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It would be easier for this company and cheaper in the long run to buy into an established Nasdaq listed play. This alone would be a great way to spin the dx division into that new entity.
In addition, the potential financiers credibility factor would change the current investment dynamics for share valuation. Re, less toxic financing and more true investment. Big difference between financier and investor.
Look for another acquisition and about half of the additional outstanding shares to be used for a revenue generating purchase. This should be done, and finalized within the next month. This will be a good bridge to utilize some current staff which in turn should reduce burn while generating revenue.
Shortly after we will see revenue and also a cash infusion from a partner/spinoff on dx division.
I don't expect that order to be filled and if it does, look out below.
Actually, before I saw that bid I thought we would test day's low again. If this order fills I can see this sub 2 within the next couple trading days.
If this bid holds I think we will stabilize back around 3 going into next week. I am also expecting more news next week to set up more activity leading up to the meeting date. Hope GC pushed the meeting date back to its' current date for a particular announcement/milestone/update reason.
Final thoughts, watch market maker MBAY as he seems to be the one controlling the market lately.
Anyone see the 30,150 share bid at $2.50
Simple, this is a way for financiers and friends to load the boat and or trade before the run.
Been quiet and watching, but thought I would chime in with a quick one.
Penny 101 at its' finest and legalized money shift. Don't get caught up in the sell off hype. You know it is a facet of manipulation.
Hope all is well.
10 bagger automatically once street credit established on NASDAQ.
I agree, and think that is good valuation going into uplist. One would have to think we would be entering uplist at least valued in the .08 SP range with previous funding arrangement at that level. I would also expect those entities to run it up into uplist.
I don't recall exactly, but didn't one of those funding arrangements have provision to free trade if an uplist occurs? I don't have time to verify at the moment, but may be worth a quick overview.
I think share price valuation discussion should be conveyed in market cap valuation. It makes more sense, and is less confusing to general traders on this forum. Then after transfer occurs share valuation will be easily calculated. I think many people are hung up on share price and less on market cap, which as you know is basis for SP. Likely due to lack of knowledge, but that is fine because everyone can learn.
Point being, I think transfer to NASDAQ increases our total valuation firmly to $150 million alone. Once diagnostic division spinoff is announced we should see an additional $150 million valuation. Both combined should value holding company in excess of $300 million.
So in short term, our share valuation should be 3 times its current value once up list occurs and 6 times current value after diagnostic spinoff.
Any additional positive news will only add to market cap value. Investment ownership will be the wildcard once we get up listed. Should see a lot of interest finally payoff from these investment conferences. Great timing, IMO.
Everyone will want to own a piece of action with so many wild cards in our deck.
Low, would like your dark side master thoughts on AMBS. Specifically with odd news of late and timing of today's RS filing. Been some major chip action on the funding front lately too, and at a much higher price. This just seems odd and I would like your opinion.
TIA
AMBS broke out slightly yesterday and confirmed today. There has been a lot of financing deals of late that should confirm the movement up now that everyone is locked and loaded.
Low, AMBS alert again. If you don't already have it on watch, put it there.
This post and reasoning makes absolutely no sense. Please explain...
Thanks in advance.
I second that JP. ICON wants this to be the biggest blockbuster diagnostic of all time, just as much as AMBS. Now that Georgetown agreement has been inked, this board announced, I don't see too many more pieces left to put together. AMBS is clearly dotting all their i's to build a solid foundation before commercialization over takes an undeveloped structure.
This stock has so many people following it that when the dark side (as Lowtrade would say) lets this go it will free trade. Someone obviously wants to accumulate more shares before it is released. It may even happen with a non event.
Just a matter of days until LymPro generates revenue. That announcement can come tomorrow, next week or next month. People on sidelines waiting for that announcement will have to pay up on the uptick causing even greater explosion.
There seems to be an extreme amount of confidence for revenue generation in my opinion. Why else would a company extend itself for three large purchases? Trust those insiders on this one, or sit on your hands and watch. Either way, exciting days ahead.
