Linking and pasting this comment from IHUB. It is at least informative.

A while back, when BIEL was in the trips, I  came to the conclusion the best way to play this stock was accumulate and live correctly. This will play out, and it definitely seems like the stars are aligned. Trump wants a win on the opioid crisis going in to the 2018 midterms, and the ActiPatch is inarguably a step in the right direction for the future of Pain Management.

BIEL has run the FDA gauntlet with this before.  I imagine they overkilled that application. I’m pleased at how methodically BIEL is jumping through the hoops required to send the stock into orbit. Anyway, Tazzer is a long time poster on IHUB, and his comment is below. Bear in mind that a lot of the pick and shovel worked for this has already been done, such as safety and packaging, as Dewmboom pointed out the other day. Sounds like the FDA basically has to review a study. In a previous post here, I mentioned Keith Nalepka wrote the p value was well under the statistical limit to prove efficacy. With modern statistical software, these studies are pretty easy to analyze if set up correctly, and the FDA gave guidance as to how they wanted it set up.

In other words, let’s pray the process goes smoothly. The FDA (I imagine) does what corporations do, type up documents, pass them around for signatures, etc. It is a bureaucracy, so I don’t expect a miracle, but given what I wrote above and Tazzer’s comment, why wouldn’t this happen fairly quickly?

Thanks to Tazzer, by the way, I enjoy his/her posts.

Comment by Tazzer on timeline for FDA approval

“I realistically estimate 510K approval in 11 to 27 days expedited and 57 calendar days based on the normal timeline guidance.

Time line for statistical comparisons. FDA considers the start of the process the day they received a letter requesting guidance on a 510K. Usually takes 30 days before FDA gives guidance for submittal. BIEL had their review May 9th. So we are currently 67 days in the process. The numbers I suggest are reasonable. I am saying best case is 78 days worst case is 124 calendar days. In 2016 19% of 510Ks reached approval within 90 days from the beginning. Ours is expedited so hopefully we will be before 90 days.

https://www.emergobyul.com/resources/research/fda-510k-review-times-research

Refer to link for FDA 510K time guidance. Although it could be sooner given its an amendment to an existing 510K. Plus they already looked at the back study. Tick Toc…

Price will head towards at least a penny in next 27 Calendar days. GLTA!

Normal FDA 510K is projected to be completed in 60 calendar days once FDA approves 510K submission. BIEL received their approval on July 12 2018.

Just based on the regular not expedited we have no more than 57 calendar days till approval worst case scenario.

Expedited I would estimate 11 to 27 calendar days to approval would be my guess. Already day 2 so getting closer to approval.

https://www.emergobyul.com/blog/2014/01/us-fda-provides-510k-communication-timeline

https://www.fda.gov/AboutFDA/Centers

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Okay, for no apparent reason, here is my analysis of The Godfather Part Two. It’s a quiet night, and I have some YouTube movie on, waiting for the night to cool off a little.

I always liked these movies and the original books. Mario Puzo wrote the original novel about the ideal leader Machiavelli theorized about in THE PRINCE. Theories abound as to who the real Godfather was, with the most convincing being he was an amalgam of Mafia leaders.

Okay, here is my thesis statement about the movie: It really was Michael Corleone who attempted to kill Frank Pentangeli, not Hyman Roth.

Let me synopsize.

Michael Corleone was a mafia prince, who had recently moved out of New York to Nevada and was trying to go legitimate through legalized gambling in Las Vegas as well as in Cuba. He still had ties and influence in the New York rackets such as narcotics and prostitution, though.

One of his capos was a man named Frank Pentangeli, who went to Nevada ostensibly for a First Communion party for Michael’s son, but really to acquire Michael’s blessing to wipe out some hated enemies in New York, the Rosato Brothers.

Failing to get this, Frank became loud, obnoxious and abusive in a public dispute with Michael Corleone.  After he exits the room, Al Neri, Michael’s bodyguard says something like “Do you want him to leave now?” Michael replies to the effect “No, I’ve already made my plans, let him go back to New York.”

Al Neri’s character in the book was that of a New York City cop famed for his street brutality who was kicked off the force for beating a pedophile to death. The Godfather took him under his wing at that point and recruited him for The Mob, saying people often choose the wrong path in life at first. So, Al Neri was a top hitter and implied to be somewhat of a wartime consiglieri. Al was not an errand boy. He was not asking if Frank should be escorted off the premises. He was asking if Michael wanted Frank dead then, after insulting the Don so publicly and grievously. Michael’s reply meant Frank’s death had already been planned.

