? We received the data from Amarex either at the end of last year or early this year. If the data is so messed up that they can't fix the BLA (because of Amarex's crappy work) then I think that needs to be conveyed to us.
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