I don't expect any large cash infusion until after the LymPro spinoff. I think once that is done we will hear about how that division will be monetized and money will flow into holding company. It has been mentioned several times that it is the intent of AMBS to have such a structure for its' pipeline to transition, so for them to not establish LymPro spinoff into stand alone diagnostic division first seems unrealistic. This also gives them an opportunity to redirect more shares for management. I
Well said. I would add this. If Amarantus is able to purchase two companies at once, eradicate pending litigation between the two parties, and still buy them for a discount, we have gained a profit on paper. Therefore, dilution is not bad if value is gained in return.
Low, some big form 4 chip action on AMBS in after hours. Please look at the form 4 filings and share your thoughts.
Also, had another company acquisition announced this week. This is the second purchase in matter of months.
Would love to get your opinion of action since this is still trading on OTC. These things just don't seem normal on OTC.
Thanks in advance,
AMBS chart alert again.
"The numbers for Lympro have essentially never changed in 12 + years."
Hello, that is the point and proof of stable results.
AMBS huge volume open. Low, is .095 your next resistance point and then free trade zone?
AMBS back to breakout point. Larger volume yesterday may give this the momentum for breakout. Chart is set to run, let's see if it does it this time.
This has had lots of great news for biotech stock over the last two days and you know how quick biotech stock can move.
Amarantus Receives Orphan Drug Designation for MANF in Retinitis Pigmentosa http://bionapcfa.blogspot.com/2014/12/amarantus-receives-orphan-drug.html?m=1
Low, how would you evaluate this one with the latest FDA approval news and the news of first Alzheimer's blood test launched for use in clinical trials.
On a couple occasions Gerald has mentioned Lympro as spin off diagnostic. I expect that to be the cash infusion needed. The question should become, how or which way will he spin it off?
One other thing to watch for is the number of active market makers. Once this starts the next move you will see several MM's on level 2 trading this for a swing. They will also start accumulation and manipulation on the way up. Just a heads up!
This PR is what I have been waiting to see. It is not the content specifically, but the re-announcement of news already known. This is a sign that the PR campaign has begun. I now expect a continuous flow of announcements over the next two weeks.
One thing I expect will happen is announcement of first Lympro sale/contract...As stated in this PR it is expected to happen in 2014. This means revenue coming in and an offset of burn rate.
Unlike others, I don't think we will get large spinoff agreement or license deal up front initially, but if we do then all the better. Just setting my expectations a little lower as we introduce this into the market. I think the longer we hold out on license deal the more people would be willing to pay.
We shall know soon.
I am in New Orleans at an offshore workboat convention, which you would think is ideal for sat phone side of ops, but don't see any representation. If in LA, then he is not here
AMBS alert again Low. I would appreciate your opinion on latest acquisition announcement, funding arrangement, and if you have time opine on dark side action for spinoffs in OTC land.
This one seems to be full of either potential or major manipulation with dark side potential in the near future. Don't forget they granted another billion shares recently!
Thanks in advance
The better news is big pharma will likely be the one dictating which test will be commercialized initially. With near certainty one would think AMBS will be meeting with those pharma's to ask them which test they would like to use. This almost is conviction on getting test introduced into their screening. Which means sales pipeline immediately!
At that time I would think many pharma's will be asking price of individual test and price for LymPro as a stand alone sale. They may even be taking orders now based on commercialization launch window. Marketing/sales works in many ways!
Gerald and team wants this to happen soon and I think they are pushing everything they can to make big announcement before the end of the year. As it was stated, he has bonuses tied to key elements of performance.
The most interesting part I find about tomorrow's conference call is the timing. For one, it was released today for a the call tomorrow. Secondly it is for 8:00 AM, which is before the market opens. Typically they like to do their conference calls after hours or in the late afternoon since Gerald is on the West Coast. Since it is urgent and before the market opens one would think there is good news to be released. It surely doesn't leave much time to digest before the market will open.
I guess speculation won't matter much because in less than 22 hours we will know more on this quickly planned call.
