Bioelectronics Corp (BIEL)

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This is the last I've heard about Allay

E & E Communications <[e-mail]> Tue, Feb 18, 2020

Allay Menstrual Pain Study Status Update

The Allay study is a randomized, double-blinded placebo-controlled study that was conducted at the University of Birmingham, UK. We are still waiting for the principal investigator to send us the data from the Allay clinical study. We do have confirmation that the study is complete, so it is a matter of the investigator transcribing the data and making it available to us. Since the study was conducted independently, we cannot request that this process be expedited. Once the data comes through, it will take us several weeks to analyze the data and determine whether study outcomes are in alignment with what the FDA expects in clinical submissions for new indications. After these steps, we will work with the FDA to assess the regulatory pathway that needs to be pursued (510(k) vs DeNovo etc.) to obtain market clearance for the Allay product.