After Michael was almost assassinated that same night, he went on a tour where he told his Cuba collaborator, Hyman Roth, that Frank had tried to kill him. Then, he went to New York and told Frank that Hyman had tried to kill him.

When the Rosato brothers tried to kill Frank, they said “Michael Corleone sends his regards”.  Now, they are genuinely trying to kill him. Why would they lie to him at that point? It makes no sense, unless Michael secretly ordered the hit.

Later, in Cuba, Michael confronts Hyman Roth saying, “Who gave the order to kill Frank Pentangeli? I know I didn’t.” Hyman Roth doesn’t say he did, but rather that they had chosen to be gangsters and needed to understand that the gangster life was dangerous, and that he had lost friends too. If he hadn’t ordered the hit, it would have been to his disadvantage to admit the Rosato brothers were so out of control they had tried to kill Frank without permission from the bosses. Hyman was too smart to admit he did not know that Michael had not ordered the hit on Frank, basically.

So, Michael Corleone lives out the ideal of The Prince. He is completely amoral in pursuit of his larger goal. He lies to everyone. He sacrificed Pentangeli to achieve a larger goal, and he had planned on it before the insult. Frank was an obstacle, and a potential rival, who did not respect the street ability of the young Don.  His death would also make Hyman fully confident in their friendship, so the Cuba deal would go through, at which point Michael would take revenge for the attempted hit on him Hyman had orchestrated., but not before.

So, there it is. I think Michael Corleone really did try to kill Frank Pentangeli but also tried to blame it on Hyman Roth. It was like a master chess game, but Roth almost won, and would have if he had managed to kill Michael in Nevada.

Frank accepted his destiny after his mobbed up brother showed up at the trial where he was supposed to snitch. Now, one school says Michael implied he would kill the brother, but I propose an alternate. Since Frank had made himself unavailable to Mob rules by going State’s evidence and living on an army base, he had made his family targets of assassination.  The Mafia is known for not killing immediate family members of made guys, but only if they keep a normal schedule. If they can’t get to someone, they will kill his family. Michael was stating, by bringing Frank’s brother to the trial, that Frank’s family would be wiped out by his own brother, who had very strong beliefs in the Mafia Code.

What’s my point? Well, I watched the same movie as everybody else, read the book, and have a much different interpretation of it than everyone else seems to have. Mine makes it much more complicated and interesting, but I accept I could be wrong. Once you view it this way though, it does create some doubt. I’ve tried to explain this to people, but mainly get blank looks. Everyone has seen the movies, but for some strange reason few share my weird obsession with it.

*********

BIEL note. It makes sense for Bayer to make its move with getting ActiPatches in Dr. Scholl’s shoes before BIEL gets Full Expanded FDA Clearance. It takes time to get it up and running, so if they announce prior to Clearance, they can go full force as soon as Clearance is announced.

Also, once BIEL gets this Clearance, a deal made in the triple zeroes may look less attractive. Bayer would be smart to lock this down, and I say this in a completely objective way.

I’m saving a couple excellent comments for posterity and reference posted on the IHUB board. If you read this blog, I base my interest in this stock on primary research articles, and have analyzed them to the point of putting the data into my own statistical software (JMP). We actually got The Oxford Journal to issue a correction for one of their published charts based on my analysis of their data. For brass tacks, real time analysis of BIEL related FDA matters, IHUB is a good source. People reach out to the company, as seen below.

I’m pretty stoked about the new 510K submission for Expanded Clearance. I have a very vivid vision of going to Sam’s Club and buying one of those big First Aid kits and finding a couple of ActiPatches in it. I’m not too visionary, but sometimes a little ahead of the curve. People are going to go through the hoops some of have jumped through and start seeing the potential of this treatment.

If the Bayer/Dr. Scholl’s deal comes though, then you have that and the Expanded Clearance Application (world’s first electronic aspirin) in the mix. Explosive.

I post the comments below because I agree with them based on my research. This is complicated stuff

 

Courtesy of Markjohn

“Here is a reply about the word “trsitional” (sic) in the press release-

From Sree Koneru

Thank you for your message. The 510(k) that was filed does combine indications from the previous 510(k), which is why we are asking for “expanded” indications. The word “traditional” in the 510(k) is just to indicate the type of application prepared, as there are only three types. Seeking expanded indications automatically requires a “traditional” 510(k), since the other two types are for device modifications etc.”

Courtesy of Dewmboom.

“I am glad you looked at this and I did not want to confuse people with too much information here. I have looked at this very carefully well before now and here what I found.

