Bioelectronics Corp (BIEL)

[kidnova]

I've read through the Allay study and I can't find anywhere in the study that they assessed Analgesic use. It states:

Patients are to take, if needed, any medications that they might normally take for pain relief during a normal menstrual cycle.

However, pain meds were not tracked or recorded so there's no way to know how many drugs were being taken in addition to the Allay application. The FDA is going to have a hard time drawing a conclusion from the Allay study without that data. It sounds as if BIEL believes that the only study they currently have that will be acceptable to the FDA is the molar extraction study and that study is still underway so there's no way to know if there will be statistically significant results or not.