Wednesday, October 13, 2021 6:03:45 PM
Turns what people were saying on Stocktwits was wrong. They aren't submitting data from 200 additional patients. Durrant was talking about lenz's safety database that the FDA already looked at with the original application. He does say they will be submitting additional data in the near term but the 200 patient part is not correct. Below is Durrant's quote from the 3:45 point of the LD Micro Event:
"Importantly, there were no safety issues that FDA identified. They did note the limited size of the safety database. And that's understandable with a 520 patient study that's augmented by approximately another 200+ patients from other studies."
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