Bioelectronics Corp (BIEL)

[pearsby09]

They first have to submit the back data trial to the FDA. The FDA will take their sweet time reviewing the data for possible subsequent approval. I am concerned with the N=60 data set. the FDA often times requires larger or additional trials for confirmation and validation. Hopefully there was an established SPA between BIEL and the FDA so that does not happen. However, I have learned the hard way too many times that the FDA is very unpredictable.