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Message: From IR

I suppose this means that whatever was said in the meeting with the FDA on Nov 13th, it was clear that persuing an NDA at current stage was not an appropriate move. From the post-CTAD conference call, DM noted that applying for breakthrough status would take 90-120 days. With the above response from IR stating that future FDA correspondence would be related to the confirmation of the breakthrough filing, should we take this to mean that we will not hear an update on anything FDA-related for the next 90+ days?

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