The way I see it, I think IMU will only apply for the fast track after they finish the shortened trial as recommended by the IDMC. Don't forget, what we had recently was just an interim data. And with the way Leslie Chong works so far, she will only do something that is confident of success. Hence , finish off this 'shortened' Phase II and then apply for fast track together with a letter of recommendation from the IDMC.
My question is, would the company be required to make an announcement to the market once they submit the application to fast track Her-Vaxx? I believe they would be required to do so as that is sensitive material. What do others think?
Ann: Imugene Enrols First Cohort of PD1-Vaxx Clinical Trial, page-49
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