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The assembly of the electronics and everything is done overseas in Asia. What they do in Frederick is simple manual operations of packaging etc. Actipatch is a simple device to manufacture.
Just going off a little experience - in order to make one million actipatches a month, you need to do about 50 parts a minute on a 2-shift working day, no weekends. This is really moving. At this point you would have more than one machine for sure but I am just putting some estimates to it.
New equipment lead time for something like this is 6-12 months, that includes qualifying the process. Just one machine that does everything including packaging and to run at 50 parts a minute (if it could be done reliably) is over a million USD.
Of course, this only considers a water faucet scenario where you go from nothing to max right away. That is not accurate as a ramp up to a million a month is just that - a ramp up.
But look at us talking about manufacturing capacity...Fun to think of these things because by the time they buy equipment like this our pps is a heck of a lot higher than it is now.
This topic is just fun to speculate. Manufacturing capacity will never be the bottle neck with BIEL. I have met Bill Monn a couple of times over the years at trade shows etc. I don't think he is a regular down there anymore but he was in charge of these topics.
Not true. I saw their manufacturing area and yes with millions purchased in one quarter they won't have the capacity if they sit and do absolutely nothing. With the money made from all of those actipathes they buy automated production machinery. This is what I do for a living.
Nice try ;)
I wonder what these three orders are for that they mention on the financials? It says depending on international clearance but I would guess that means FDA clearance. Maybe NHS roll out or Mundi or Bayer. All three? Someone else? Exciting times again after a lull there for a few months. Truly happy we held the ship after financials. If you want BIEL cheap always wait until after financials. Except for when it’s too late. If fda approves this quarter, which they should, these orders will leave the dust behind. Yes we are down in sales over last year but KN is about long term and good deals for the company. This company and profitable is a serious contender in the market.
Trade the company and not the stock. Keith is here and stuff is getting done. Holding for many more years.
Just like the opioid challenge when we heard it was happening this VA info came out of left field. Only time I even heard of those two letters and BIEL was Steve - nice work! This to me says the US govt has now officially recognized this healing potential as legitimate and beneficial to veterans. It’s just like when we got the new category in feb 2017. It’s a long road. Maybe ten more years but these are the selling years. Keith has his $$$$ together. Keeping holding until you see the whites of big pharma’s eyes!!!
Hey Steve
Loved this interview. I wonder why it wasn’t louder to the masses but I stopped trying to understand that long ago. Maybe KN is more important than FDA? He is methodical and isn’t wasting any time. It makes me think that us on this board are having fun speculating but we are very very far from their daily activities. Keith just proved there is a lot of daily activity.
Patience in BIEL = $$$$$$$$$
Fictional? Using hard data of current approval lead times is hardly fictional. You are concerned with your followers. I am concerned with realistic current views
Very nicely summarized. I think Christmas is the target for approval. Some talk on here about taking profits etc and to each their own. I understand the very many years of frustration. I thought I could be rich by now but I also spent many many years down 80%. Didn’t sell, just forgot about BIEL on purpose. Then in feb 2017 I knew this would work. The FDA finally created a new category and we were added. Now it’s just the many years of new applications etc. I am very long on this stock. It’s been ten years and it could be ten more for true realization. Of course lots of profits along that journey. Good luck.
I will make a side bet that we won’t hear anything until it is approved and the people will be irate then they will forget all about it!
Art
This is exactly how I feel. When I saw them it’s a small office shared by others in a larger building without an 18 wheeler shipping dock. But when I left I wanted to know if I invested in a powder keg of gunpowder. The answer was “yes” I did. It has been and will be tough sledding but buys at 0.0017 are something you will look back at as complete steals.
What trap? I listened to the FDA’s webinar on this topic. I guess you are happy being entered in to this competition. I am happy winning the competition. We don’t know the winners until after the new year. Be careful with your wording to us true longs. We have all done our own detailed DD and are not as susceptible to rumors.
Maybe this will work:
BIEL is not confirmed to be in discussions with JnJ. The FDA challenge says the participants are chosen in Nov not winners selected. Winner selected is maybe January. MM’s are playing and this is a very slippery slope. Go Keith!
BIEL!
The drug more powerful than fentanyl that was cleared this past week is getting noticed by larger and larger news feeds.
https://fox8.com/2018/11/04/fda-approves-new-opioid-more-powerful-than-fentanyl/amp/
I hope this story blows up in the FDA’s face and to save their backsides they clear us and use BIEL as the new method.
Read this one. It will anger the blood. I wonder what “holistic” approaches there are out there?
https://www.washingtonpost.com/amphtml/national/health-science/fda-approves-a-powerful-new-opioid/2018/11/02/88cd27e6-deaf-11e8-85df-7a6b4d25cfbb_story.html?noredirect=on
Unbelievable Viking. Just read about it’s characteristics. It’s from AcelRX Pharma which is only a $300MUSD market cap company. I read a news story and the FDA commissioner says don’t worry it’s a very controlled single dose used only in health care environments etc. makes you wonder. First developed by Janssen which is now under J&J back in the 70s. I am normally calm and patient but this is truly a WTF
I tell myself that the organized and methodical sales approach started when KN was hired. Everything before then doesn’t count. It’s the tale of two companies. I do think they are setting themselves up but they never divulge their hand to the public. Only make assumptions on things that actually happened, not speculation. For example, hiring a Dir of Reg Affairs. That really happened and we speculate why.