If you look at the definitions of all 510Ks as well as the EAP. The circumstances of the Actipatch does not fit any of the definitions.

For the traditional 510K, Biel already waited months to get the FDA approval for knee and foot. So, they paid their dues their. As for the specifics of the abbreviated and special 510K, they do not fit the exact definition for why Biel is submitting when you look at them. The EAP does not apply because the Actipatch is not a life threatening breakthrough technology.

The only thing we know is that Biel has a pre-meeting with the FDA, and during that meeting the FDA gave them guidance on how to submit for expedited processing knowing the circumstances, evidenced by this quote:

Quote:


Dr. Koneru, who led the discussion, expressed confidence in the FDA’s constructive feedback. “We are pleased that the FDA viewed our data and statistical methods favorably. They have provided guidance on how to combine the back-pain study results, along with our previously cleared 510(k), into a single 510(k) submission for obtaining expedited expanded market clearance.”, he said.


As I indicated before, the FDA drilled this to the nth degree already and there is no good reason for it to take any longer than 30 days. Biel is not making any changes to the device, they are just showing a clinical trial for back pain to expand the approval into full body muscle and pain.

http://www.bielcorp.com/bioelectronics-receives-fda-pre-submission-approval-for-its-relief-of-musculoskeletal-pain-market-clearance-application/ ”

speakerhim

“My only guess as to why a traditional path was taken(if it was at all) is that the general actipatch for pain could have been guided to a traditional route to secure a solid foundation for all other applications for expedited clearance, including recoveryrx, allay, maxofacial, etc… ”

 

All interesting comments. We are dealing with a completely new portable approach to Pain Management. There is going to be some confusion every step of the way, but the important thing is the gamechanger got filed, and filed by a group with a proven history of success (3 FDA approvals, NHS in the UK, and the BRAUN deal.

20160713_14282320160713_142828

 

 

Alright, I’m winding down. Long hard day. Played some basketball around noon with the kids. My ten year old daughter fouls me every time I manage to get the ball.  I tried playing chess on a computer with her. If she lost, she would use the computer to backtrack every move to where she felt she went wrong. Then she moves for me until I’m checkmated. One thing I learned when she was a baby is she has a stronger will than me. I remember when she was about 6 months old, crying for a long time, so long I just sat down and watched The Godfather while holding her. She watched the whole thing, didn’t make a peep. Kids are great.

I want to write an extensive blog about The Godfather Part 2, or what should really be called The Frank Pantangeli Story. This is upcoming. I have some ideas about it. I rewatched it on the 4th of July weekend, as did all patriotic Americans. I don’t underestimate those kinds of movies. The writers of The Sopranos in particular, I suspect were reader of Dante Alighieri, The Inferno, in particularly. I didn’t pick up on this at first.

I’m amped up after watching Trey Gowdy attempt to examine Peter Strzok.  Bear in mind, if Hillary had won, this would never have happened. Strzok backed the wrong horse, blindly, and is now holding the bag for it. A lot of married women watching this effete, adulterous sycophant, and hopefully they vote.  Trump needs a few more seats in the midterms.

On the topic of Trump, I’m hoping his recent comments on the streamlining of the FDA process come to fruition.  The last time BIEL got approvals, it spiked a bit but not immediately. Today was bizarre, the never ending 10,000 share Ask. The stock has nowhere to go but up. I was reminded of an old movie about some Dungeons and Dragons playing nerds, where one of them cracks up and thinks he is living the game. His mom would hide a quarter under his pillow every night so he could pay the innkeeper (his Mom) for lodgings. He thought it was magical.

Anyway, I have been watching the stock for some time, and have never seen anything like it. Supposedly, out of about 60 million shares traded, about 48 million were naked short sales (see srinsocal’s post below from IHUB).

I have been checking for the Reg SHO FTD numbers since 5pm thinking that with the eternal 10k Ask Size there was mischief afoot. They finally materialized at 10pm. 

20180712|BIEL|48439188|0|58951639 

48.4 million shares could not be delivered today even with the delay of stats until 10pm. 

55.5 million shares were Buys at the Ask Price. 

2.2 million shares were Sells at the Bid Price. 

And yet we were capped at .0026 by MMs selling shares that they do not own, 48.4 million to be exact. 

Hopefully these SOBs will still be short when Dr. Scholl’s and/or the US Retail Partner hits. 

http://regsho.finra.org/FORFshvol20180712.txt ”

 

 

Dr. Koneru, who led the discussion, expressed confidence in the FDA’s constructive feedback. “We are pleased that the FDA viewed our data and statistical methods favorably. They have provided guidance on how to combine the back-pain study results, along with our previously cleared 510(k), into a single 510(k) submission for obtaining expedited expanded market clearance.”, he said.”

