Replies to post #149077 on Bioelectronics Corp (BIEL)

[jaysolano]

That's great China Cat...

Because IF FDA picks BIEL/Actipatch anywhere in the top selections, then I can't see how FDA would NOT want to first provide BIEL with clearance on their pending application.

It just wouldn't make FDA look very good to say "THIS IS ONE OF THE WINNERS OF OUR CHALLENGE!.... but we still need to finish looking at their 510(k) filings..." I think they're much smarter than that.

Definitely something to think about in terms of trying to predict WHEN that FDA Clearance might get dropped on BIEL.

[seven-up]

Re: Fw: Accepting Applications June 1 to September 30, 2018: FDA Innovation Challenge for Devices to Prevent and Treat Opioid Use Disorder

Andrew Whelan BioElectronics <bielcorp.com>
To: M


May 30 at 5:37 PM

M

I hope you and the family are well.

Thank you for the notice. Very interesting. We are thinking it through to incorporate it into our pending musculoskeletal pain FDA application. We are searching the literature to document the connection between musculoskeletal pain and the use of opioids.

Andy

On Wed, May 30, 2018 at 11:38 AM,

[art2426]

Did they say how many 'winners' they will choose in this CHALLENGE? Just one or could there be many?

[DewmBoom]

This is a brilliant move by BIEL to bolster the exposure and grab attention here in the USA. Opioid is the buzz word these days and having Actipatch/RecoveryRx in the driver seat as a chosen treatment to reduce dependency or eliminate opioid use completely in certain cases is going to be Huge for BIEL.

It looks to me that a lot of things are happening to BIEL on the positive side in late Q3 and Q4, 2018.

[JustGoDeep]

Biel is Going to be a Winner-of-the Innovative-Challenge

Exactly fits the description.

Name me another device even remotely close.

Winning this Challenge and FDA Clearance are separate items.

One is not necessary for the other.

https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm609150.htm

MONSTER!!