Yes - Bayer was auditing the quality control process. I was there Friday June 8. They were visibly frustrated and kind of scoffed at how long and arduous the process is to get up and running. I tried asking Paul the state of the process but did not get an answer and I am not surprised.
Thanks Art. I will probably leave it where it is anyway. I use E-Trade and can move it there and trade if I wanted. I really have enough shares of BIEL. I mentioned the 401k money to support how ridiculously low the stock price is now for what I think the potential can be.
I wish we could get more info from BIEL but the only way I found to do this is to get an appt and drive there. Feasible for me but not most.
My two cents on FDA timing
Even when I went there Sree told me about the meeting, it was mostly mathematicians and statistician talk. AW and KN are quiet while the tech guys talk FDA speak. The result of the meeting, as I understand, was you’re good to go and we advise you that you file like this. Read the PR statement for more details.
I have been here long enough to know nothing is easy and it takes much longer than expected. I don’t care about the 90 day or 100 day stuff. BIEL won’t tell us at 100 days anyway. We will have to wait for an uptick interview. Go from the current avg time for any approval which is 180 days.
So I hope for clearance by Christmas as a present to us.
I did get bad news, my 401k acct mgr says I can’t sell holdings and buy BIEL. They said it’s a penny stock and too risky. Of course they would say that but you would have seen millions of shares at 22. These prices
Are ridiculous
I was reading that today - all of the different product codes and what they mean. If you read the feb 2017 clearance it starts as you are off to the races then the page comes for knee and foot. PQY means all over the body.
Sree’s words: full body clearance gives us a “hunting license” to go after whatever they want.
It’s all exciting but you still need patience.
He is in his 70s. My hope is Sree and KN take over. Don’t know who would be acting CEO. Sree is very young and talented and Keith has plenty of years ahead to grow this company. All assuming they are not bought. I don’t think his daughter would move to Frederick and get involved directly on a daily basis.
This is a great post JN.
I never thought seriously about buyouts until recently. Reason being is there is a huge task ahead to get even close to making this a household name. I am behind the tech 1,000% but I find it hard to believe if/when BB or Bayer come in to business with BIEL that they won't try and buy the whole thing. It would not be much capital at all for them. $500M seems reasonable but I think true street value is higher than that, but who else will think that? Will hedge funds think that? Will AW still even own BIEL if they make it to the DAX or NYSE?
I still have a lot of patience left for BIEL, but I also started getting in to BIEL when I was in my mid-20's. I feel for the investors at or in retirement waiting for this to be realized. I have a FDA approval sell order set to above a penny but for only about 4% of the shares I am holding.
I was very happy to see them hire a Dir of Regulatory Affairs to be located in Frederick. AW wouldn't do that unless he knew he needed the bandwidth and help. In the past, AW navigated all of that stuff. KN's job is to sell sell sell and SK's job is to promote the tech, develop new studies and handle FDA filings etc.
I am not an expert on the share structure but that has always been a looming question on what will happen to us. If I cash out up 400% on the year after approval I will be disappointed. I think true long value could be as high as $3-5 BUSD. I keep reading balance sheets of mid-cap Healthcare companies with $3B market value and no profitability. But they also have hundreds of employees. BIEL has around 7 (that are not in production filling boxes).
I have also been here a very long time. It’s great to see this effort but for the impatient - a buyout is the fastest way to getting rich and leaving. Problem is that will never happen until AW is satisfied with his vision of what this is worth. It will be tough for an office of a few people to magically become a $5B monster without a lot of outside help. I hope Bayer has great sales with the product and NHS. We know it works and they know it works but will their customers buy it? If they do they try and buy AW. I don’t know what he would do. I do know that he won’t do it without the buyer overpaying him. He has a huge chip on his shoulder after all these years. I am frustrated at the lack of communication but it’s always been this way. That’s why I drive there to know. I would take a buy out if the number was several B’s. I am sure he knows his number but he is getting up there in age. But I will say again, AW is just a tough guy. He doesn’t let people roll over him, ever.
Very strong buy right here.
Have a good evening
DB
Very good DD. The difference with this meeting in May was the mathematical statistician part was present representing BIEL. KN and AW told me that to my face. They were quiet, the numbers guys and tech guys talked. I really think it’s a formality to clear it so that will happen whenever it does. BIEL is finally set up. It’s a real fun ride but I always remember I was down over half my investment for many many years but I always believed the tech. I bought heavy in trips. Go BIEL
Pretty lofty expectations, don't you think?
1) Clearance? - possible and I read your reasoning in an earlier post
2) False - maybe you are playing with words. Yes, the participants are formally announced but we won't know if we won until 2019. Winning is the only thing that matters not news that they are accepted in Nov.
