Archives for category: Uncategorized

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

Advertisements

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.

 

small_obamarecoveryin9charts

Okay, I am assuming all who click on this are conversant with ticker symbol BIEL.

Looks like they diluted again, causing angst, but I am not completely negative about it.

For starters, knowing how Whelan operates, he’s looking ahead to some big news and expects to be able to raise some capital by selling into the ensuing frenzy. Downside is this is how he capped the run last time they got FDA approvals, but those were not the big one. This one is the big one. Allay and the migraine will be bigger in dollars, but this one is where BIEL will enter a whole new level.

There ought to be a press release when BIEL files the 510K for Back Pain/General Clearance.  The stock will spike, then retreat somewhat while waiting for the FDA to deliver a verdict.  There might be some news in the mix here.

Thinking in 4D chess terms, BIEL might be looking past approval to the day when they need to keep funding studies and keeping the lights on, so I grudgingly approve of the strategy. Many will wait for FDA approval and then move on. Some dilution helps BIEL on a spike, and might help shield them from a hostile takeover.

The dilution also guarantees that a reverse split is in the mix someday, but Whelan has always been pretty open about it, the caveat being it needs a major catalytic event to justify it, such as moving to NASDAQ or becoming profitable.. Otherwise it would be tantamount to throwing in the towel, in my opinion.

So, not to seem like Pollyanna, but dilution is a sign big news is coming. I have a portion I trade, and then a core position. Right now I’m holding–it typically backs off before big news though, but I can’t see a downside to announcing they submitted the 510K,which should be in June, so within 7 more trading days.