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Posted On: 09/22/2025 5:12:11 AM
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Ohm, would you not think that an application for Breakthrough Designation might be successful after results, or even interim results, with the Phase II CRC trial?
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Are we maybe hoping the open label data will be so good we get conditional approval with these trials with phase 4 confirmation to follow?
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On the primary trial it's doubtful. With the follow-up study data it's a possibility.
Ohm, would you not think that an application for Breakthrough Designation might be successful after results, or even interim results, with the Phase II CRC trial?
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