Sunday, November 03, 2024 4:37:16 PM
Think I do now understand why did not apply with fda. On the presentation on Musellafoundation with Mimivax ceo from July 2023 for next trial they are to randomize 3 to 2 treatment to control. They asked fda (minute 33 or so) if they could use external controls. FDA responded could use external control only if they could find patient level matched controls and they could not find such data. Sad for all the trials that have taken place they do not share the patient level data. Now UK application and not fda makes sense
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