BIEL - BioElectronics - PDUFA Medical Device

[tibbys]

Thanks for telling me that it's a "510 clearance, not a drug" but that's not what i asked!

WHEN IS IT COMING Mr. smart guy?????

a 510 means its not a specific date, they(the fda) say it 'will probably take about 6 months' from when they file, which was 6/15/09, that's why they say 12/15/09, this is just a rough estimate, it means its about six months. It could have been approved before then, or even after, right now they are a little behind, plus if you read the thing above me from the guy from the company, it will take even longer because they filed the classes type of fda approval wrong. A drug decision date is more of a guideline and it should be completely reviewed by then.

[lifetime45]

With the 30% rise in the PPS on Friday, it is eerily similar to the run up in regards to the Tylenol study that resulted in a huge sell off on the news. Are we going to see the same thing early next week--- a PR and then sell off?

[yanni]

I believe no one knows. Many are going to take this 30% and never look back.

[Nordic]

Depends how soon BIEL submit their reclassification submission and file their audited financials. From what Joe Noel posted at Yahoo last week, these should both be posted within days, and that was as at 9th December.

IF these are filed within the next day or two, we'll likely see this recent spike hold and establish a new support. If not, it could go right back down to 0.04 again, although personally I think that is oversold, all things considered.

There is a lot of talk about 12/15 approval, but I don't see that happening since BIEL have not even submitted the new reclassification docs yet. The only approval possible would be under Class III, and while that is good, Class II and over-the-counter sales are far more preferable.

Once (if) FDA approve reclassification, then the submissions are a shoe-in, imho. All of them - although the FDA might want more safety tests on the Allay patch to cover any concerns about causing birth defects down the line or something like that. As far as I'm aware, efficacy is already well covered, but you never know with the FDA.. they approve some crazy stuff, and deny others that people are crying out for.

For those that missed it, here is a copy of Joe Noel's post on Yahoo boards on 9th December:

Update from Joe Noel 9-Dec-09 01:38 pm

Hello Everyone:

Back by Popular Demand - Here are the latest updates.

Reclassification Application - Personnel at the Company are in process
of preparing the application requesting reclassification from Class
III to Class II. The application will include several reports from
scientists and physicians that will discuss the technical aspects of
the product and arguing that the device is extremely safe and is
incapable of causing harm. Additionally, the application will include
many other supporting documents. We expect the application to be
completed very shortly and to be filed with the FDA soon, likely over
the next few days – and possibly even sooner. This is obviously an
important application, so the Company is being very careful to make
sure all of the proper documentation is included. Its worth noting
this is a separate application from the others that have been filed.
Because the FDA is actively reclassifying Class III devices cleared
under 510K (such as BIEL’s), we expect a rapid review from FDA. In
fact, we had been in discussions with the actual reviewer and they are
presently awaiting our data.

International Developments – The Latin American launch is currently
pending and we are optimistic about our prospects. We have contracted
with one of the leading Latin American oriented advertising firms and
the ads will be seen in most major Latin American countries. DRTV
campaigns are also scheduled for Germany and Turkey. Canada is also in
the schedule. These campaigns were designed by some of the best
advertising firms in the business with extensive track records of
success. We believe these international programs, along with other
programs targeting Asian countries that are currently being designed,
will yield substantial revenues in 2010.

The Audit – We met with the head auditor last night. We are happy to
say that there are no outstanding issues raised - everything looks
good based on what they are telling us. Very good news. The audit
began at the end of October. Audits typically take approximately 60
days. The auditor’s review has been done and we are expecting their
completed report in the very short term. I would like to emphasize
here that we selected a solid medium-sized auditing firm in order to
add credibility to the process. Accounting and auditing firms often
give lower priority to smaller companies and sometimes these clients
end up at the bottom of their auditing pile, thereby requiring a
little more time to complete the process. We should have the final
report any day according to the auditor. This should accelerate
movement to the OTC - All excellent developments.

Movement to OTCBB - We are currently in process of executing a
strategy to move off of the pink sheets and over to the over-the-
counter (OTC) market. Andy and I will be meeting with the bankers in
New York on Thursday and Friday regarding this process. We believe the
completion of the audit should significantly facilitate the movement
of the Company’s stock off the pink sheets, which in turn should
result in the resolution of several issues with the electronic
transfer of shares through brokerage house back offices.

Our Level of Confidence – It has not changed one bit. We think 2010 is
going to be a fantastic year. Thanks for all your support. We believe
everything is on track.

Joe Noel

and Joe added later on another thread:

Everyone:
The new application that is going in is specific to reclassification.
Not a modification of the 501Ks for Allay and ActiPatch. FDA needs to
reclassify this device anyway - this application will give them the
info they need to make the right decision.
Joe Noel