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I love it when a plan comes together. More than Hannibal. Especially when it happens ahead of schedule.

This morning, Provention Bio (PRVB) announced that the FDA granted Breakthrough Therapy Designation (BTD) to teplizumab (PRV-031) for the prevention or delay of clinical type 1 diabetes (T1D) in individuals at-risk of developing the disease.

In the press release, CEO Ashleigh Palmer also confirmed what we predicted – the company is moving forward with plans to secure approval for teplizumab in “at-risk” patients without any further clinical studies.

“With this designation in place, we plan to leverage that landmark data, as well as the robust safety database from prior teplizumab studies, to support a registration filing.”

Look for shares to re-rate on this surprise announcement. How much and how quickly? Let’s discuss…

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