The linked quote above is being discussed again. Words have an exact meaning, as Ayn Rand used to say. In this context, the word “expedited” has an exact meaning. A Doctor would know this. He did not consult his thesaurus for a smarter sounding word than “speedy”.

I had a pretty busy day, so goodnight/morning to all.

 

20180120_173035.jpg

BIEL Files. Thanks to toomuchwasabi for posting this. This is the big one.

FREDERICK, MD, July 12, 2018 (GLOBE NEWSWIRE) — BioElectronics Corporation (OTC PINK: BIEL), www.bielcorp.com is pleased to announce that a Traditional 510(k) Premarket Notification for ActiPatch® was filed today with the U.S. Food and Drug Administration (FDA). The market clearance requested was “over-the-counter adjunctive use in the treatment of musculoskeletal pain”.

….”The 510(k) was prepared by the R&D team comprising: Kenneth McLeod, Ph.D., Director of Clinical Science and Engineering Research, State University of New York at Binghamton and Richard Staelin, Ph.D., Gregory Mario and Jeremy Mario Professor, Duke University, Ian Rawe, Director of Clinical Research, BioElectronics and Sree Koneru, Ph.D., VP Product Development, BioElectronics. Dr. Koneru, who spearheaded the 510(k) effort, said, “We are confident with the strength of our data and overall application. Given the FDA’s prior knowledge of the data and prior clearances, we believe that the 510(k) will be processed in a timely manner.”….”

https://globenewswire.com/news-release/2018/07/12/1536528/0/en/BioElectronics-Files-FDA-Application-for-Treatment-of-Musculoskeletal-Pain.html

 

Flow Chart of The New 510(k) Paradigm

 

 

“…There is a tide in the affairs of men, Which taken at the flood, leads on to fortune. Omitted, all the voyage of their life is bound in shallows and in miseries. On such a full sea are we now afloat. And we must take the current when it serves, or lose our ventures....”

What a great writer Shakespeare was, how apt and timely he remains. I’m living in a place where for the first time in my life, star gazing is really “a thing” on a consistent basis. I have mainly dwelled in the mountains or in cities, and both tend to be obstructed as far as celestial observance goes. I’ve seen some amazing sky shows in the mountains, but you have to pick your spots. George Soros, a thoroughly fictitious person, most likely, supposedly has a birthday on the day of the Perseid meteor shower. Maybe he does. He grew up speaking Esperanto, supposedly, the language for globalism in the future. If you can believe that. Anyway, Soros’s birthday is a great night to watch meteors, even fireballs. You see one of those and you never forget. (August 12). Don’t get him a present except pray for him if you are especially enlightened, he is going to need some prayers where he is going.

Lately I have been watching a planet, Jupiter, I think. It started as the brightest “star” in the northwest sky about two months ago, and has been heading west ever since. Some very old religions are based on the movement of planets. Mainly people trying to take the tide at the flood, sometimes for very evil purposes, sometimes not.

Even in Christianity, the stars play a part. The Annunciation (the announcement by the Angel Gabriel to Mary that Jesus was conceived) occurs on March 25th, with Christmas on December 25. Saint John the Baptist was born three months after Jesus’s birth announcement. After the birth of Jesus (the winter solstice marking the shortest day of the year, the sun would begin to increase. He must increase, but I must decrease” (John 3:30). So Saint John was preparing for the birth of Jesus, since Saint John was born on the longest day of the year, and the days began to diminish. After the birth of Jesus, the days start to grow longer.

March 25th is also considered the historical date of the creation of the universe in Judaism, as well as the day Abraham almost sacrificed his son Isaac at God’s request, so the birthday of Judaism.

Three months is significant in gestation of babies. Before ultrasound, it was probably about the time a heartbeat could be detected.

I think people getting away from studying the esoteric aspects of Christianity is a big mistake. It does challenge historical faith in this regard–it makes one wonder if events played out this way, or if the timeline was created after the fact in attempt to take the tide at its flood.

“The fault, dear Brutus, is not in our stars,
But in ourselves, that we are underlings.”

Julius Caesar (I, ii, 140-141)

 

20180503_121141

 

 

On July 1, 2018 MSCI Inc upgraded BIOELECTRONICS COR from 4 to 5.

Posting this just because…MSCI gets into the BIEL act now and then. The more the merrier.