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"Costs related to winning 510(k) clearance for a medical device that were directly related to satisfying Food & Drug Administration rules average $24 million, according to a Stanford University report. More than three-quarters of the cost to bring a medical device from concept to the U.S. market is spent clearing regulatory hurdles, according to a Stanford University report."
Now, Stanford says the average cost is about $24M. It's been reported that BIEL/AW has spent about $35M, thus, getting FDA clearance. Well, there is a delta of $11M, relative to the two aforementioned figures. So, I guess this is one of those things that makes you go, Hmmm! I ain't saying, I'm just saying!!
GLTA!!!
What is the date associate with this material? A rehash of old news has little value to inform in this situation.
GLTA!!!
Just curious, where did the yardstick of "1-18 Days" come from?
GLTA!!!
-- "Pure Facts! $20-Million Profit Can Easily Be Attained" --
The two conjunctive statements above form an oxymoron, by definition. Just saying!!
Well, Ok! Enough of the hypothetical and theoretical, everybody is waiting for a big dose of reality, BIEL. Come on BIEL, you go out there and make something of yourself! Ya! Let's see the money! For starters, that $20-Million in Profits would look nice, yes, quite nice on your balance sheet. But, Oh! Well!
GLTA!!!
Well Said!!
GLTA!!!
Wow! Those are Insane Numbers! That ain't no Newspeak either! Those numbers are bad by any measure as related to a company's share structure, for sure!!
GLTA!!!
IMO, in regards to the current clearance push by BIEL, the FDA will continue to ask for additional information, right up to the point of saying, No Go! Thus, BIEL, once more, won't be enjoying the proverbial Montecristo Puritos. So Sad! IMO, this whole BIEL saga of failure, is orchestrated. For, IMO, no company with as many, apparently, accomplished individuals within it's ranks, could be so utterly clueless. Now, you may ask... for what reason this mess is occurring? Well, your guess is as good as mine. But, IMO, in order to be so consistently, so almost perfectly incompetence, thus, there is more than an outside chance there is some degree of calculated intent present. IMO, even the most ardent BIEL supporter of this perpetual fiasco, would have to reach deep into his/her fantasy bag of credulity, and chalk up BIEL's numerous missteps as organic probability. IMO, no way all this mess is just happenstance!! Well yes, only my take!!
GLTA!!
Please, what is the story you're getting from BIEL?
GLTA!!!
What the heck was that??????????????????
GLTA!!!
If you have read some of my posts in the past, I contend just that fact; thus, IMO, all this CEO dysfunctional is deviously calculated, thus, intentional!! For what reason this is taking place, well, your guess is as good as mine.
GLTA!!!
If what you state is fact, then there is only one term that will suffice to describe this situation, and that's madness!! To reject any reasonable deal offered by a big player like CVS would be ludicrous! At this point BIEL needs a lifeline and maybe CVS could have served that opportunity, but no. Well, that's BIEL for ya!!
GLTA!!!
P-High, I agree, there are some positives which can be cited per the CEO's statements. But he has not justified, to my satisfaction for what it's worth, why he refuses to advertise his product. As I have stated before, if AW needs to leverage an Ad campaign, I'm sure his daughter would float him a short-term loan, if he couldn't get funds from any other source. IMO, he would only need a "short term'er", for sales of Actipatch would skyrocket when the pain suffering public gets wind of what this product could possibly mean for their quality of life. IMO, one would have to be a "%$#@!@!*&" to fail with this product!
GLTA!!!
The following text is taken from the CEO’s latest written public statement: “The CVS sale was a test as part of store remolding program. Our product did very well without an advertising and promotional campaign.” Hmm! So, it appears that the CEO is bragging in regards to his decision not to inform potential customers that his product was/is available for purchase, and that's something to be lauded. What could be the reason why this person would want to impede the sale of his product? This is High Strangeness folks! With that second statement, he’s revealing his awareness of the importance of advertising, but he chooses to starve his company of it. Why? Here is another observation, he reduced the Actipatch down to an impulse purchase. Thus, rendering it as an unplanned, random, purchase. Actipatch is not a candy bar, or a snack cake. This device is a serious product, with serious benefit to be had by its user. Actipatch has great potential to deliver affective pain relief for the masses, and this person is denying those sufferers of that greatly needed aid. Shame! Shame!