Low, AMBS back on your watch list yet? An updated chart analysis would be great.
Thanks sir.
If anyone was wondering about Orphan Drug application stats look here:
http://www.accessdata.fda.gov/FDATrack/track?program=osmp&id=OSMP-OOPD-Percentage-orphan-drug-designation-reviewed-completed-in-90-days-or-less
I disagree and think that his resignation would cause more of a plummet and share price. It would also be a sign of instability within management. When on the brink of success I think we want little change and continued focus forward with the current people in place. A management change would only cause more delay.
It is buy time for many. This is where we pick up a new wave of flippers who watch for bottom bouncing picks.
Looking for a strong move up over the next two weeks to gap fill up to $.12 with Gerald starting a new wave of pr supports. I think he has to begin a new or campaign at these levels and we should see it begin by mid day today.
All my opinion. We shall see.
Prove it...
Before you begin discrediting anyone you should understand what you are posting. Your referenced concern is only for medical devices as indicated in 21 C.F.R. 820. This code does not apply to AMBS for its' LymPro Blood Test. In the situation of AMBS we do not create, manufacture, package, etc any medical 'devise.' It would only apply to the 'devise' used to extract the blood from the patient...not us, sir.
You need to look up and read the C.F.R. before you continue discrediting AMBS and yourself of any further dribble.
Here is just the introductory of the code. If this doesn't do it for you continue reading the definitions section which would immediately follow the Scope. I would presume you can find the appropriate link to continue your own reading.
§ 820.1 Scope.
(a) Applicability.
(1) Current good manufacturing practice (CGMP) requirements are set forth in this quality system regulation. The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. The requirements in this part are intended to ensure that finished devices will be safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act (the act). This part establishes basic requirements applicable to manufacturers of finished medical devices. If a manufacturer engages in only some operations subject to the requirements in this part, and not in others, that manufacturer need only comply with those requirements applicable to the operations in which it is engaged. With respect to class I devices, design controls apply only to those devices listed in § 820.30(a)(2). This regulation does not apply to manufacturers of components or parts of finished devices, but such manufacturers are encouraged to use appropriate provisions of this regulation as guidance. Manufacturers of human blood and blood components are not subject to this part, but are subject to part 606 of this chapter. Manufacturers of human cells, tissues, and cellular and tissue-based products (HCT/Ps), as defined in § 1271.3(d) of this chapter, that are medical devices (subject to premarket review or notification, or exempt from notification, under an application submitted under the device provisions of the act or under a biological product license application under section 351 of the Public Health Service Act) are subject to this part and are also subject to the donor-eligibility procedures set forth in part 1271 subpart C of this chapter and applicable current good tissue practice procedures in part 1271 subpart D of this chapter. In the event of a conflict between applicable regulations in part 1271 and in other parts of this chapter, the regulation specifically applicable to the device in question shall supersede the more general.
(2) The provisions of this part shall be applicable to any finished device as defined in this part, intended for human use, that is manufactured, imported, or offered for import in any State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico.
(3) In this regulation the term “where appropriate” is used several times. When a requirement is qualified by “where appropriate,” it is deemed to be “appropriate” unless the manufacturer can document justification otherwise. A requirement is “appropriate” if nonimplementation could reasonably be expected to result in the product not meeting its specified requirements or the manufacturer not being able to carry out any necessary corrective action.
(b) The quality system regulation in this part supplements regulations in other parts of this chapter except where explicitly stated otherwise. In the event of a conflict between applicable regulations in this part and in other parts of this chapter, the regulations specifically applicable to the device in question shall supersede any other generally applicable requirements.
(c) Authority. Part 820 is established and issued under authority of sections 501, 502, 510, 513, 514, 515, 518, 519, 520, 522, 701, 704, 801, 803 of the act (21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, 383). The failure to comply with any applicable provision in this part renders a device adulterated under section 501(h) of the act. Such a device, as well as any person responsible for the failure to comply, is subject to regulatory action.
