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Is it Possible to Gain Regulatory Approval Following a Single-Arm Study?

In this case study example - yes.

Veristat developed a thorough regulatory submission strategy and novel efficacy endpoint for the treatment of an ultra-rare and aggressive hematologic malignancy that led to FDA and EMA approval following a single-arm...

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Veristat Joined the Battle Again - in 2022

Another Successful Cycle for Survival Ride Raising $90K To Support Rare Cancer Research

 

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