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I guess the writing is on the wall. The FDA isn't planning to clear anything further that BIEL presents to it!! What went wrong?
GLTA!!!
This makes no sense, why didn't BIEL just leverage advertising with debt, in order to drum up business? Yes, make some money! If you have a winning product, that seems to me that would be the route to take, instead of diluting like a mad hatter. Diluting is another way to drive ones company in to the ground. If the CEO is that incompetent, then maybe he should be placed in another capacity within the company. This is a very odd situation!
GLTA!!!
Oh my! This thing is dropping like a rock!!
How Sad!! Please don't say it aunt Anna Mae, I bought another "Pig in a poke". Unbelievable!!
GLTA!!!
People please stop blaming the FDA, MMs, heck, let's include the man in the Moon, if that will make you feel better. The reality is the buck stops with BIEL's CEO and overall top management. That's it! Ok, let's consider that the FDA is the stick-in the-mud (i.e., the prime obstacle), in regards to BIEL not getting it's deserved position in the U.S. medical device market. Well, IMO, one should attack that situation by putting the FDA on the defensive. Yes, put the FDA on "blast", as some might say. Get the word out that the FDA is denying the American public serious medical treatment. That's what this comes down to, precluding applied medical care for people who sincerely need it. That's just one line of strategy to employ to confront this situation. To be sure, there are other methods to consider. My Goodness! If BIEL's management can't figure this out, then they need to pack-up and go home, so to speak. This is ridiculous folks!!
GLTA!!!
The ramification of losing FDA clearance is enormous! Think about it!
GLTA!!!
You can't "Poo Poo" not getting FDA approval!
GLTA!!!
If it doesn't happen by tomorrow, who's to say it will happen at all. The fix maybe in! The Big Boys Play Rough! Hey! If it's 90 days, or 100 days, when you consider the power of the FDA, it doesn't matter. They can always say no! They can always come up with a plausible excuse not to grant clearance. Who can stop them from doing whatever they want to do? If it doesn't happen by tomorrow, it's a very bad sign, indeed!
GLTA!!!
Very good points DB. But what I was get at, in general, was that BIEL would relieve a lot of anxiety if they would just keep the shareholder informed regarding the companies consequential activities. We don't need to know everything little thing that goes on there, so-to-speak. But matters of major company transactional developments, well, I think they should keep us posted. I don't think that's too much to ask. JMHO!!!
GLTA!!!
Well, you're right "it is what it is". But what it's not is no communication by BIEL to shareholders.
GLTA!!!
If nothing happens by Fri. DB, then what? There is a chance of that, don't you think?
GLTA!!!
Two days to go before the 90 day deadline. If it doesn't happen by then, it will be interesting to hear what the accommodating excuse will be. Hey! What about another 90 day countdown, that's the ticket! LOL!
GLTA!!!
Has anybody reviewed the latest BarChart projections? Wow!
Just what does that mean????????
https://www.barchart.com/stocks/quotes/BIEL/opinion
GLTA!!! My Goodness!!
What! Do you think BIEL can go on like this for an extended amount of time (e.g., another year or two), without funds to speak of, lagging sells, no advertising and stay in business?
Please Be For Real!
If BIEL starts to heavily dilute again, shareholders will start to bail! IMHO!!
GLTA!!!
I think I've seen this before, but nonetheless, it's only a notification of registration.
GLTA!!!
Well, it would be kinda suspicious if the FDA denied BIEL clearance, particularly, if considered their granting clearance for two of BIEL's products in the past.
GLTA!!
Don't count your clearances before they are granted! I've been involved with stock associated sure-things before. Want to know what I learned from those experiences? Nothing is a sure-thing!! Hey! I hope nothing but the best for BIEL regarding this situation. Thus, I'm hoping nothing but the best for myself and the rest of the shareholders. But Just Being Objective!
GLTA!!!
I made a similar point in one of my earlier posts, and was kinda rhetorically cuffed for it. But, IMO, if the month of Nov. turns out to be a snub of BIEL, then maybe all BIEL shareholders will have a momentous decision to make. No Doubt!
GLTA!!!
Well, if it can be proved that their dawdling is unreasonably, and their intractability is effecting BIEL by a greater degree, than other clearance candidates, then BIEL should have a case. The point I'm attempting to make is if the FDA's actions are proved damaging to BIEL in a prohibitive manner, IMO, that would be an easy case to make.
GLTA!!!
Does anybody know if the FDA has ever been sued? Even though they are a unique govmt agency, they still should be in the realm of "sue-a-bility". Yeah, that's not a word but please allow it, in this case.
GLTA!!!
Someone said on this board that if the FDA reaches 100 days and the Actipatch is not approved, then the FDA must issue a letter to BIEL explaining why they have not approved it yet. It was also said that it should be expected that Biel will inform shareholders soon after receiving the dreaded FDA's letter of "non"! But I would sadly disagree with part of the aforementioned scenario. Thus, IMO, BIEL has so much disrespect for it's shareholders, it's conceivable that they wouldn't say one word to the shareholders about that hypothetical letter. To Reiterate, JMHO!
GLTA!!!