(d) Foreign manufacturers. If a manufacturer who offers devices for import into the United States refuses to permit or allow the completion of a Food and Drug Administration (FDA) inspection of the foreign facility for the purpose of determining compliance with this part, it shall appear for purposes of section 801(a) of the act, that the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, or servicing of any devices produced at such facility that are offered for import into the United States do not conform to the requirements of section 520(f) of the act and this part and that the devices manufactured at that facility are adulterated under section 501(h) of the act.
(e) Exemptions or variances.
(1) Any person who wishes to petition for an exemption or variance from any device quality system requirement is subject to the requirements of section 520(f)(2) of the act. Petitions for an exemption or variance shall be submitted according to the procedures set forth in § 10.30 of this chapter, the FDA's administrative procedures. Guidance is available from the Food and Drug Administration, Center for Devices and Radiological Health, Division of Small Manufacturers, International and Consumer Assistance, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002, 1-800-638-2041 or 301-796-7100, FAX: 301-847-8149.
(2) FDA may initiate and grant a variance from any device quality system requirement when the agency determines that such variance is in the best interest of the public health. Such variance will remain in effect only so long as there remains a public health need for the device and the device would not likely be made sufficiently available without the variance.
[61 FR 52654, Oct. 7, 1996, as amended at 65 FR 17136, Mar. 31, 2000; 65 FR 66636, Nov. 7, 2000; 69 FR 29829, May 25, 2005; 72 FR 17399, Apr. 9, 2007; 75 FR 20915, Apr. 22, 2010]
Giddy up! We should see a world wide pr campaign launched soon. This will cause major explosion as no pr campaign has been launched on AMBS yet.
Revenue posted in 4th Q will be welcoming. Should start to see steady trend up beginning today. Go $AMBS
Good concern, but not applicable in my opinion. As you can see this code section of the Code of Federal Regulations refers to "medical devices."
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 812 INVESTIGATIONAL DEVICE EXEMPTIONS
At $.20 we are still only at $150 million market cap. Lympro alone would bring that in multiples if sold to a pharma and MANF would likely bring as much as Lympro as it sits.
What a great opportunity for many. Once an up list occurs people will begin to see the true value and interest of large institutional investors. That will be a great day!!!
Here are my shorthand notes...
ICON has converted over 40 times from BD to ICON
Cost less than $150k
No revenue until 2015 on LymPro and will be from research in AD
RUO segmented market - $150 mill annually
Position - Aid in a diagnosis to AD
Pre-Screening patients before going into AD treatments
On average 50% patients screened with PET fail - large cost $10k per patient screen
30-40% savings per PET screen means we are looking at about 6-7k per test total
Contracted research company - 200 ongoing AD Trials - 143 Phase 2 trial (focus) estimate 100 subjects per trial 14,300 potential subjects.
Sales via clia will be modest in 2015, but 2016 will be growth with pharma partners
44 subjects tested to date
Expanding study to include early stage AD - can identify all stage. Currently in late to mid stage.
RD increased over 700k to 1.2 million due to clinical work
Anticipate increased an increase due to key product programs.
Has cash and cash equivalents 2.4 million
Additional 18million equity financing through LPC
List AMBS on exchange on later in the year
Eltroprazine - No drugs approved for Lid
Charlotte Keywood - clinical
drug project manufacturing
clinical study protocol
clinical research organization
Open IND in Europe
To open IND with neurology with FDA
Start trial at end of this year
MANF
Want to get into clinical trials ASAP
Moved aggressively to take IP and Licenses
Will continue this strategy on Licensing and IP
Develop in orphan indications and retain ability to advance for curative application
Done private toxicology in the eye and was great success
Potential diabetes application
Protein therapy is focus at the time
Preparing MANF to FDA for one or more orphan optomal indications.
Q&A
Jason Napodano - Zachs
Data from AAIC and C4CT Summit - accuracy of those results and adding biomarkers. What biomarkers are we looking at and what is the return of those biomarkers.
