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"Buying Shoes"? Really!! Why?
GLTA!!!
Why would one expect to sell their product if that product is absent from the consciousness of prospective customers? BIEL, itself, won't advertise its product. The Big Pharma license holder of Actipatch sales in several countries, as far as I know, are not advertising the product. So what's going on here folks? Something is askew here, for sure!!
GLTA!!!
So, what you are implying is that this Actipatch hoopla is, and has always been a fraud from the beginning, clinical trials withstanding. So, have I interpreted your position correctly?
GLTA!!!
BIEL doesn't need the blessings, nor the endorsement of that ole FDA to be successful. BIEL, just get out there, sale, and make something of yourself, "B"!!
GLTA!!!
If the VP of Sales is such a 'Hot Shot", then lets see some big time sales numbers! Only when measurable, appreciable, sales results are registered by BIEL, then and only then there should be accolades flung in the direction of any BIEL official. That's My Take!!
GLTA!!!
One should be aware that there have been those who sketched out a notion of selling a product on a napkin at the kitchen table, and in a few months are making millions. Thus, IMHO, the essentials that made it possible for their success were the following items:
1. They possess a great product (i.e., A product for which
people have some need or, people are attracted to the product
through Emotional Stimulation to purchase(i.e., ads)
2. They formulated a great business plan
3. And they advertised their wares
BIEL can put a check by #1 for having a great product, but the other two, well, make our own assessment!
Note: The FDA is not mentioned anywhere above. IHMO, the point is well made, and you can
take that to the Bank!!
GLTA!!!
One should be aware that there have been those who sketched out a notion of selling a product on a napkin at the kitchen table, and in a few months are making millions. Thus, IMHO, the essentials that made it possible for their success were the following items:
1. They possess a great product (i.e., A product for which
people have some need or, people are attracted to the product
through Emotional Stimulation to purchase(i.e., ads)
2. They formulated a great business plan
3. And they advertised their wares
BIEL can put a check by #1, but the other two, well, make our own assessment!
Note: The FDA is not mentioned anywhere above. IHMO, the point is well made, and you can
take that to the Bank!!
GLTA!!!
'43, I agree! It appears that BILE's management can commit one colossal misstep after another, but still there will be those who will surface with excuses for them. Furthermore, those excusatory factions are quick to point the finger at some convenient straw wman , blaming them for BIEL's misfortunes. This Is Quite Strange And Sad! But from my viewpoint, what is more important is hopefully, someone can soon convince the CEO that gaining FDA clearance is not the end all. His focus should have always been on... Sales! Sales! Sales!... and also building a brand through advertising. To achieve this, it might be necessary for the CEO to give up a slice of the company through leveraging. To reiterate,
the FDA shouldn't be the main focal point at this time. Sales! Sales! Sales! Is The Ticket At This Time, IMHO!! Of course, this very point has been made by others, as well.
GLTA!!!
Well, maybe your assertion is correct. Another thing, BIEL has given an element of Big Pharma the reins in the form of a license to market and sell their product in several countries. Permit me to inquire, is anyone on this board aware of that Big Pharma entity being engaged in pushing/promoting BIEL's product, in a serious way. If there is evidence of that, well I stand corrected. The logical question remains, why would any Big Pharma entity be a champion of BIEL's success? We must think about these activities in a skeptical and analytical way.
GLTA!!!
I agree, but more than a "stupid PR" needs to be changed. For months now, I've been posting essentially what your post is projecting. But, something is very wrong here! Maybe there maybe an element of corruption at play here, in regards to how this company is being managed. Some may say this theory is all wet. But the manner in which this company is being held back is illogical, unless there is profit being made and redirected underground, so to speak. May expound on this notion at a later date.
GLTA!!!
How soon? That could be a couple years out! Eventually, BIEL will, hopefully, hit pay dirt. But as long as BIEL's current management follows the business operational track it's presently on, then IMO BIEL's great success is in the offing, by a great distance.
GLTA!!!
Let it be a Friendly Takeover, or a Hostile one, if need be! But yes, it needs to happen! By substantiated accounts, BIEL has a winner of a product, even if the ladies are in its efficacious favor at the moment. But even so, as it stands today, the potential of this product is just withering on the vine.
GLTA!!!
Just how long do you think this company can sustain itself as a business concern with "setbacks" and "speed bumps" of this magnitude, while contemporaneously not generating revenue? Well, I think I can give a plausible answer to the question, and that's not very long from this point forward! IMHO!!
GLTA!!!
Well DB, as it was once famously so well said, thus, "Every Man Should Know His Limitations!" Apparently, BIEL is learning that the hard way!
GLTA!!!
Well, it might be "very promising" if that indeed is actually true.
GLTA!!!
There is no excuse for BIEL to be that incompetent at this juncture of its existence. Ridiculous and Sad!!
GLTA!!!
If BIEL feels as if they were dealt with unfairly, shouldn't they retain legal counsel? On the other hand, if they don't seek legal representation, then I think we all can read between those lines.
GLTA!!!
As shareholders, why don't we demand that BIEL provides a detailed account regarding the FDA's stated reason(s) for the clearance denial. Start by giving us the delineated trial numbers associated with the (Not Good Enough Men's data), and the apparent (Acceptable Women's Numbers). Furthermore, if the female numbers were apparently good enough, then why won't BIEL resubmit with a female bias. It's reasonable to think that this could be done in very short order, since the trial metrics remain in BIEL's possession, so why not do this? There are a lot of questions which need to be answered. At least, acceptable answers might provide some degree of closure to this highly disappointing situation.
GLTA!!!
