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True...but it sounds like the dialogue back and forth has been very good ...leading up to the IND filing (based on what the CEO said..if you can believe him).
This week is very important...we need to stop the bleeding and have some positive and meaningful PR's (if nothing is wrong and the fundamentals are strong...than state the case).
Also, its time to put a stake in the ground; Gerald needs to schedule the Year end conference call and create a positive backdrop to build confidence (which is something he really has been lacking as a CEO).
10k & Eltoprazine IND:
1) Do we know when the 10-k filing dealing is exactly? I am thinking by 3/31.
Also, the Eltoprazine IND was filed on 2/23; If I am correct; I believe the FDA is mandated to respond within 30 days (so Mgt. should know where Eltoprazine stands by 3/23 ..or a few days later).
Lastly, I thought the shares issued over the last few months had a 6 month ..no selling stipulation. So I would think that their are a ton of shares outstanding; but they are not converted.
Thoughts-?
JP: Perhaps this is our problem..what exactly has this guy delivered in terms of sponsored research? Gerald needs to bring in people who can perform. Cavendish....a mirage too?
F. Randall Grimes
Head of Sponsored Research
F. Randall Grimes
Mr. F. Randall Grimes has more than 20 years of marketing, business development, financial and R&D leadership experience in early stage life science companies. He founded The Randall Group in 2001 to help small to medium-sized technology companies raise funds using state and federal competitive grants. He has garnered over $25 million in non-dilutive capital for clients and employers, including more than $1.5 million for LymPro Test development. Mr. Grimes has previously served as the Vice President of Technology Development at Provista Diagnostics, Inc., Vice President of Operations at RCP Diagnostics, Biomarker Technologies LLC and GW Medical Technologies LLC. Mr. Grimes has authored eight issued patents and has published articles in major technical and trade journals. He holds a B.S from University of Arizona in Material Sciences and Engineering and M.B.A from University of Michigan Business School with an emphasis in new product development and operations management.
JP:
I understand your frustration and I agree that Management had no right to acquire expensive assets at this time. And it looks like LymPro's true upside is still unknown (yet to be determined since its not CLIA certified nor FDA approved either); so they need assets that can produce revenue down the road.
I need to hear whats going on with the ESS govt. funding and the MSPrecise tax credit conversion...still holding out hope there (reminder - see below).
"ESS is currently being developed with support from a grant from the Armed Forces Institute for Regenerative Medicine (AFIRM). The AFIRM grant was awarded to support the IND and initial clinical studies. Upon execution of its option, Amarantus anticipates initiating a10 patient, Phase 1/2a clinical study, evaluating the efficacy of ESS vs. meshed split thickness autograft (AG) in the second quarter of 2015"
"On November 10, 2014 DioGenix was awarded a $7.45 million 'Grow New Jersey Assistance Tax Credit' ("Grow NJ Tax Credit") from the State of New Jersey to facilitate the establishment of a laboratory in Camden, New Jersey. By statute, Diogenix can sell the Grow NJ Tax Credit in whole or in part for a minimum of 75 percent of its face value, subject to certain conditions. Amarantus intends to immediately evaluate the sale of these tax credits".
Stay strong....taking a few steps back to take many steps forward.
Brean Capital Maintains Buy On Progenics Amid Positive Phase 2 Data For PSMA ADC In Pre Chemo Prostate Cancer
February 27, 2015 12:19 PM EDT by Jason Cohen, Editor in Exclusively Published • Healthcare • Insights
Well, he seemed to like the results; its a great validation and vote of confidence. Its not a full blow win here; but the therapy still has some strong potential in the right treatment groups. Also, Management was just issued Non qualified stock options on 3/2 and reported on form 4's on 3/4 (some sizeable share amounts). AZEDRA long term study results are good as well (Fast track status as well). I say..the stock grinds higher going forward.
In a research note released today, Brean Capital analyst Jonathan Aschoff reiterated a Buy rating on Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX) with an $11 price target, after the company released the presentation of the full results from its Phase 2 clinical study of PSMA ADC in patients with metastatic castration-resistant prostate cancer (mCRPC).
Aschoff stated, “PSMA ADC elicited meaningful tumor responses, CTC improvements, and PSA reductions in both post-chemo and pre-chemo prostate cancer patients who failed Zytiga and/or Xtandi, with results being more robust in pre-chemo patients. Also, patients with high levels of PSMA expression and low levels of neuroendocrine responded better to PSMA ADC. Progenics identified 2.3mg/kg as the optimal dose given its better tolerability.”