Well, what I mean is, it would be devastating to BIEL if the FDA refuses to grant any clearance, at all, next month. I agree, if at least one of the major clearances, which BIEL is seeking gets granted, then that would be an existential occurrence. But if nothing happens in Nov., then it will be a "Bad Moon" on the rise for BIEL. If Nov. turns out to be a nothing burger month, then it will be really rough for BIEL going forward. FACT!! IMO, BIEL won't be able to survive many more lack luster financial quarters as it has in recent history. It appears that the FDA is begrudging BIEL clearance, for what reason, well we can all speculate. But they have the power, and they are using it. Let's just hope they eventually do the right thing by BIEL. That's my take!
GLTA!!!
This situation with the FDA is reaching the level of imminent concern. Some on this board seem to think BIEL has all the time in the world to get things rolling here. They don't! IMO, they don't have another year to diddle around and further dilute. This time next year, if things don't change, they could be out of business. JMHO!!
GLTA!!!
If the FDA doesn't do right by BIEL during the month of Nov., then what? Hmm! Well, maybe we BIEL shareholders will have to make some unpleasant determinations! It will be scary times!
GLTA!!!
I assume, there are other organizations within the NHS network which have recommended prescribing for the device? Is that assumption not correct? If my assumption is correct, then why are they an outlier?
GLTA!!!
Just disregard the NHS Affiliate Lancashire Med Mngt Group info I presented. I think they are just full of "IT", if you know what mean!!
GLTA!!!
I performed a search on the Buckinghamshire online database and found nothing referring to Actipatch. If anybody has anything different, please reveal it!
GLTA!!!
What you are citing is search slotting, not denoting the presence of a database data item.
Note the updated NHS Affiliate - Lancashire Med Mngt Group web page; it has the following:
Actipatch — Treatment of pain in knee osteoarthritis, plantar fasciitis and sub-muscular breast surgery.
Maybe this is old news, but nonetheless, the link is listed below:
http://www.lancsmmg.nhs.uk/news/october-2018-updates-website/
GLTA!!!
Didn't find it!!
"There’s one CVS near Chicago that’s now showing Actipatch in stock." Do you realize how pathetic that revelation is? My Goodness!
GLTA
I hope you know if what you stated is true, corporate malfeasance is the only term for their actions!
GLTA!!!
Here is the exact date the Big Bang will happen, Nov. 31st, 2018! That's It! It's a Wrap! Shh! That should keep'em buying!
GLTA!!!
That wasn't an "Opportunity lost...", that was an Opportunity not wanted. How many times should I state the following?
This whole thing is orchestrated by BIEL's brain trust. IMO, this is an overall strategy to dampen the sell of their product(s). Why they are doing this, your guess is as good as mine. Obviously, BIEL has some very smart, accomplished, people positioned in its organization. They are not dummies! They know exactly what they are doing. Thus, for me, the conspicuous question would be why are they doing this.
GLTA!!!
Ok! Thanks, for the great feedback! I saw that DB provided that info regarding FDA Full Clearance day-by-day countdown reset. DB, is it possible for you to point inquiring minds to the source of your information on this? Thus, just who inside BIEL provided this data? Thanks!
GLTA!!!
As I recall, shortly after the 510K submittal, BIEL's CEO stated that he expected the FDA clearance to come in 90 days, or sooner(that might be a quote, not sure). So, maybe the CEO should be called on his prediction. Maybe he should get an inquiring email asking... what went wrong? Is there anybody on this board who has, at their disposal, inside contact cred which would eventuate the aforementioned? If so, let's do it and wait for a very interesting response. We, as shareholders, have a right to know what's going on here, wouldn't you say?
GLTA!!!
P.S. We shouldn't have to resort to Facebook for information. We should be getting it from the source. Oh! So dysfunctional!!
Just who are the "MM's"? Is it BIEL who is the de facto MM in this case? They are the ones who are keeping all this great news to themselves. Don't know why but it's apparently true. I wouldn't ultimately blame other entities for any of this. Let the chips fall where they objectively should, and call it a day. That's about all an on-looker can do in this case, don't cha think?
That's My Take!
GLTA!!!
This is impressive news! Why BIEL won't "piggyback" such news to enhance its public relations footprint is beyond me. They are prosecuting this business model of anonymity for an objective reason, I would think, but why? Hey! BIEL, we shareholders are your partners, so how about letting us in on the grand strategy, we won't tell.
GLTA!!!
Investors have a right not just privilege, to ask any questions of a company in which they have invested. Especially, if that company has a tendency, history, of neglect regarding its responsibility to inform it's shareholders. Fact! It's plausible to think BIEL could have made decent money promoting its earlier FDA approved product(s), if the appropriate business strategy had been implemented. But management choice not to do so, why? If this is a display of sheer, unadulterated incompetence, then we all are in deep trouble! Not Good!
GLTA!!!
It's not the FDA that's delaying this thing! IMO! Thus, logic would suggest that the problem why BIEL hasn't gotten clearance at this point resides at 4539 Metropolitan Ct. Now, there might be a legitimate reason why BIEL is operating this way. I'm like most of you on this board, thus, I haven't faintest idea regarding what is going on behind BIEL's closed doors. But what I do know, for sure, BIEL does not inform it's shareholders at a standard which one would expect, IMHO.
GLTA!!!
I think it's just a waste of time to even entertain any notion that anything good will become of this situation concerning REVO/Eyetalk360. I have all but put this lost cause to bed!
GLTA!!!
Who is offering 1 cent? Would that be Eyetalk360?