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.

 

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Wimped out and put on the AC, now waiting for it to kick in. Real humid day, right before a thunderstorm which might make it worse if the heat evaporates the rain water quickly.

I made my daughter pancakes for breakfast this morning. I am getting pretty good at making them. I have a whole system where I stir up an egg, spices (ginger and cinnamon) vanilla, water, and almond extract, and then gradually dose it with the dry portion, usually mix, while whisking. Meanwhile, I have been getting the pan to optimum temperature, which is process critical.

Then, I pour the prepared batter onto the pan lightly coated with olive oil, cook until bubbly, and then flip. I then add chocolate chips, or chocolate buds this morning. By the time they melt, the other side is done.

If I deviate from this recipe, my daughter will not eat the pancakes. She is not adventurous with her breakfast in particular. I admire this trait. It seems opulent. When I was a kid, we ate what was given or starved.

We bought the AC years ago when the baby was born. I forget what it cost. I think I got it delivered. It rattles now, from a toy the kid put in it years ago when a toddler and we were never able to fish out. It works, though. Even since I started writing this it has cooled off considerably.

I was reading about the oldest person in the world, a 129 year old Russian woman. I read about her when she was 128 too. She said, at 128, that she wanted to die and that God was prolonging her life as a form of punishment. At 129, she was still pretty much a downer. She said she still wanted to die, and had never been happy a day in her life, just all hard work. She was born in 1890 or something ridiculous. Got exiled to Kazakhstan by Stalin, that was a low point. She was tiny and shrunken, but was still giving interviews. I hope I look that good at 129.

She had outlived all her children, which would really suck, but was surrounded by her granddaughters, these big, husky, happy Russian girls who looked like they exceeded their quota at factory work. There was a lot of love in that picture.

Getting downright temperate in here.

Savor each moment for what it is. This was the advice given to Ice T by the the former CIA agents who had brought him up to the Alaskan wilderness to be hunted to the death in a sort of therapeutic death match. Surviving The Game, it was called. I must have watched it a hundred times, minimum. Good advice.

 

Worth pointing out that today is 6/19/18, meaning and that Bioelectronics is supposed to file the Full General Clearance 510K by the end of June. Supposedly expedited clearance could see it approved by the end of July/begining of August at a minimum.

 

Last item BIEL filed this back in 2009 they got rejected, but there has been great progress since then. NHS approval gives them respectability, and BIEL wised up and got better at the process.

The 2009 510K submission drove the stock from levels comparable tot where it is right now to 3 cents a share in a few weeks, so about 10x.

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The FDA has a new program to expedite review and apparently now has a marketing division.

 

I believe the ActiPatch is disruptive technology, with billions at stake. All the studies and regulatory hoops have been completed. Now, the FDA, which would not exist in a free society, has just to do its job and issue General Clearance.

You have to make a choice in thirty seconds for your migraine. You can either mainline attenuated Botulism Virus for it or apply an ActiPatch.

Okay, 10 % are weirdos and want to shoot botulism in their face so they can look like Nancy Pelosi.  The first to market is going to own this thing.

 

What I pasted below reads like a sick joke in light of 9 years of regulatory struggle with the FDA. Free the ActiPatch and hire marketers. The FDA will not pick the winners until November. Bioelectronics should seriously consider suing the FDA. Why should the FDA get credit for bringing the ActiPatch to market? It is essentially the same device as 9 years ago when the FDA rejected it. The trouble with Andrew Whelan is he still thinks American government institutions are respectable. Those days are long gone. Now the FDA is simply out for what they can grift.

 

 

 

“As part of efforts to combat opioid crisis, FDA launches innovation challenge to spur development of medical devices ? including digital health and diagnostics ? that target pain, addiction and diversion

BIEL WILL BE PART OF THIS PROGRAM WITH RecoveryRx…….HUGE

“This new effort builds on the success of previous work to take a collaborative approach to promoting medical device innovation and safety, such as the 2012 challenge that led to multiple new approaches to treat life-threatening, end-stage renal disease,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “The FDA stands ready to provide significant assistance and expedite premarket review of applications to help bring innovative devices that, if properly instituted, could help those at risk for addiction or treat those who might develop opioid use disorder. We also hope that in turn these novel products may also help pave the way for the development of future products that build on the latest technologies.”