Furthermore, “We believe positive Phase 2 results are robust enough to attract the attention of a partner to conduct a Phase 3 trial with PSMA ADC for pre-chemo mCRPC. The Phase 2 trial enrolled a total of 119 mCRPC patients who failed Zytiga and/or Xtandi, including 84 post-chemo and 35 pre-chemo patients, and we note that in addition to the efficacy, safety in chemo-naïve patients was the most favorable we have seen yet with PSMA ADC.”
So JP: why do you think so many smart and talented people would risk their careers to join this company?
Although we really dont know what level of success remains and what the future holds; I just dont think all of these talented people would join if the ship was going down.
Stay strong....the company still has many valuable assets that can be sold under a worst case scenario...I am not happy with what has transpired with the stock price either..
Note: I believe LymPro study results will be presented at a Alzheimers conference around March 18-22nd timeframe...perhaps we will really know where LymPro stands and whats going on with the different biomarkers by that time frame.
The Eltoprazine IND filing is moving us one step closer to an uplisting. If the mgt. team can get the ESS asset up an running...than boom its time to do the Diagnostics spin off and Uplist.
In our journey, we are at one of the most pivotal transition periods of the company's history. Remember...any non dilutive funding could easily double or triple the company market cap in very short order. GLTA!!
Great point! This is the untold story that many many wont see coming; HALO is getting ever so closer to profitability. The PEG20 can be the huge swing vote ..on any expedited FDA approval.
I love De-risked bio's....HALO seems to be one of the best out there.
Hey JP...we are all in this together....glad to see you actively posting here once again. Risk ...is one of the good guys...does great due diligence and has a good grasp on connecting the dots. You seem to have the beat of the Street...we collectively can help and compliment each other on the way to prosperity.
Let the good times roll my friend!
Higher Volume always precedes price movement...if this new incremental volume (without news) sustains itself.......I strongly believe the "in the know" crowd is accumulating ahead of very meaningful news.
Lets see how the PPS performs tomorrow. :)
Check out those P-values on Slide 43 on the Biotech Showcase presentation ..(posted on the company website). Also, the upcoming LymPro milestones include initial Pharmaceutical (biomarker) customer sales too (slide 48..see below).
Slide info:
Key Takeaways
? Only diagnostic blood test in the marketplace for cell cycle dysregulation to
support pharmaceutical therapeutic development programs: biomarker services
? Clinical data published in 2 peer-reviewed journals, and internally confirmed
? Distribution channel to support US/EU clinical trials at Icon Central Labs
? Initial target market: ~$150M IUO market for pharma trials
? Total commercial market opportunity: ~$3B
Upcoming Milestones
• First pharmaceutical biomarker customer sales
• CLIA Certification
• CE Mark
• FDA pathway evaluation
Avanir is having success with the LID drug (company just got acquired by Otsuka). But just know their is competition out there in the LID market (just keeping things straight here).
Also, AMBS is presenting the LymPro data at the Biotech Showcase Conference(and not at the JPM Morgan conference).
Quote:
Mark my words… and those of Warren Buffett (from a Motley Fool investor article)":
Of course, a “wall of worry” is nothing new. The old saying goes that the market climbs a wall of worry. Today’s wall has a light covering of moss… yes, it’s a little slippery. But over time, it will continue its inexorable and inevitable rise. Mark my words.
AMBS is ready to run....the stock has based for a while (which sets the stage for a breakout). If Warren Buffet can suggest to buy stocks when their is a lot too worry about.....I agree and think that AMBS management will overcome any worries too.
What an exciting time to be a shareholder. Actually, the two upcoming conference presentations are going to have a much different feel and affect than in the past...
1) as the Eltoprazine launch is most likely imminent. What to watch for is if they got any non dilutive funding for the trial (a MJFF sponsorship or anyone else will double the stock price).
2) Secondly, the latest LymPro data release could have a significant impact; if they were able to increase the specificity and sensitivity back above 90%. Any Pre-announced revenue will light a fire under the stock price too.
3) Thirdly, there are promised near term catalysts coming as to what other Diagnostic assets were acquired and what potential spin out can occur with LymPro as well (and if there are any hints on timing of the Up list).
4) MANF - what is next? I think their will be a surprise factor here...so many possible (3rd parties) could be attracted to this asset. We have not heard much about the Parkinsons program either.
Amarantus has grown up; but is it capable of taking a leap and catapulting its credibility (with delivering the goods). Historically, I cant imagine a more critical time and juncture in the company's history than what could happen this week. Its showtime folks!!! GLTA!!!