GLTA!!!
P.S., Please don’t anyone give me his talking points about not having the resources to wage an ad campaign. For as I understand it, his daughter and her company are worth millions. Thus, theoretically, if BIEL found it necessary to seek financial leverage for a promotional campaign that would be the obvious source.
Fool me once, shame on you, but fool me a hundred times, shame on me, in spades!!
GLTA!!!
Of course, the following statement is taken from BIEL's most resent PR: "As a side note, the Company is preparing to file its response to the FDA’s request for additional information on the postoperative pain 510(k) application, within the next week." What????!
Why is there always "additional information" requested of BIEL during the FDA clearance process? Is the culprit the FDA, or is it BIEL? Though it's JMO, but I would tag the latter. By now, wouldn't a reasonable person think BIEL should know exactly what data/information the FDA expects to receive, in order to give clearance? This is ludicrous folks! BIEL has at least one PHD on staff who is intricately involved in the development of their product, and they can't figure out what to provide to the FDA to obtain clearance. Something is seriously wrong here folks!!
GLTA!!!
What about the FDA clearance for the RecoveryRX? Does anyone think BIEL will get the approval nod from the FDA on that one? I have very little faith in that group to scratch where it itches, let alone get approval from the FDA.
GLTA!!!
P.S. Fool me once shame on you, fool me a hundred times shame on me!!
" I'm starting to feel optimistic that things will be clarified, soon, very soon! Oh! Really! Well, as they say... Hope springs eternal!!
GLTA!!!
The SEC should be called in on this mess! Nobody can be this clueless, if they tried!! Scam! Scam! Scam! The whole crew is in on the scheme, and you can take that to the bank!!
GLTA!!!
P.S. I hate to say I told you so, but told you BIEL wouldn't get clearance from the FDA!!
"Transformational"... I think that word has been associated with BIEL before. Yes, as a matter of fact, I think Mr. Keith himself designated 2018 as the transformational year for BIEL. Well, how did that turn out for everybody? There are instances when shareholders voiced their frustrations on this board, in response to the lack of communication from BIEL's management. But if shareholders are expected to except pablum such as that disgorged in that message propagate by Mr. Keith, then what value does management communicating with shareholders have? Just Pathetic!!
GLTA!!!
THIS WHOLE THING IS INSANE!!!
Oh! It's Russia and the Ukrain now! Next week it will be BIEL just signed a deal with aliens on Mars! I hate to say it but this is folding out to be a classic shell game. Thus, keep'em guessing, and apply the hook with always another possibility just over the horizon. One must ask, why are they doing this when they have a product that obviously works. Thus, Actipatch has the potential to deliver great benefit to the human condition. They are driving this company into the ground, why? It's insane! Full Stop!!
GLTA!!!
P.S., This Keith fellow should resign if he deems what is going on at BIEL is unacceptable, relative to his moral expectations and professional standards. That's It In A Nutshell!
Hate to say it, but if it looks like a scam, walks like a scam, and indeed smells like a scam, then it just might be a scam. Sorry!!
GLTA!!!
I'm afraid BIEL will get nothing from the FDA. IMO, if the FDA had any intention to give BIEL clearance, they would have done it already. IMO, the FDA is waging a scorched earth campaign against BIEL. Sorry! Stormy seas ahead, IMO!!
GLTA!!!
"Monday is a time for change" Well, I won't beleive it until I witness it! Yes, I know it's cynical, but what else could be expected from a disappointment riddled BIEL Long?
GLTA!!!
We all are familiar with the cost differential between the two products. But the point I thought I made quite adequately, is
that BIEL has got to "Get off the schneid", so to speak, and get on the road to real success. Also, we know the competition does not take a holiday. To quote the great jonny quest... "Get this buck rolling race!"
GLTA!!!
P.S. BIEL. please listen to Jonny!
Good points SteveO. I agree!
GLTA!!!
