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"LMAO then there is nothing to do but assume the post is false, it's the only thing relevant when you state it as facts"
I am stating the facts. Per the FDA website, the FDA must communicate the status of 510k applications at 100 days after the submission date. Thus, the FDA has communicated with BIEL....BIEL just hasn't shared the update with shareholders.
"WRONG ERBB asked who? not how many days or any of the other Bull, just a simple question who contacted Andy."
This is an irrelevant question, as the exact person who communicates with Andy is unknown. The fact is the FDA has been in contact with BIEL and explained why their 510k application as not been approved. This is a fact and no disputing this. The FDA is required to do so.
"Don't understand. Who contacted Andy.
False information"
Actually this is not false, and is true. At 100 days after the 510k submission, the FDA is obligated to inform the submitter the reasons why approval was not granted in the 90 day window. If the there was a delay, the FDA must provide an estimate when the decision will be made. The FDA must contact the submitter and tell them the reasons why their 510k has not been approved. Check the FDA's own website for confirmation, if you dont believe me.
In any event, BIEL management knows the reasons why approval has not been granted....they are just not telling shareholders.
"Biel's Strong Success Independent of US Market "
LOL...we are definitely seeing a change in sentiment toward the FDA. More and more people are now claiming the FDA 510k decision is of less importance as BIEL really doesn't need the FDA, nor the US market.
A month ago, the FDA 510k decision was believed to be guaranteed. Now as time passes, it is becoming more and more evident that BIEL's 510k will not be approved, or has already been rejected. So now folks are claiming that the FDA 510k is of little importance.
Also, take note of BIEL's stock price....we are seeing a gradual downward slide. Guess the FDA OTC approval is not coming after all....
"seems like a hard time per post accepting that world class companies and some of the worlds largest healthcare companies are selling Biel's products geeeeeez"
Yes, but the constant and frequent need to dilute the stock, to fund day to day operations, is clear indication that demand is weak....BIEL the 13 years old company who cannot break even.
Well, another day has passed....and no word from BIEL as to why the FDA did not grant OTC permission.
Remember, the FDA was obligated to inform BIEL the reasons for not reaching a decision, or for the rejection. Either way, the FDA has communicated with BIEL on the status of the 510k application...BIEL knows the truth, they are just keeping this from shareholders....why?
Wow, did you folks see the NWAV Twitter page?
Last week, SchoolFuel was being positioned to be with 1000+ retailers....now the card may end up with 4000 retailers. That's a big jump inside of a week. What will happen next week.....10,000 retailers?
Amazing success for a card that does not exist, of which no launch date has been provided.
"$NWAV .0015 x .0017 quiet day thanksgiving is coming and then NWAV sees pennyland before Christmas."
How will NWAV see pennyland? They dont have any products, no revenue, no sales...nothing. Also, they dont have a launch date for the card.
The only way to see pennyland is to have another massive reverse split, which they have done before.
"If FDA does not reach a MDUFA decision within 100 FDA days (i.e., 10 days after the MDUFA goal), FDA will issue a Missed MDUFA Communication, which is written feedback to the submitter to be discussed in a meeting or teleconference, including the major outstanding review topic areas or other reasons that are preventing FDA from reaching a final decision, with an estimated date of completion. "
BIEL management knows the reason for the rejection, or for the lack of approval.
BIEL management knows...they are just not telling you.
"We keep hearing the same things yet the price keeps rising!! "
Look at a chart friend.....the stock is down over 90% from its high.
Yes, there was a bounce....but the overall stock performance is poor.
"Ask of .0014 now.. 2 mm's bidding at .0012.. maybe we'll break .0015 and run today with some momo.."
Or maybe BIEL will trade lower...which is happening now.
"Biel will exponentially grow in 2016, with or without FDA clearance"
Yup, there is definitely a change in sentiment toward the FDA. As more times passes, folks are coming to the realization that BIEL is not going to get OTC clearance by the FDA.
Statements like this, which claim the FDA OTC clearance does not matter.....are becoming more and more common. It seems like folks are trying to convince themselves that BIEL does not need FDA clearance. These are the same folks who claimed that FDA clearance was a certainty.
"Today. We. RISE."
I disagree. Management typically takes the opportunity to further dilute the stock with each spike in price.
Look for heavy volume today, a a drop in price, as management looks to dump more shares.