How far did it tank versus where it was earlier in the week/ AMBS went down with the market correction; and back up it comes as the market rallies...waiting for all of the great news coming....stay thirsty my friends.
Its not Hedgies; but Market makers playing the good old fashion manipulation game (ahead of great news along the way). Stay long and strong!!!!
GS1:
Thanks for keeping the board real and reporting FACTUAL information.
They are on the OTC (no institutional support to drive the pps higher)....so the conclusion you have drawn is useless. Secondly, their was significant tax loss selling through the end of 2014...you might want to be truthful and share that information in your determination of ultimate failure regarding the pop in the PPS (due to ODD designation).
Why dont you contact NanSomix management and confirm whether they will peer review the data? Did they earn any revenues yet? Since you are a believer in the NanSomix product over LymPro; get some real factual information thats based on meaningful Science that is published in journals (if its so great and wonderful).
I will continue to align my investment decisions to how Amarantus management provides support and guidance going forward. Btw: What exactly are your credentials that anyone should respect or listen to you? I think you have an ego that you need to stroke for some apparent reason' and enjoy providing subjective feedback (versus giving objective feedback which really works best).
Please be careful to draw any conclusions as to how NanoSomix's product has beaten LymPro to the market. The test appears to be very one dimensional as it relates to identifying p-tau as a biomarker (solely). Secondly, Amarantus has aligned with some heavy hitters (Becton and ICON); so these collaborations provide excellent sponsorship that Pharmaceuticals will heed notice to as well. Lastly, I am wondering if NanSomix will peer review the data; as Amarantus has clearly stated they will be doing so in 2015.
Note: Lets see how Jobo spins the NanSomix article into a disaster for Amarantus....always fascinated to constantly hear the negative in everything AMBS produces or executes within their pipeline.
Excerpt from NanoSomiX article:
“Our first blood assay will be available this fall for researchers and pharmaceutical companies that want to use p-tau as a biomarker for drug evaluation or patient sample enrichment in their clinical trials,” said John Osth, President and CEO of NanoSomiX.
You really need to stick to posting the facts. The company does not have 1.3 billions shares issued, converted and outstanding. Hence, we dont know exactly how many shares (issued recently) are going to be converted 5/6 months from now.
If management can find non dilutive financing to offset the trial costs; the future share conversion (for many of those shares) wont be necessary.
I will patiently wait for Management to inform us shareholders of material news, major drug or product announcements, Up listing progress and other key important updates.
To hear all of this mindless speculation from a message board poster is really a worthless exercise.
Do your own due diligence and have faith in Management and their respective execution. They didnt hire bright people to be second guessed by message board posters (as some here who think everything is wrong with the company yet these are the same people posting more than anybody else here).
Simply, they want your shares; so the spin doubt as much as possible. I would rather invest my time finding good companies that align to my investment thesis (AMBS will be a HUGE winner...we are so close to having it proven in many ways).
Happy New Year - 2015!
GLTA!! GO AMBS!!
Maxim Group conversation:
I spoke to an Analyst at one of the leading investment boutique firms in NYC (who covers small bio's). He routinely speaks to Gerald from time to time; he reminded me that the ESS trial start up has unique attributes because its not a drug compound that carries a lot of risk. Most importantly, he said once the trial starts up; the market cap alone should be increased by at least $150-$180mm (and Wall street will heed notice once the firm is Up listed).
Overall, the incremental dilution (more recent) is minor in relation to the quality assets that Gerald (and management) have been acquiring lately and of whats most important is the true underlying valuation (so watch what happens to the Market cap in 2015....you will be pleasantly surprised).
Note: Sorry Solantey; you last chance to acquire the PPS much cheaper are behind you. Just recognize that you cant stop a tidal wave that's starting to begin and in motion; just jump on and go for the ride.
I got my sell orders in at my broker come Monday. Thanks for enlightening all of us to reality.
Go AMBS! See you are still looking back in the rearview mirror.
Talented management, incredible Science and touted in many Scientific journals, strong relationship with KOL's and what do you eventually get...great news with a stock price that will eventually move north......because you cant keep a good thing down for too long.
Hey, you did get one thing right ..it sorta based in the high $.07 and low $.08 area for awhile (at least you are good for something).
Happy Holidays!!!
No worries! There are plenty of other great companies out for you to discover and investigate; it would be wise for you to just take the leap of faith and due some due diligence to find the right that fits your world.
Most importantly, the retail crowd rarely ever gets it right; as the patience gets worn thin through a long development phase cycle. January will be the month that AMBS will turn a VERY significant corner (I haven't sold a single share since acquiring a hefty stake that keeps increasing...lets talk in a several weeks and compare notes).
