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So tell us why FDA gave the company a green light for BLA...

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  1. Leo65
    847 Posts.
    lightbulb Created with Sketch. 95
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    29/08/24
    23:35
    Post #: 75444663
    So tell us why FDA gave the company a green light for BLA resubmission after looking at the additional data on the potency assay. If what you are saying is true, FDA would still insist on a new trial for validation of the potency assay, but it’s clear that is not the case any more.
    MSB Price at posting: 95.0¢ Sentiment: Buy Disclosure: Held
    Likes Created with Sketch. 19  Upvote
    lightbulb Created with Sketch.  Great analysis
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