Replies to post #85861 on Bioelectronics Corp (BIEL)

[Lufrance]

Thank you Dewm.
BIEL

[User_347763]

The 510 k date has been adapted the day the last FDA meeting took place.
I have to admit I disagree with most of your far too optimistic posts but with your last few posts you seem to hit the nail exactly on the head.

[slopak]

Tnx dew keep up the good postings!

[yankee55]

Excellent research DB.......the final pieces of the Actipatch puzzle are being put into place and then the picture will show a FDA green light!!

[Det_Robert_Thorne]

That 10/3/2016 date appears to be section update

The 510K premarket notification has been modified on 10/3/2016.

That 10/3/16 "Page Last Updated" date appears to be some sort of update of the web pages in that FDA search section, and doesn't apply to the data in the records themselves.

Here's the link you provided to the ActiBand search:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=k022404

Click "New Search" and the blank search form shows the same 10/3/16 page updated date.

Click the "DeNovo" header to bring up that search, and the blank search form for that page also shows it was updated 10/3/16. The same is true for the "PMA", "HDE" and "Classification" search pages.

Now, go back to the 510(k) search, and perform a device search for "Aleve Direct". While the decision date is 12/22/2015, the "Page Last Updated" is still the same 10/3/16 date.

Clearly, that 10/3/2016 date is when the search page itself was updated, and that is a completely different thing from updates to the records themselves.

[stockdarockk]

Those updates are NOTHING to do with BIEL. Some buy not researching enough and following misinformation. BIELs situation goes from bad to worse come Thursday. The ACTIBAND which theyve hoped on, for any submission, goes away. Not only will this 510k not show up this week, the newly filed De Novo process, just hits a new speed bump come Friday.

If BIEL used their best case, they would have filed the De Novo months ago, using any ACTIBAND data with the FDA. They chose not to and lied to investors. Of course they always hope. What CEO wouldnt share that they still hope? But facts will only hurt those buying 7s or higher. BIEL will get this, and will dilute into any increases. Play accordingly.

BIEL has ZERO active 510ks for ACTPIATCH. To quote a FDA update page for everything, to something as just for BIEL, will only hurt even more investors. Some want any hope, but it has to be accurate hope. Not only did they lose this key FDA item, but the 28th of October could be the start of the closing down of BIEL. Hold shares if you want. They soon may just be a reminder of things not to touch. Surly nothing is in the works to change any of this. Watch.

Buyers now, will just get caught and stuck in this mess, just at a higher price.

You see how it was used that 5 Million out of a hundred Million went at 7s was a good thing. Nope it was a tactic used many times by the note holders. Typical tactics to bait even more unsuspecting. Rush in to buy and you just lose more. More of BIELs hopes, even for the new De Novo filing get dashed next week.