Answer: CD69 subsurface marker - All other markers are all cell types and express CD69
Pharma's think 80% is really good especially from a single marker, because additional markers can be reviewed. Each marker added on complicated the analysis to a certain extent. Have to add another antibody to identify cell type and another to identify CD69. So each additional marker required additional antibody. Each antibody added increases cost and does change reimbursement. Exploring different combinations of the markers to come up with a matrix with efficiency, effectiveness, and cost control with maximum profit margin.
Could be several 1000 of these tests processed a day. Could cut a 4000 person trial group to 2500 to identify 2000 accurate AD patients for PET. $15 million on enrollment alone on this example.
LymPro - "stage independent" demonstration that score will not be different for each stage of disease.
Commissioning of first of several work orders only $150k or less. This will get LymPro ready for presentation to pharma companies doing clinical trials.
CLIA requires only 1 lab for use. This is going to be a long-term relationship with ICON. Part of the sales price will go to ICON for doing the work because they will be processing test.
CLIA to validate the assay. Put ourself into other business arrangements but will not discuss on this call.
ELTROPRAZINE in discussions with an individual Dr. XXX who has worked on this. Discussed him being the principle investigator. First POC trial was 50% funded by MJFF. There has been some additional discussion on this forthcoming trial. Will occur with or without MJFF. They are interested in more quantitative data. Looking at true connecting monitor devices, stream of high density data. Concern of accuracy of patient diaries. Want to get better or true quantitative measures of this data. Looking into potential grant applications.
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Quarter by quarter view of next quarters
Enrollment of EL2 - expect to see full data
Requesting meeting with FDA on ELTROPRAZINE
MANF - see additional data on toxicology work
4th quarter
efficacy of MANF
file one or more apps with FDA
LymPro - receive completion of study
Expect to see completion of fit for purpose and clia
pre-ind meeting and filing and initian of phase 2b
2015
Initial commercial sales on LymPro
trials LymPro will be used in
FDA response on MANF apps
Commercial manufacturer of MANF - target list done now and doing due diligence on now
Toxicology data on MANF
ELTROPRAZINE - end of phase 2b
LymPro continued use in clinical trials
Marketing effort initiated
Not sure of spinoff
Looking at a number of strategic transactions - asset acquisition, offsetting expenses from various transactions
Tiered approach to LymPro sales
Want to be involved in as many trial as possible but theraputic successfully trials. If they become successful by use in their treatment they would have to use LymPro in identifying test. Want to be a companion diagnostic.
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J. Petro, JWP Inc.
Need shares available to protect negative market forces in hostile takeover. Key focus.
As we look to expand the company into strategic acquisition for opening new lines of business and fortify current lines of business. Investors want to know they are not investing in dead horse.
There is a potential to raise additional capital and want to have the ability to do that in the least dilutive method as possible. Where/who you raise money is important.
Have seen other companies on OTC survive by diluting out shareholders, don't want to follow that trend. Want to see true value by increased for him and his family, and shows his true intent.
Not many billion or 5 billion $ companies on OTC marketplace.
Want to allow larger institutions to take large value accredit positions into the company.
AMBS does not have the intent to go it alone, want to maximize every dollar in to AMBS to max amount to shareholders. Big pharma has invested 10's of billions into AD research without any credence into verifying trials.
Want to follow Amivid footsteps. LymPro is leverage point in negotiation to acquire exclusive asset. Groups in big pharma want to see more data and are very interested in ICON data.
Phenogard - prohibited discussing partnership activity, but can say they are active. Astrocytes have taken on importance in scientific community. Have 87 Cell lines in freezer. Trying to expand on different cell lines and high degree of confidence that we are going into other proteins. Can't go any further on those results.
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Have met all milestones - CRO has been terminated for lack of enrollment measures and was reason for delay in the data.
Expect to grab a large number of the $150 million potential revenue. Need to determine how many markers will be part of assay.
I apologize if there are any inaccuracies as this was quick shorthand as I heard it.