"dont care about FDA"
There is definitely a change in sentiment regarding the FDA. It was once believed that the FDA would make a decision on BIEL's OTC status within 90 days and this message board was overfilled with joy at the prospect of soon to be riches.
When 90 days passed with no decision, the sentiment changed again to that of the FDA decision really not having much impact on BIEL as their global outreach was large.
Is seems with each passing day, the realization is setting in that BIEL is not going to receive OTC clearance by the FDA, and people are trying to convince themselves that this really does not matter.
"Yeah because they "ONLY" have 1200+% Store Growth "
LOL...this is comical. Over the years, BIEL has announced many distribution agreements which give their products significant more presence. This really means nothing....without demand, they will not be selling many products.
"Once approved for OTC distribution, BIEL will have the money it needs to begin a nationwide advertising campaign. That will increase demand. Hard to do any true advertising now with such limited resources. Make no mistake, it's coming.
"
Where will BIEL get the money for such a massive advertising campaign? They will have to issue and dump more shares.....
"your post makes no sense. you ask why no updateon the meeting and then proceed to ask if its pump... yeah,,its pump with no uppdates "
Sir, please take the time to comprehend what I included in my post. The 'pump' was issuing a PR announcing a meeting days in advance.
The fact that there was no update after the much hyped meeting only serves to prove the PR was simply a pump.
Is this company officially out of business? When will the stock be delisted?
What's the deal with NWAV? They put a PR announcing an upcoming meeting with FirstView...the meeting has happened, and now there is silence.
When is the launch d?ate? Or this PR simply another attempt to pump the stock?
Remember, BIEL has announced literally dozens of partnerships and distribution deals over the years.
BIEL's problem is not a lack of product visibility, it is a lack of demand. Sales are weak, because demand is weak. Despite high rankings on Amazon and with Boots, BIEL still cannot break even.....because people are simply not buying enough.
The FDA OTC decision is a mystery, at best. Remember, at 100 days (after the submission date) the FDA is obligated to inform the submitter the reason for a lack of decision, or the reason for a rejection. In the case of a delay, the FDA must provide a revised estimate of when the decision will by made.
Thus, the FDA as told BIEL the reasons why FDA status has not be granted. If the reason was a simple delay, then BIEL would have a revised estimated date as to when the decision will be made.
BIEL knows the current situation with the FDA......they are just sitting on this information and not telling shareholders.
Also, remember they increased the authorized share count by 2 billion....that means they have 2 billion more shares to dump. If there was any hint of making a profit, or breaking even....then there would be no need to increase the share count by such a significant amount.
" If demand is good online, they said that's when they will start to carry it in stores on shelves. "
The main word is 'if'......'if' demand is good. BIEL is a decade old company that never had good demand, hence the need for management to continuously dump shares. Demand has never been good, hence the reason why BIEL has never broken even.
"Product is selling in several countries and revenue is not generating much even though product review is good"
You have identified the key problem with this company......sales are weak. There just is not sufficient demand for their products. Management needs to sell shares in order to generate cash flow needed to pay basic operating costs.
This is a 13 year old company who has yet to break even. This is a very sad state of affairs.
NWAV is a joke. Management felt the need to issue a PR, days in advance, about an upcoming meeting.
Now, days have passed since the meeting took place...and no news, nothing.
Also, what's the latest on this partner who will get SchoolFuel into 1000+ stores? Are investors to believe a yet to be released product, with an unknown launch date, backed my management that has a track record for failure....will be in 1000+ stores?
"Provide Proof."
Please look at the FDa website. The FDA makes 510k decisions within 90 days. If a decision was not made within 90 days (after the submission date), or if there was a rejection....the FDA is obligated to communicate this with BIEL at 100 days.
Thus, FDA has told BIEL management the reason for no decision, or has told BIEL management the reason for the rejection....BIEL management chooses to keep this from shareholders.
"$NWAV SchoolFuel meeting with @FirstViewFN starting......now!"
Whay happened to this all important meeting yesterday? What was the outcome?
"Tomorrow should be a pretty good day with news like this IMO. "
Why? The news came out before the bell today....and the stock did not move. Despite the seemingly good news, BIEL finished the day unchanged.
Also, what is the deal with Braun? How many products have they sold?
