Cartoon courtesy of markjohn62, post # 161602. Sums it up nicely, I’d say. Thx.
Disclaimer - Yes, I have already purchased more shares (& will continue) b/c I know that PEMF therapy is the future of pain relief and medicine in general. I envision and expect to see great success for BIEL and the subsequent investment reward but this recent denial b/c of gender differences while acknowledging its effectiveness for both genders is a bridge too far. Beyond absurd, ludicrous. We should have been cleard 10 years ago, easily.
The Birth and Evolution of the FDA: The Galactic Kahuna took the ‘Children-of-the-Corn’ (AMA) and procreated them with Komodo Dragons (big Pharma), their evil spawn was the FDA who, in turn, grew into adulthood, to become the comatose vanguards of the deadly status quo. This cabal created, oversaw, nutured, condoned and inflicted upon us the opioid crisis. Not everybody, most are good people, good neighbors. When required, these droids are awakened, given activation codes, and off they go, to render professional opinions like our most recent unfortunate experience. Only their komodo-like stench belies their existence, in human form, as they sit staring aimlessly, awaiting further instructions. Why do you think perfumes and colognes were invented?
We are forced into a situation in which there is no escape, and few alternatives. Take 3 steps forward, then 2 steps back, repeat. This is the game - stall, present a glimmer of hope - repeat. All b/c big pharma cannot tolerate competition. They are not interested in a level playing field, never have been, and never will be. Remember the obnoxious bully in middle school who got his way or ruined it for everybody? Same thing - bigger, nastier, more sinister bullies, with limitless funds with which to control and undermine any potential threat. We are that threat, and will continue to be, the mouse that roars.
We must face up to the unpleasant fact. We got sucker punched and for good measure, face slapped. In the challenge, we lost to vaporware! That sting will be felt for months (years?) to come. Rogue statistician?, deliberate act?, coordinated bear raid? - who knows. Within the last few weeks we have learned there has been a flurry of interest from whom?, large companies? 50% drop in sp in one day? then large block buys? little too convenient? Bayer knows our operation inside and out, top to bottom, and now they sell Dr. Scholls? What is going on?
Our initial, knee-jerk reaction seems to be re-apply for full body clearance again, for women only. I’m skeptical to say the least. So, more clinical studies required? 3-6 mths minimum. Will weight be an issue? How about race? age? Let’s say we get it, then what? We will hear raucous peals of laughter from coast to coast, worldwide. The fda won’t be the object of ridicule, we will for having been so gullible. Gender differences? - that’s a joke, right?
Today’s letter from the President, Andy Whelan, didn’t say much. However, I did learn that lots of data had been submitted to clearly answer any concerns the fda might have had re: data inconsistencies. The conclusion, on my part, is the fda could not care less about the data, it was about delaying the company and PEMF technology. We played by their rules and got humiliated. The excuse of gender differences would be laughble if it wasn’t so pathetic. Unaccountable arrogance from the fda and smug satisfaction from big pharma.
We are continuing with everything else which is good. A bump in the road, yes, but it did knock our vehicle out of alignment a bit. Submitting the Allay application is the way to go. Full body for women application is only playing right into their hands and a stupid waste of precious funds and resources. Forget the full body for now. Come back to it after we achieve some success, fund a new study and nail it down. Focus on the other revenue generators, our future, support them. The fda wants to grind us down to dust, wear us down thru attrition.
And never, ever deal with the fda w/o legal representation. No matter if it is on the phone, email, or esp’ly in an actual meeting. Power only respects Power. Rational arguments ‘win the day’ with adults, not the fda. When a respectable, solid legal team is present, the shenanigans stop. Learn this lesson well.
Is this a ‘tempest in a teapot’ or should we go into crisis mode with all hands on deck? I would err on the side of caution and start brainstorming with all options on the table. Yea, we got suckered. Too much complacency and presumption of clearance and acceptance into challenge. We were ripe for the picking and got plucked alright. But now we have a choice. We survived and will use this as a learning experience. Cowering and begging not to get hit again (eg - resubmit for women only) is not one of the options. Getting smart, reconfiguring our game plan and implementing it agressively is. This fight is far from over. Bielieve it.
As much as I enjoy taking well deserved shots at the fda, BIEL needs to examine the operation itself, get our own house in order, and rally the troops. To that end, I have a list of stuff. Few of the following are original. Kudos must go to lots and lots of people who care deeply for this company, its’ continued well being, and PEMF technology. So, let the ‘stepping-on-toes’ exercise begin.
1) HIGHEST PRIORITY - Appoint Social Media Coordinator / Director - not someone doing ‘online’ in addition to other responsibilities - we need to set fire to social media, light it up - chat rooms, forums, video events, online testimonials posted everywhere, etc. We can’t control what madness the fda comes up with next but we can do this. Get on every list that has anything to do with pain or opioids, et al. Posting on facebook or in response to something isn’t good enough. We need to go on the offensive, big time. Proactive, not reactive. Social media cuts across borders and is cost effective. People, pain sufferers are online. The word ‘Actipatch’ should be everywhere. Get people asking about and requesting Actipatch. And then do more, and more.
2) We need an ‘angel' event right now, the prez letter was not it. Maybe not a ‘deux ex machina’, but close. I know there are those working in the background. Fingers crossed. Godspeed to you. Thanks.
3) Why the hell wasn’t the VA deal given a full-throated, widely distributed press release ??? An interview, sending an email to those registered and a couple of articles is not good enough, pretty lame actually. Contact all chapters of VFW & American Legion and all orgs that have anything to do w/veterans - offer all vets (and active duty personnel, too!) 50% discount on all products - until we saturate that market. If there is a supply issue, say so. Don’t spill the beans but rumor, sarcasm, and apathy fill a void with lightspeed velocity.
4) Canada - Somebody please tell me Canada still actually exists. Vancouver, Toronto, Quebec, Montreal, and Ottawa. Enter social media.
5) NHS - We really dropped the ball on this. When I heard about what was going on with the CCGs my heart sank. Somebody didn’t do their homework. This is, and continues to be, a major blunder that should not have happened at all. The good news is now we know and are dealing with it.
6) Healfast (for pets) - DewmBoom’s call here - I would sacrifice food off my table to provide good, safe medical care for my dog. I’m not alone. This is the forgotten and neglected stepchild. Sad.
7) Finances - what can we afford? - we have to be smart with the money. Re-submit for women only ???
8) Spokesman (or woman !?) - this relates to points #2 and #7; a familar face connected to Actipatch is a solid, reliable link to the consumer. Obviously, Orel H is the odds on favorite (pun intended).
9) Infomercials & shopping shows - admit it, you’ve watched ‘em and bought some product. They work. Can we afford it?
10) And finally the topic most painful. Andrew Whelan. The Man, The Visionary, who made all of this happen. Andy has been the inspiration and bulwark. He is to be remembered as a pioneer in the recognition and acceptance of PEMF therapy. He will be feted and celebrated for generations to come. His succession has to be broached, part of the conversation. Historical memory manifest in Chairman of the Board is priceless. Maybe start to transfer (quietly) CEO duties to Kelly (?) or a designate, bit by bit. Many thanks to Andy. Too many accolades is not enough. I type these words ever so relunctanty. I would be most happy to be wrong here.
In years to come, this point in time will be seen as an inflection point in BIELs trajectory to general acceptance; success as a brand and as a company. We cannot waver. Our resolution and determination must be steadfast with laser beam focus. Remember that scene in Moneyball where Brad Pitt’s character is talking to the GM of the Red Sox? The GM says, I paraphrase, “… the first one through the wall takes all the hits …”
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