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Is this company still in business?
Is this company still in business?
The earnings report was disappointing and actually poor.
Despite the Amazon sales rating, Boots, Braun and other seemingly positive outlets....the net loss for the company increased! One would think all these sales would reduce the net loss...however, this is not the case.
There is no FDA OTC ruling coming. 90 days has far elapsed and per the FDA's own rules, they are obligated to provide the company with an update at 100 days since the submission date. Thus, the company has an FDA update, they are just not sharing it with shareholders.
"$NWAV something tells me if First View Financial backs NWAV then they have a retailer on board ready to sign a partnership... "
No true. Remember Praxell? There were supposed to bring riches to NWAV...then they disappeared. They must have saw something they did not like.
"What an ignorance. FDA decision has to come either way for every application."
I know. I think the FDA decision has been made, and has notified BIEL...hence why the stock is selling off on heavy volume. Also, the earnings report was bad...the company is loosing more and more money.
Lol...down 22% after the fluff PR.
This company is a joke and felt the need to issue a PR stating they are having a meeting in a few days.
Now, the stock is down 22%...simple pump and dump.
This company is a joke....
Net Loss Sept. 30, 2015 : (727,349)
Net Loss Sept. 30, 2014 : (723,373)
The company lost more money this quarter, compared to last year. Where are all those sales? I thought Braun was selling lots of these devices?
"FDA is not until March 2016"
LOL...wishful thinking. There is no FDA decision coming.
Financials are out...and they look bad.
Not impressive at all.
Stock selling off on heavy volume. This is not good news for BIEL.
The company is still loosing lots of money.
"Today."
Q3 numbers are due out today? Yikes, massive selling and a 20% ahead of earnings is not a good sign. Bad news must be coming.
"Q1 shaping up to be profitable"
LOL....this is more of a fantasy as opposed to a reality. If Q1 is shaping up to be profitable, then why would management need to increase the authorized share count by 2 billion?
Also, where are the Q3 numbers?
When are Q3 earnings due out?
"That's why 1300 new stores stocking"
Yeah, lots of stocking....but very little buying. Hence the need to generate cash flow through selling shares..... as opposed to selling actual products.
"MMs pull the price down so that they can cover at a lower SP"
A common fallacy is the MMs are the reason for BIEL's low stock price. The reality is BIEL is a 13 year old company who has failed to make a profit.
Despite Boots, Walgreen, Braun and everyone else...BIEL is still a money loosing company. There simply is not enough demand for their products to generate positive revenue. This is far from good.
Also, when are earnings due to be released? Will they provide an update on the much hyped Braun deal?
"The MMs have finished covering their Shorts from Friday.
Time for the ascent to resume."
Wrong. Covering a massive short position helps to lift a stock...because you are buying.
BIEL is dropping, which means selling pressure is high. BIEL is down over 20% on heavy volume....this is not a good sign, especially when earnings are due out soon.
What's going on with BIEL today?
Massive dumping ahead of earnings....this is not looking good. Earnings must be bad.
When will earnings be released?
Heavy dilution today....remember, management has another 2 billion shares to dump.
Last time, management hid FDA news from shareholders....how do you know they are not doing the same thing again?
"Can we expect any PR before market opens?"
A PR about what?
FDA approval was not given, and management knows the reason why. 100 days have passed since the 510k was submitted....it is obvious that BIEL was denied and management has the rejection letter.
Also, where are the earnings report? How many devices has Braun sold?
"SIX MAJOR COMPANIES SELLING BIEL'S PRODUCTS"
Then why can't BIEL break even? Why do they still need to sell stock in order to generate cash flow?
"Finally, the Outstanding Share count as reported on OTC Markets remains unchanged and New Wave has committed to keeping the OS locked through at least EOY 2015."
LOL...this means nothing. The same management team promised no reverse split...then issued a massive reverse split and watched shareholders loose over 90% of their money
"LMAO there is no proof in the post just incorrect information being made up about Biel and FDA. Show proof from the FDA in writing stating the 90 days is up..."
Comon....this is silly. We all know the filing was made on August 6. That is more than 90 days ago...what more proof do you need?
"510(k)'s often take MUCH longer than 90 days. I've seen very few 510(k)'s that got cleared or rejected within 90 days"
So, are you saying the FDA is intentionally posting misleading information on their website? Their website clearly says 90 days....are you saying they are not being truthful?
Friends,
The FDA website is clear....decisions are made within 90 days.
