Ann: CEO to Deliver Featured Presentation at ISCT North America, page-40

  1. 3,812 Posts.
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    He knew that this is incorrect


    What do you base that on Leo? a hunch??


    More likely- FDA gave approval- Silviu had a few tears and went to roll out the product.


    Then the FDA wanted vials distributed according to patient weight AFTER APPROVAL- Post approval labelling/marketing requirements.


    Approval was for 1 vial or 4 vials with a code for each.


    After approval, that changed- so the supply chain needed altering from Singapore to the US distribution Centers- Paperwork would have needed to be updated at every treatment centre- packaging changed- contents of packaging even down to swabs per box. ALL new changes.


    How thrilled Silviu and the team must have been.


    Now when a patient requires treatment they may order for example a box of 4 and a box of two- 6 vials in total - they are anticipated to arrive at most of the major centres in around 24 hours.


    The vials have been ready since approval- the packaging supply chain was altered- launch is imminent.


    More than a hunch- it is based on the recent release of new codes and package volumes.



    Why the change- now I will have my hunch- they,the FDA, want to curb a blackmarket in our cells and future maufacturers cells.
    Excess is supposed to be destroyed- yeah right- at $200,000 a vial - woops I dropped it, yes I flushed it crushed it and stuffed it
    up my scrubs.



    I am as certain as I can be that the company will announce multiple dosings day 1- the queue must be backed up,
    unless we have been providing stock under the EAP.



    You go Silviu- most of your detractors couldn't spell mesemqimole.




    Reg


 
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