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Percentage gains and losses are cosmetic at this level but the fact the price is this low is far from cosmetic
A follow up is are the chips on order or have they physically been obtained and in the warehouse. Putting an order in does not prevent back orders and having the chips unavailable.
Read it a few days ago and was surprised when another Whelan questioned why are you explaining this to anyone. Kelly responded and I was actually impressed that Kelly did and shows that she does consider the stockholders that BIEL is not just a blank check for her
Has the buying opportunity changed since 2012, it is when I got in, 10 years waiting for the opportunity potential to finally break. These legs are tired of treading water but would rather not drown in a loss or break even
A 50% increase from0.0003 to0.0006 is not as significant as .03 to 0.06
Careful the definition of insanity is doing the same thing over and over and expecting a different outcome. I have been purchasing for years waiting to hit copper but can not keep throwing money at a wish. No where near a 100 million owned but enough that when I looked at my overall investment in BIEL I was surprised. Hoping that change comes soon but personally going to hold my current stock amount until results are shown.
Did we ever find out what happened to it being on the shelves in the US?
Have to agree that until the stock price moves up and stays consistent deals that the company does not announce mean nothing. Guess I am finally getting tired of waiting for the tsunami, the biel hurricane storm, the volcanoes eruption of Mr bielsuvius and the biel train getting ready to leave. Over 10 years investor who bought at the dips for years just would like something for loyalty
Seriously? The stock is still triple 0’s. Stock price increase means nothing at these low prices.
If you are going to make such unrealistic accusation please at least have proof or data.
Going way back into the musical archives for that one!
Actually that was a positive and true post. BIEL does not have to worry about the SEC crackdown since they are compliant. Which means they are not a shell corporation. Another positive is how many hundred types of pain relief are sold on Amazon to be consistently in top 90 for weeks shows sales are steady
Or the company realize fluff interviews and news releases detracts from substantial news when released
Just waiting for the big miracle for the stock price to rise from the dead!
Besides the deals being signed late in 2020, placement in stores and advertisements started mid through first quarter. Hope to see improvement from quarter to quarter from here on out!
If it was only one trade no significance but look at the the number of trades today of 10k and less. MM are still game playing. I have been long since 2011. Patiently waiting, may not have 100 million shares but have a few. In the Pharma industry and understand the CE mark issues and FDA submissions and significance.
With a one share trade this morning of a sub penny stock, I am not as optimistic as I was yesterday
BIDEL might be struggling, but that BIEL investment is looking like a winner
The whole purpose of OEM partnerships I believe was to have the partner handle the advertisement costs.
Geejay
Well stated, social media is good for quick gains but long established growth requires sustained sales which management is putting in place! Love the direction and feel from the company. Been here since 2013 and questioned the investment on more than 1 occasion but So grateful I did not loose faith.
Pharma Companies do make a killing but necessarily on vaccines, more about volume. The BARDA contracts has the price predetermined so not much profit. J&J is providing almost at cost.
Welcome to the Big Leagues!!! would be awesome if that means a promotion from Minor League to Major League or in other non baseball words Pink Sheets to Nasdaq.
100 million? Sorry not everyone’s pockets are as deep to take a chance. Though I am comfortable with my stake, do I wish I had more sure. But unfortunately two kids in college and have been patiently waiting since 2012. Personally hardto justify more of a stake with the limited peaks over the last years though this does finally feel like the company is turning the corner.
I would think so, like the fact that replacements are being offered. Wonder the split on the 40?
The website has a replacement loop for just under $40!
And if Biel gets the MDSAP certification, major countries US,Brazil, Australia, Canada, EU and I think Japan will be covered by one inspection and certification by a notified body audit. Governments are harmonizing medical devices.
It is not an inferior product, the FDA allows for the two different types of submissions. It is FDA cleared. They can not say FDA approved in packaging that is a legal fact but it does not mean it is an inferior product. The data in the submission has to be substantially better than a previously approved FDA product. The FDA has to come to the the conclusion that is it substantially better. The FDA DOES NOT give clearance or approval for innovation alone Or to snake oil, gizmos or junk. Biel’s submission meet the requirements of the 510k it was a faster clearance to market. The clearance will allow for partnerships and so on. So long story short clearance can be and is a good thing.
That is just the filing cost. PMAs require more clinical data and can easily approach 100 million from development through submission
Just stating the difference between 510K and PMAs. An area I deal with, never made a claim one is better for sales so take a deep breath just pointing out the difference why one might cost 2.5 k and the other 90k application fee from a regulatory standpoint. 510k is also used to demonstrate substantial equivalent to a predicate device. This is most likely the reason Biel went the 510k route plus a 90 day review period compared to a 180 day period
A 510k clearance does not legally allow a device to be called FDA approved it is only cleared. A PMA requires clinical trials and legally can be said to be FDA approved. Huge difference between the two and the reason for the price differential. The differences can be found everywhere with a little due diligence.
What ever happened to Orel Hersheir the MLB pitcher? He was posting about it once.
FDA does get behind, there were 48 months at my place for our medical device product. Just stating what I know from 30 years in industry. The big piece to take from the update is no comments or finding on the quality systems. It shows that BIEL has done some maturing. That is a huge positive. Not sure if people understand what quality system means....Supplier and vendor audits, specification, costumer complaint handling, CAPAs and NCRs, pharmacovigilence, manufacturing and release procedures, test procedures, sampling procedures, etc, etc. FDA goes over all of this and more even reporting structure, quality can not report directly to operations. This is a good step forward. Not sure it ties in with approval, approval might have reminded FDA they were behind in routine audit of company. It is an important step.
I did read the last sentence. It is a routine GMP inspection. They occur every 18-36 months for any medical device sold in the US. I am long on this stock and await but saying the FDA inspection is directly tied to a possible approval while the company already has approved product can be misleading.
FDA was a routine GMP inspection that occur every two years. Although the product might have been discussed, it was not the main focus of the inspection. What is important that the company had no 483’s or other findings and the inspection lasted only two days is another good sign that compliance and quality arebeing properly addressed. Having experience with FDA, sounded like an exceptional audit.
The TGA grants approval for Australia, similar to FDA. CE mark has no affect for the Aussie.
FDA inspects all medical device plants for product to be sold in the USA
I believe Medical Devices in Australia require TGA approval.
Existing in its present form since 1985, the CE marking indicates that the manufacturer or importer claims compliance with the relevant EU legislation applicable to a product, regardless of the place of manufacture. CE marking is mandatory for certain product groups within the European Economic Area (EEA; the 28 member states of the EU plus EFTA countries Iceland, Norway and Liechtenstein) plus Switzerland and Turkey. The manufacturer of products made within the EEA and the importer of goods made in other countries must ensure that CE-marked goods conform to standards.
As of 2019, CE marking was not required by countries of the Central European Free Trade Agreement (CEFTA), but members Albania, North Macedonia, Serbia, and Montenegro had applied for membership of the European Union, and were adopting many of its standards within their legislation.
CE marks are required only for European Countries. Australia does not require it.