3) We really have no idea but it's possible
4) False - even AW said next year
I agree with your optimism but my opinion is the expectations on these opportunities need to be pulled down to Earth.
100% av. I triggered my first sell at FDA approval just because I told myself I would many years ago. It’s not a high price and it is a very small fraction of my shares. I hope to give shares to my young daughter in the future. Being in a micro penny stock with a long future is a rare occurrence. I swear it’s best to forget you own BIEL on a daily basis. Check back in monthly. Wish I had the discipline
South side
Long here. In my experience you see the pop for a few days then give it a week or two weeks and the people that are just hearing about BIEL bc of the pop are the ones that back out. Then the price goes down by maybe half. It will trickle down further unless we hear news on sales or some big win with Bayer or CVS or Braun whoever. That will keep it up. The unknown is timing. So for me I am not buying any more shares. I have enough and there are three zeroes on my avg price. If you want to spend money do it now. Don’t wait for a more expensive price. But that’s the risk, if no FDA then you waste your money. My bet is on all this stuff really happens. Hope this helps. Just an opinion
Nice shot of optimism. BIEL can really get to ya can’t it? They are two different entities - BIEL the stock price and BIEL the company and technological potential. Pipeline has never been more full and if they can survive so many years of nothing then we can survive a couple more to let sales be realized.
Study - 24,000 cleared devices from 1/1/06 to 12/31/13. What was the average time it took? 6 months. Radiology devices are the fastest but not much faster and dental seems to be slow. Takes about 5 months for the application to formally clear.
Lots of talk on this board about the 60 day period and the 90 day target. Those are only guidelines. The data shown on this link is much closer to reality IMO.
The talk of $0.18 by Christmas is a pipe dream. Not saying it won't happen but certainly not by Christmas...2018. I think we get approval by Christmas and the stock price at the end of the year is around a penny.
Link to study -
insert-text-here
The sales opps in the pipeline are exciting but they won't hit until Christmas as well. As a long, I am thinking I am in this a few more years. However when I am out, I do expect the price to be a few shiny gray coins per share.
I agree Art. I am happy to say I never stepped out on the sidelines once. I think it still is a great buy but I have enough shares and will not be buying any more. I wish the FDA was somewhat linear - meaning you could make sense of why something is approved after we turned in the application. We do share similar thoughts on where we think the ceiling is for this company. Best of luck to you and selling any time before news is a huge mistake. IMO
Never said it before but worthy of a sticky. Very well put. If you are new and need a summary, read this.
Nice work and good thinking BielDog! Do you ever look in the mirror and pinch yourself? And recheck to make sure you got a ton of BIEL stock?!
A huge game of dominoes is building. All you need is one flick. Full body gets it and winning the fda challenge secures it.
Art
We talked about this in our meeting together. I always loved the semicon sales model for a tech like this. Andy seemed to like the idea but he is far from that industry and I am far from the consumer med industry. Dr scholls is what I am describing, that kind of business. Was in rite aid today looking at the DS insert - plenty of room for our perfectly placed device. Right on the heal.
All of these finds are great and are exciting to see but please remember that this was only a small test by BIEL. Putting product on the shelf is challenging but the only thing that matters is getting people to take them off the shelf. They won’t put them on CVS shelves for good until much advertising is done to go with it. This was confirmed through their official PR rep. However...CVS! That’s impressive. Patiently waiting...
Blatch
Confirmed. I received the same email from Paul. I called him this morning.
I uploaded a pic of the new package that shows all three applications for when broad clearance occurs. I see about the reason why it is on shelves now. I didn’t know how you put in on shelves if the generic consumer bought the heel device which is cleared for plantar fasciitis but they don’t have that. Set me straight. Wouldn’t a dr need to prescribe? I am stronger on the tech side and not the regulations side.
Help me out DB.
How can they do this without clearance? Does it only need to be pending? If so, how does CVS know what the FDA is doing? Someone might have already answered. This is great but in retail the trick is how do you get people to take the product off the shelf not on. Keith’s words not mine...
Wow. Anyone that brings up J.N. Is a true long. What a train wreck those years were...I wonder what that guy is up to now? Proof is the only thing that matters and sales is proof. And proof means we are...$$$$$$
It’s just a difference in opinion, it doesn’t really matter. The only thing that matters is the fda did not ask for anything, Bayer will be next year, Mundi is moving and we might have a USA partner. That’s what I got out of it. It only took 14 mins out of my day so if it was Kermit the frog saying it I wouldn’t care.
Simps
High respect for you on this board over the years but why are you so hard on AW? Yes, KN is a better speaker but he just got there and AW has been at this for many years. I completely understand why he would want to deliver the interview. It’s his baby not Keith’s. To say he holding his employees back I think is a little harsh. AW works every Saturday so how do we know this wasn’t done on a Saturday when the office is quiet. Shouldn’t KN be doing the heavy lifting anyway and not have time for an intercoeee.