Replies to post #118996 on Bioelectronics Corp (BIEL)

[DewmBoom]

They submitted a tremendous amount of real world data for the FDA, but they seemed to want a clinical trial. That is why they approved for knee and foot.

The clinical trial on back is projecting a final result on January 21, 2018. I won’t be surprised if the FDA puts this on fast track especially since the UK NHS now granted them approval. We have an opioid epidemic and can’t comprehend what they are waiting for.

[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.

[JustGoDeep]

No back study has not been submitted yet.

The completion date is January 21st

and should go to FDA shortly after it if finished.

Expecting a FAST decision.

This was posted earlier today by Gramps.

https://clinicaltrials.gov/ct2/show/NCT03240146?term=Actipatch&rank=10

Note the recruitment has been finished but I don't know what date it was finished.

I should have been clearer that the recruitment was complete.