"GEEEZ only up 250% plus from .0004's"
Let's look at the complete picture. The stock is still down 99% from it's high.
"Could hit .01 easily imo.
Many good news coming!!! "
Good news? Friend, they dont have a product....hence no revenue and no money.
Management is simply pumping the stock, planting visions of 1000+ stores adapting their card, talking about the major partners they may have....management is all fluff now. All this fluff is meaningless without an actual product.
Has management provided an actual product launch date....no.
"The CEO is sitting on the rejection now, which will only make matters worse for him. "
In my opinion, this is the case. From the FDA website, the FDA is obligated to provide information on a 510k application at 100 days after the submission date. We are well past 100 days, thus the FDA has told BIEL management the reason for a lack of a decision or the reason for the rejection.
BIEL management knows the situation with the 510k....they know why a decision has yet to be made....they are just not telling shareholders. Remember, they have another 2 billion shares to dump, thus it is in their best interest to keep any bad news a secret.
"... the formula and how Biel with 1700+ stores is going to do $7.5 million in sales in 2016..."
Please enlighten us, how many devices has Braun sold? You frequently mention how large Braun is......how many BIEL devices have they sold?
I have yet to see any BIEL products on Braun's website. Can you also enlighten us as to why Braun is deliberately keeping these products off of their website.
"I really Need to see a 0.003 by this Friday... "
No way this thing is going higher.
They have no product, no sales, no revenue.
They have an endless string of broken promises, but you can't make money off of this.
"Watch that LOCOMOTIVE named BIEL, speeding through at 250mph"
Locomotive? BIEL's net loss increased! What happened to all those sales on Amazon, from Boots, from Braun?
With all these sales, how could the net loss widen?
Per the FDA's website....at 100 days after the submission, the FDA is obligated to inform BIEL of the current status of their application.
If no decision has been made, the FDA is obligated to explain the reasons. If there is a delay, the FDA is obligated to provide a estimate of the decision date.
Bottom line, BIEL knows the current situation with the FDA...they are making a decision to hide this from shareholders.
"WHERE DOES IT SAY"
From the FDA website :
"The FDA goal to make a MDUFA Decision for a 510(k) is 90 FDA Days. FDA Days are calculated as the number of calendar days between the date the 510(k) was received and the date of a MDUFA decision"
"If FDA does not reach a MDUFA decision within 100 FDA days (i.e., 10 days after the MDUFA goal), FDA will issue a Missed MDUFA Communication, which is written feedback to the submitter to be discussed in a meeting or teleconference, including the major outstanding review topic areas or other reasons that are preventing FDA from reaching a final decision...."
Folks, 100 days have passed.....the FDA has communicated with BIEL as to why approval was not given. BIEL knows the reason why...BIEL knows the current situation....BIEL has been informed! If there was a simple delay, I think BIEL would have told shareholders...the fact that they are sitting on this information indicates something is not good. BIEL knows why the FDA did not reach a decision!!!
"$NWAV how about 1000+ retailers in one fell swoop for SchoolFuel! Stay tuned.... Entering discussions w partner that could do just that"
LOL....is this comedy hour? This yet to be released product, with an unknown release date, has the potential to be used in 1000+ retailers?
If you believe this, then I have a bridge to sell you.
"Praxell will be embaressed if the truth can be revealed "
Embarrassed? How so? Praxell was touted as an all important ally...then they just disappeared. Don't you find this strange?
"Still? It's never BEEN in business."
LOL.....what was the reason for exiting the cannabis business? I thought they had in demand products?
"Where does it say that the fda is obligated to tell the company after 100 days? "
Check the FDA's website.....all the timelines pertaining to 510k approval is there.
So what's the upcoming or latest promo? Reentering the cannabis space, another fuel product....what's the new gimmick?
"There is no obligation or responsibility on the part of BIEL to share an FDA update with anyone. "
Interesting. BIEL doesn't have to share an FDA update with anyone? It is very sad that you have this belief, especially when BIEL's management essentially promised shareholders that FDA approval is coming.
By the FDA's own guidelines, they would have communicated with BIEL about the status of their application. BIEL knows the current situation and the reason why is has yet to be approved. If the reason was a simple delay, then I am sure they would eagerly have shared this information with shareholders. There is something going on here and it is sad that shareholders are being kept in the dark.