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm609188.htm

So, Andrew Whelan CEO of Bioelectronics corporation went on the radio today, and the stock has remained the same, which is a great omen. Usually, when you let him near a radio mike, the stock just starts dropping. He is too nuanced and intellectual for the radio, and gets into sort of a message drift.

The radio requires real focus, the term talking points comes to mind. Just get a couple of central ideas you want to relay and pound them.

I listened once. I am so cynical. This FDA innovative thing I touched upon in a previous blog seems like a stalling tactic by the FDA. The FDA will do all the advertising if accepted? I read the thing, and they announce it in November. So, if selected, it will be announced in November.

The record of BIEL in the past, is not sterling. Broken fax machines, Joe Noel, we have been burned before, but this is a big idea. A lot of times (all the time) when I talk to people I feel like they are little kids in how they view the world. A study of history will indicate a trusting view is usually punished.

There is a new migraine pain treatment coming out. Huge money is at stake. How does the FDA cover its ass with its pharmaceutical masters and still present a show of fighting opioid abuse (o-pee-oid)?

Stuff the upstart company into a “new Innovative ” award package, offer the pie in the sky…I mean, who really trusts the FDA? It is absurd. As a Libertarian, mainly, I support the free market deciding which is the best product, not some bureaucrats who have been screwing this up for at least a decade with BIEL. What the hell does the FDA know?

Anyway, beyond that, glad they have a new box design. F—K.

This blog is about what interests me. What interest me falls into a general pattern.

Lets read the tea leaves for Bioelectronics. I’m doing this for the non-obsessives. I’ve learned that some things I take for granted logically do not always follow naturally for others. So this is for people interested in BIEL.

  1. The last time Keith Nalepka was on the radio, he said he would be back within forty days with news, basically about the Dr. Scholls deal getting finalized.
  2. Premise-the Dr. Scholls deal can’t get finalized until General Clearance for Pain is granted by the FDA, along with with the wound healing application. This will make the deal better, and will be what the ad campaign is based on. So Bayer/Dr. Scholls needs this before this goes live.
  3. Two days ago, Keith Nalepka said he would be on the radio within the next three weeks.
  4. Sum= Keith Nalepka expects to get General Clearance within the next three weeks, and to be on the radio discussing the Dr. Scholls deal, finalized.
  5. So, General Clearance within the next three weeks?

Steps 1-5 make sense to me. If Nalepka committed to the radio talk, read between the lines.

A general comment—I expect wound care to be easier than general muscle pain, data wise. People are wooses. I don’t expect an honest answer about pain from most people. It’s tough to gauge. Given enough cases in a well run study, yes, you can generate valid data, but I innately am suspicious of gripers.

Wound care, however, is a beautiful study. Just take a thousand similar wounds, treat 500 with an ActiPatch and 500 with a placebo, monitor objective criteria like healing time, swelling dissipation, scar formation, rate of infection, there are multitudes of data you can can chart, graph, correlate. Now you’re talking my language. How do you feel doesn’t work for me, especially when half the people in the study might just be whiny crybabies who want an opioid prescription.

Why do you think the German giant medical stock BRAUN like BIEL for it’s wound treatment in that recent major deal? Because you can prove wound healing with data with no debate really.

Anyway, it will be interesting to see how it plays out. I have to thank Keith Nalepka for his transparency on Twitter. Follow him, let’s make him a Blue Check.  Expect a press release next week as yet another European country announced it will pay for the Actipatch. Sweden, which has one of the greatest health care programs in the world, joined the UK in adding Actipatch to their national health care program. I thought Germany would be next in line because of BRAUN, but I will take Sweden, a world leader. It is exciting to see all this finally playing out.  I’m rooting for Andrew Whelan and the team. It’s like the Old Man and The Sea, as  I have said before. He caught the biggest fish in the world, and for all the BIEL shareholder’s sakes I hope he can bring it home. Something tells me the sharks already had their best chance.