Have to say I do think the reaction to the COVID 19 ards trial results is a massive underestimation of its importance .
in the first place it allows the fda an out with respect to its decision on gvhd as these are very similar inflammatory conditions . All the changes in bio markers etcetera will provide the evidence that the fda was looking for . You would have thought that they are already in discussions with the fda on all of this . In my opinion they would be mad to publicise it as the one thing you want to give a regulatory authority is face so they don’t look stupid when they change their mind . The ards trial result provides exactly that . i Would bet though that they are in deep discussions with the fda as it has been a long time since that ridiculous decision took place .
secondly I think it is an absolute no brainer that Novartis continue the agreement that they signed up to . They will have seen all the activity levels and the reduction in them in the ards trial and would have come to the conclusion that this works in all sorts of areas . Let’s not forget that their agreement is not just confined towards ards.
you could make the argument that whilst approvals have been deferred , the results are really rigorous and if they have to do follow up trials they are looking at an open goal as they know exactly the patients to target . More importantly we now know that this therapy needs to be given sooner rather than later making it a mainstream rather than a salvage therapy .
fingers crossed
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