Replies to post #162792 on Bioelectronics Corp (BIEL)

[DewmBoom]

That is very possible. If that is true, then Allay won’t happen before the end of 2019.

[DewmBoom]

It is possible that they could use this ALLAY CLINICAL TRIAL INVOLVING 91 women. Remember that the FDA rejected Allay back in 2009, but now the story is different after the late 2015 classification where Actipatch got cleared for knee and foot

http://www.bielcorp.com/biel/wp-content/uploads/2013/03/Allay-Clinical-Study-Ian.pdf

[Daytime_Lantern]

"Q3-4 next year", BIEL just might not be a business concern at that time next year. IMO, this company has been trashed!

GLTA!!!

[GetSeriousOK]

That is some good DD. Thanks! I also tried contacting the PUMPP PI but haven't received an answer yet.

If the Allay study has an ETA of May 2019 for completion.... that suggests RecoveryRx is probably on a similar timeline... and it's not clear what the company has to do to re-submit the Back Pain study for Women Only. I *think* the FDA said the knee and foot clearances won't work as a predicate device because those studies were not gender specific.

Meanwhile, revenues decline the O/S increases. And the SEC settlement has hit a snag and it looks like they are going back to court, which will cost BIEL more $$$ to defend -- making the SEC case more expensive in the long run than an early settlement would have.