BIEL did not get approval. Because of this, there is a growing belief that the 90 day window is meaningless and this is simply a goal or guideline by the FDA.
The FDA is clear on this, decisions are made in 90 days. Nowhere on the FDA website is the 90 day window said to be a 'goal' or guideline. BIEL did not get approval, its really that simple...and sad.
"The 90 day is simply a goal."
What proof do you have that this is simply a goal? The FDA website clearly states that decisions are made in 90 days, at which time the submitter will be notified of the result.
Because BIEL did not get approval in 90 days, people are making their own interpretation of this being a 'goal'. The FDA does not state this is a goal, they clearly state when decisions will be made.
"The FDA goes by their own rules"
Yes, and the FDA rules are on their website...where is clearly states 90 days. After 90 days, the submitter will be notified of the outcome. Thus, BIEL management has the outcome, they are just not sharing it with shareholders.
"This-CEO was-denied, sat on it, while PR-ing hope! "
The 90 day window has passed......the FDA did not approve. There is no denying this.
"Simple prove the statement in the Post"
Here is the proof...from the FDA's own website, the approval period for 510ks is 90 days. Approval has not been given to BIEL....what more proof do you need?
"A new 510k was filed for the ActiPatch on 8/6/2015...... The FDA has a commitment to process 510ks within a 90 day period. "
From your own post.....the filing was on Aug. 6 and the FDA process period is 90 days. Well, the 90 day window is far closed now...and there is no FDA approval. Approval was not given to BIEL.
"This will be approved this year before Dec 1st and the stock will be $1.25 easy"
Approved by Dec 1st? Stock will be $1.25? It's nice to dream, but the reality is the stock would be trading much higher if there was a hint of FDA OTC approval.
The fact that it is still in the gutter is concrete proof of the lack of faith in any FDA approval and a general lack of faith in this company.
"This will only be a matter of time before the OTC clearance"
BIEL was denied OTC clearance. The FDA rules in 90 days. Management has the rejection letter.
BIEL should be of concern to everyone. Management continues to dilute the stock, which is clear proof that BIEL's revenue is weak. There simply is not enough money coming in to cover operating expenses.
Secondly, BIEL did not get FDA approval. The FDA renders a decision in 90 days and communicates with the submitter reasons for not granting approval. BIEL management has the rejection letter and knows why the FDA rejected their submission.
Interesting.....more dumping after the PR today...classic pump and dump.
Yikes.......more dumping. Shareholders have no hope.
"Folks need to get in SOON. Next leg up coming very quickly IMO"
Soon? What next leg? There is no product and no definite launch date.
"The Nov 6th date was just someone's guess."
This was no guess. The FDA has a 90 day turn around and renders a decision in this timeframe. BIEL failed and did not get FDA approval....its just that simple.
No sir...decisions come in 90 days.
From the FDA website:
"The FDA goal to make a MDUFA Decision for a 510(k) is 90 FDA Days.
When a decision is made, FDA will issue the decision letter to the submitter by email to the email address provided in the 510(k) cover letter."
No decision came in 90 days...therefore, FDA approval was not given to BIEL. This is a rejection.....management has the rejection letter!
BIEL did not get FDA clearance. From the FDA's website, a decision is made in 90 days.
From www.fda.gov: "The FDA goal to make a MDUFA Decision for a 510(k) is 90 FDA Days."
BIEL filed on August 6, thus if approval was given, we would know by November 4. The BIEL CEO has the rejection letter. Folks, look at the FDA website....90 days is the timeframe to make a decision.
BEIL does not have approval, hence the 510(k) was denied, rejected....there is no FDA approval coming.
"ll the hype is about the number of stores -- but why no revenue projections? Why no mention of how many devices Walgreens or B.Braun has bought and has contractually agreed to buy? "
Yeah, where are the revenue projections? Where is actual sales data from Walgreens and Braun?
If BIEL cannot break even, then sales are weak.
"the issue why is it taking so long ????"
It is very likely that FDA rejected this product. A decision is to occur 90 days from the submission date. Take a look at messages, on this board. Numerous, probably most, people expected a decision by November 6. Management also expected a decision within 90 days.
Listen carefully to what management is saying now...they expect a decision by the end of the year. Clearly something is wrong here. What happened to the 90 day timeframe? It is very likely that the FDA already rejected this product and management is now trying to figure out what to do....why else would a 90 days decision be pushed out to the end of the year? The CEO is likely has the rejection letter.