MSB 2.08% 94.0¢ mesoblast limited

CRL or Approval???, page-48

  1. 7,738 Posts.
    lightbulb Created with Sketch. 2037
    I agree.

    There's really not very much relevance comparing historic advisory committee recommendations to FDA approvals etc.

    Each product will be judged on its own merit by the FDA, taking into account not just the ODAC recommendation but other significant variables: safety, need, trial outcomes, method of action, consistency in manufacturing etc.

    Expect more fear mongering and negativity in the next few days.
 
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