SPL 0.00% 10.5¢ starpharma holdings limited

DEP always first, page-14

  1. 5,499 Posts.
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    ITF won't be happy, that is for sure. I mean they have a business to run, and may want to pursue other opportunities ... or will they be patient and put their business on hold for 18 months and risk another delay or a failed trial.

    However, the issue at hand is the upcoming FDA meeting... so I am trying not to speculate much further as there are still so many unknowns.

    But what is known is that the FDA have requested a confirmatory trial, and SPL want to see if they can meet those requirements with existing data ... as I said above it will be an uphill battle.. but they have every right to fight that battle, spend as much consultancy dollars as they want ... but at the end of the day the FDA will need to give them a very clear 'green light' for them to lodge another CRL with the same data.

    There is always risk when it comes to an approval meeting, they may agree conceptually (as you can see with our SPA) .. but when the data hits the hands of the assessor - that is when decisions can be made.

    As an investor we only ask to be given facts so we can make informed investment decision. SPL have made it difficult to do this - but if we dig a little deeper the facts become clearer and those who make the effort can make more informed investment decisions.
    Last edited by stockrock: 15/03/19
 
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