Yes, you make valid points associated with contraindications cautions, etc. But what should be concerning BIEL is that the technology is being exploited, and marketed by others. IMO, it's only a matter of time, short time at that, before they start to move in on BIEL's target market. Companies like ORTHOCOR have the technology and apparently have cracked the code for FDA clearance. It's quite possible companies like ORTHOCOR don't have the adverse, troubled history with the FDA as BIEL does, which gives them an added advantage with future success with gaining clearance for their product. The point I'm making is BIEL better get their butts in gear and get this thing rolling, Big Time! IMO, BIEL has been really lucky with the wait of opportunity. For in the future, she might not be so tolerant of BIEL, and give others a chance to "Grabbing the Brass Ring". That's my take, for what it's worth!
GLTA!!!
This is interesting! The company OrthoCor has its products cleared by the FDA, and they use the same technology as BIEL. Maybe others on this board have heard of them, but I had not until now. I was reading through one of the Premarket Review documents and noticed this company being used as an equivalent device to Actipatch by the FDA. Hmm! Take a look at their product applied adaptation... BIEL, you better take note!!
https://www.orthocormedical.com/patients/
GLTA, for we are going to need it! Thus, competitors are not only gaining, they are here already!!!
Board question: The SEC has prevented AW from diluting for a while through barring him from stock transactions, right?
GLTA
No, there isn't any disagreement here. Just making another point from another direction.
GLTA!!!
We don't have to "Go To The Dogs" to give a salient example of how BIEL has squandered opportunity for success of the company. One can only consider the Allay product. Years ago, BIEL should have done everything possible to get that product to market. It seems they are slow walking it, just like every other product they own. Thus, consider, there is a larger segment of the world's population, who are experiencing monthly pain issues (i.e., Dysmenorrhea), and there's a product that could possibly remedy this monthly ordeal and it's not made widely available to women, already. IMO, this situation is ridiculous, shameful, and evidence of business malfeasance. Full Stop!!
GLTA!!!
Hey! Google, Microsoft, Amazon, somebody, anybody, please buy us out. Yo! I will gladly let go of BIEL stock for 1 cent! A hostile buyout, ya that's the ticket!
GLTA!!!
Someone posted the following: "I just got off the phone with BIELS, they told me that the financials will be posted tomorrow." That quote was posted on Thursday. Of course, Friday has come and gone, and still no financials. If BIEL, in fact, made that statement regarding financials being posted upon Friday (yesterday), but on the other hand, actually knowing that statement was not true, then shame, shame!
GLTA
If all that's on BIEL's current To Accomplish List fall through, then the results will be scam'mish, even if conscious intent is not there, IMO.
GLTA!!!
Hmm! Oh, Really!!
I think it's a mistake to take the position that this bottomless pit of management missteps and hap hazard business decisions are a by-product of abject incompetence. For BIEL to behave this way incessantly, without abating, thus, it's almost impossible to contemplate this as just clumsiness. IMO, for whatever reason, this is a planned roadmap. IMHO, there ain't no doofus operating the levers here!
GLTA!!!
Apparently, the pattern has been set. IMHO, the FDA has no intention to give clearance for BIEL's products, anytime soon. The ole Ask-For-Additional-Info within about two weeks before the 90 day decision window expires trick, is not new for the FDA. As I recall, during BIEL's previous request for clearance, the FDA pulled the same stunt, before dropping a "Wile E. Coyote" anvil on BIEL's head, so to speak. I dare say, there is a strong chance they will do the same thing this go-round. Maybe BIEL should have given up on the FDA a long time ago. JMO! Not to say that the FDA's recalcitrant behavior is the crux of all BIEL's problems, of course, they are not. Most of BIEL's problems are caused by BIEL, itself!!
GLTA!!!
If one reads about the schemes which this Ali fellow was allegedly involved in, is quite stunning. This guy appears to be a habitual, career criminal. It's unfortunate that the SEC allows people like this to run around for years defrauding people.
Amazing!!
Well, for some people the prospect of making substantial money has the effect of looking through a glass darkly! That will never change, IMHO!!
GLTA!!!
People should just stop making up excuses why the FDA is refusing to approve BIEL's product. IMO, BIEL is being lobbied into the dirt. Unfortunately, BIEL doesn't have the wherewithal to fight back.
GLTA!!!