Ann: Cyclopharm USFDA Update, page-16

  1. 18 Posts.
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    I'm sorry but this announcement smacks of further incompetency by management.

    In January 2021 there was much hype around the final stages of USFDA approval.
    A site visit by the FDA to Kingsgrove was planned for March 2021, 102 Nuclear Medicine Technologists were lobbying for an expedited approval and plans were underway to support the strong US demand for Technegas. Including the possibility of an additional director being appointed to support this forecasted market growth. It all seemed to be a fait accompli.

    That then got turned on its head when approval was rejected. Why?
    Seems like management had well and truly put the cart before the horse as there were a plethora of shortcomings in the companies submission.

    In June 2021 we were told by Mr McBrayer that: "We have complete confidence that we can address these matters and do what is required to
    expedite this process. We now have clarity as to what will satisfy the USFDA’s expectations
    and will commence work on the response immediately.”
    Further McBrayer claimed that these matters and FDA approval would be secured in around 9 months.

    So here we are in 2022 and another timeline for approval has been tossed up to us long suffering shareholders. Less the momentum of last years planned US rollout.
    So folks, you can put a line through the 9 month McBrayer claim and based on the last "update" we may get a response in March 2023!! Whooooo Hooooooo!!
    Lets see if there will be another sting in the tail with a further CR this year!!


 
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