I will always wish my fellow BIEL shareholders Good Luck! We are not being served well by the FDA, nor by BIEL. Those are the facts!
GLTA!!!
Question! Where will BIEL acquire the necessary funding to sustain itself as an on going business concern? Well, I have to admit, my previous question was a rhetorical tease. Thus, maybe it's safe to say we are about to witness some high powered dilution, which will further devalue this company, Big Time! Going forward for BIEL just might be a nightmare in the way of dilution. Not Good At All!!
GLTA!!!
DB, very good points!
GLTA!!!
"Restraint and patience are called for here." Oh, please!! Enough of this misplaced hero worship, already!! Yes, the CEO founded the company, but presently BIEL is a publicly owned entity, which means investors also have a stake in the company. Get It! The shareholders expect the CEO and other officials of BIEL to operate it with some degree of successful competence. IMHO, by all accounts, this is not being done at this time. This is a very disappointing situation!!
GLTA!!!
"Q3-4 next year", BIEL just might not be a business concern at that time next year. IMO, this company has been trashed!
GLTA!!!
DB, how long has Allay been on the market, thus, in use by women?
That's what I've been saying for months now... this BIEL brain trust thinks they are the smartest guys in any room, especially the CEO. He has a history, more than once, of trying to push the limits and get by with skullduggery. If BIEL's decision makers had played fair and collected the trial data and extrapolated that male efficacy stats were not up to par, thus, eliminating men's trial results from the 510k. Thereby, resolve to submit the 510k with a women's bias and secure the clearance. Subsequently, make a lot of money and buy time and do additional research on the men's side and eventually crack the code for greater efficacy, as per the product, for men. But no, I'm slicker than everybody else and I'll win. No, not all the time you'll win!
GLTA!!!
"Here's to saving a buck and losing a million." You Got It!!
GLTA!!!
This needs new management in the worst way! Now! The RS can come later!
GLTA!!!
Hey Dude! Hope Springs Eternal!!
GLTA!!!
Ya know! Perhaps, the recent actions by the FDA could be a retaliation by proxy on behalf of the SEC. You Never Know!
I would think these two federal agencies engage in routine bidirectional communication, and data exchange with one other. Furthermore, it's a pretty safe bet they possibly hold similar philosophies regarding cheaters. Oh! Ya! A Big Disdain! Of course, the Whelan family has a problematic history with the SEC, which involves being loose with regulations. But they also have a similar past relationship with the FDA, for committing a similar offense, thus, in violation of regulations. Well, That's My Take!!
GLTA!!!
'65, the trial numbers must have been abysmal for men, in order for the FDA to justify denial of BIEL's clearance. I would like to know what those numbers were, please, somebody, anybody?
GLTA!!!
Please, stop it with this retired baseball player. My Goodness! This guy can't solve BIEL's problems. Isn't this guy Keith a former baseball player? BIEL is up against some "Big-Time" foes here. BIEL needs some first rate business wizards to help pull them out of this deep hole, IMO.
GLTA!!!
This guy Keith has no political sense, thus, he is part of BIEL's problems, IMO.
GLTA!!!
What! You have got to be kidding! This guy is dug in like an Alabama tick!
GLTA!!!
You're correct!! Something needs to happen! This whole situation is ridiculous!!
GLTA!!!
If the so called "CEO" was indeed a real CEO, he would have been out front immediately, being a man, and giving the shareholders some explanation regarding what happened over the last couple of days. But he won't do anything of the sort, because he doesn't know what happened and don't know what to do next. The so call leaders of BIEL are bush leaguers, all of them. They are not ready for prime time, as they say! They are a joke!!
GLTA!!!
P.S. BIEL should have aroused public opinion about it's product(i,e. advertised, some how) and also made its bid for FDA approval a political issue, as well. Just Unadulterated incompetence!! Please, Amazon, Microsoft, Google, somebody buy these jokers out and give the public a product that it deserves.
GLTA!!!
Has BIEL stated when they expect to submit the revised 510K based on women success rate? Does the latest FDA decision to deny clearance for BIEL places an overall negative light on the technology embodied by BILE's product(s)? Furthermore, how does the latest FDA decision effect the bio-electronic industry at large?
GLTA!!!
If what you say is true, that's fraud sir!
You know, it's conceivable that BIEL attempted to slip the less than favorable trial data for men past the FDA and got caught. Because logic would suggest that such consequential, significant data of that nature should have been discussed during pre-submittal meetings between FDA and BIEL.
GLTA!!!
P.S. Instead of touting the fandom of Actipatch by a retired baseball player, BIEL officials should have been courting politicians on both sides of the isle, Progressive and Conservatives alike. It's surprising how things get done in your favor when you have friends in high places. As I recall, there was an instance where the VP of sales (that Keith guy) attacked a politicians on tweeter, a democrat, if I remember correctly. Again, if I recall correctly, the matter had nothing to do with BIEL, this guy just lashed out. Not Smart!! You never know whence help may come when you project universal friendship, especially when business is involved. Keith should take lessons from the big boys, they grease palms on both sides of the isle. What that VP did just shows a lake of sophistication. Case and point, because of a sophistication deficit, BIEL is in the predicament which it's experiencing today, IMO.
I keep asking this question... what was the men's trial data as compared with the women's? Did BIEL ever publish this info in a comparative format?
GLTA!!!
"A huge Overreaction" you say. Well, what happened yesterday set us back more than 12 month. Well IMO, that's a big deal. Furthermore, the items you delineated in your post are not currently money makers for BIEL. A company that doesn't generate money dies. Just how long do you think BIEL can survive without generating working capital?
GLTA!!!