BIEL - BioElectronics - PDUFA Medical Device

[sgvscott]

I don't wish to take credit for this posting, this was copied from Sarkhan
Request Reminder for this Event 12-15-2009, in the FDA calender forum.
Just thought if any of you don't know about BIEL, here you go.

On 6/15/2009, BIEL Announced that it is filing an application with the FDA for 510(k) clearance to market its Allay Menstrual Pain Relief Patch product. The filing follows a VERY SUCCESSFUL double blinded, placebo controlled clinical trial in which 71% of women in the active group reported either complete elimination or a reduction in their typical menstrual pain symptoms. with 49% showing at least a 50% reduction in pain associated with dysmenorrheal (pain which is experienced during menstruation). The Allay Menstrual Pain Relief Patch is drug-free and is based on Pulsed Electromagnetic Field (PEMF) therapy, which is proven safe and effective in hundreds of peer reviewed clinical studies. Using advance semiconductor and micro-battery technologies, BioElectronics has achieved a technological breakthrough in shrinking PEMF technology into a very small form factor that has been packaged into a wafer thin patch that can be worn directly on the skin. The product is currently available over the counter in most counties outside of the United States. The FDA does not issue PDUFA action dates for medical device submissions and the 12/15/09 date is a six month review estimate for the 510(k) within an estimated range of 3Q-4Q09.

[kamavel]

FDA?s Woodcock Discusses Pain Management and Drug Safety in Nov. 26, 2009 Issue of The New England Journal of Medicine
This was posted on I-hub. It does not relates directly BIEL but could be positive for BIEL

[Kosta]

I liked BIEL, but at 874 million shares outstanding and then this article, you may want to have a read. This is from thestreet.com:

Biotech Stock Mailbag: FDA Playbook | Page 5 of 5 | Biotech | Financial Articles & Investing News | TheStreet.com

"BioElectronics enrolled college athletes into three different groups -- one treated with ActiPatch used for two days, a second not treated at all and a third treated with Tylenol for 90 minutes. The company says the study demonstrated that pain relief was greatest in the Actipatch group, followed by Tylenol, then the no-treatment group.
This study tells us nothing. Why wasn't there a true placebo arm, i.e., patients treated with an ActiPatch missing its battery? And the study wasn't blinded either, so patients knew the treatment they were receiving, which certainly skews the results of the subjective, patient-reported pain-relief scale employed in the study."

[sully5353]

i am more then confident that over the next month biel will be putting out an arsenal of marketing and increasing profits and sales tremendously..

the problem with most investors here is that they lack patience and want immediate results.. they have the attitude [ I WANT IT AND I WANT IT NOW ] what investors need to understand is that biel and its management are not magicians and building a business takes time and alot of effort..they also need to understand that biel has risen from .001 in march to its current pps which is a tremendous percentage increase in a short period of time..

biel has almost done that magic act with percentage gains even at it's current pps.. there are not to many stocks to compare with what biel has accomplished since march.. not big board,,OTC,,or pinks for that matter..

see i look at it this way...... everybody knows the potential of biel,, but they get frustrated because they are expecting for biel to make em rich and they become very emotional when the pps dips...

THE LESSON IS PEOPLE MUST LEARN TO BE PATIENT.. IF YOU HAVE SPENT TIME READING ALL THE GREAT INFO AVAILABLE ON THIS BOARD THEN YOU WOULD SURELY HAVE INSIGHT AS TO WHERE BIEL IS HEADING AND YOU WOULD HAVE THE CONFIDENCE TO HANDLE THE UPS AND DOWNS...

STICK AROUND AND BE PATIENT AND INVEST IN BIEL WITHOUT FEAR AND YOU WILL BE REWARDED IN TEN FOLD... EVEN IF YOU ARE A LITTLE LATE TO THE PARTY AND BOUGHT AT .10 CENTS.. BIEL WILL MAKE ALOT OF MONEY FOR YOU IF YOU UNDERSTAND AND ACCEPT WHAT I JUST SAID...

SULLY WISHES ONLY THE BEST TO ALL INVESTORS IN BIEL..

LOL SULLY

caveat emptor being removed and corrected !! yeah i already know just what the bashers are about to say.. so let me answer it before you say it !! biel is back to limited info but that is only because of the last unadited quarterly report but very soon they will submit the audited one and there status will go right back to current..

but the point is just like this re-class and approval bashers claim it will never happen ... well didn't they say the same about caveat emptor... oh it will never be removed,, biel is doomed... bla bla bla....

guess what ?? caveat emptor was corrected... and guess what else ??

B.I.E.L WILL BE RE-CLASSIFIED AND B.I E L WILL BE APPROVED !! AND GUESS WHAT ELSE ??? B.I.E.L WILL BE BOUGHT OUT !!!

AND GUESS WHAT ELSE ??? IT WILL HAPPEN THIS MONTH !!!

PS:::: I KNOW THE BASHERS CANT STAND THIS !! BUT I WILL WRITE IT ANYWAY... LOL SULLY !!!! HAHAHAHAHA..

remember something nobody can alter destiny.. regardless of what is said on this message board the cream always rises to the top !! its like the old saying :: you cant keep a good man down forever !!

well i feel the same goes for biel.. if biel is destined for greatness nothing or no one can stop it !! the more you try and surpress it the stronger it will become..

adversity can make or break you.. a loser will surrender to adversity but a winner will flip the script and use the resistance to only become stronger !!

i think biel is a winner and it will prevail.. and all adversity will only give biel the strength it needs to succeed..

lol as always !!! sully

[brianchale]

Lets hope we will find support at these levels. Ameritrade has ceased the trading of it which does not help.

[jg4550]

any reason why its been suspended on TD? I haven't been able to find anything.

[Jim Broski]

are we still on for 12-15-09 FDA?

[tibbys]

are we still on for 12-15-09 FDA?

it cant be and no, its a 510 clearance, not a drug.

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.

[Jim Broski]

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?????

[mmta1]

why is biel in the 'distressed limitied category' on pinksheet.com