Insiders are buying below $.08 (and just above); the PPS wont be punished...any delays will be short term.
Stay thirsty my friends; it will be quenched shortly.
My gut instincts tells me Gerald (and team) many delay the BIG LymPro news until after New Years (and no more tax loss selling pressure either). Also, the stock has been basing around $.08 for awhile; which is extremely healthy for the next leg up (which I believe will be a the most powerful wave of them all).
Keep the faith my brother......I think their will be many more surprises along the way too....many subtle hints are given if people are capable of reading between the lines.
In 2015 = ACTIONS ...will finally speak LOUDER than words.
REVENUE!!!
Greetings JP; the feelings our mutual. As you know, we are all in this together....its been a tough and trying journey here. Lets sit back and relax...enjoy the holidays...January is our month. Cheers!
JP:
It will all come together; I believe any blockbuster news will happen in January. Just keep the faith and don't worry as much with day to day activity or what needs to be accomplished by Year end.
In my opinion, I see a company laying the proper foundation for massive growth and expansion which is on the way (I know Gerald has to be as excited as his personal credibility and fathers are at stake). Moreover, the key hires and all the ongoing work with creating an incentive plan ahead of important news ...are all signs of good things on the way.
Note: you may not get rich overnight; but you will do very well over time with this investment....I added 275,000 shares a few days ago..my confidence continues to grow each day...as we move closer to all the big news that Gerald has promised (and has outlined in the milestone plan). Lastly, the JP Morgan conference participation will be HUGE!!!!!
More News - ODD filing for MANF - retinal artery occlusion (RAO).
SAN FRANCISCO and GENEVA, Dec. 19, 2014 (GLOBE NEWSWIRE) -- Amarantus BioScience Holdings, Inc. (AMBS), a biotechnology company focused on the development of diagnostics in Alzheimer's disease and therapeutic products in the areas of neurology, psychiatry, ophthalmology and regenerative medicine, announced that it has applied to the U.S. Food & Drug Administration (FDA) for Orphan Drug Designation for its investigational drug MANF (mesencephalic-astrocyte-derived neurotrophic factor) as a treatment for retinal artery occlusion (RAO). RAO is a blockage of the blood supply to the retina which causes severe and sudden loss of vision.
MANF, a naturally-occurring protein that reduces and prevents apoptosis (programmed cell death) in response to injury or disease, was discovered utilizing Amarantus' proprietary PhenoGuardTM Protein Discovery Engine. Pre-clinical data showed that MANF provided protective functional effects in an animal model of RAO. Moreover, toxicology studies have demonstrated that MANF was well-tolerated following a single intravitreal administration of a therapeutically relevant dose.
"Filing our second Orphan Drug Designation for MANF is an important component of our regulatory strategy for the program," said Gerald E. Commissiong, President & CEO of Amarantus. "We believe that our pre-clinical efficacy data with MANF supports its use in ophthalmologic disorders such as RAO and retinitis pigmentosa (orphan status applied for in October 2014) where there are currently limited or no treatment options available. We are extremely encouraged by our data and believe MANF has the potential to provide meaningful changes to the quality of life of patients and their families."
The FDA Orphan Drug Designation program provides a special status to drugs and biologics intended to treat, diagnose or prevent so-called orphan diseases and disorders that affect fewer than 200,000 people in the U.S. This designation provides for a seven-year marketing exclusivity period against competition, as well as certain incentives, including federal grants, tax credits and a waiver of PDUFA filing fees.
About Retinal Artery Occlusion
Retinal artery occlusion (RAO) is a rare eye condition caused by a loss of blood supply to the inner layer of the retina resulting in acute and often severe vision loss. RAO is further classified as central or branch retinal artery occlusion, respectively, depending on the location of the occlusion. The currently-available treatments are aimed at opening the occluded artery before irreversible damage occurs and most often do not improve visual acuity above natural history. There are no effective neuroprotective agents for the treatment of acute retinal ischemia available. The prevalence for RAO is approximately 10,450 patients in the United States.
Well...its seems your reached an end to your journey here. Since you have convinced yourself serious dilution is imminent; why keep posting and stating your case.
Good luck on your new investments!!!!
I have posted the LymPro section of the November 7th 10-Q (look at the last sentence....."92% co-positivity and 91% co-negativity with an overall 95% accuracy rating for LymPro".
Please work harder to get your facts straight!!
LymPro Test ?
The Lymphocyte Proliferation Test ("LymPro Test ?", or "LymPro") is a diagnostic blood test for Alzheimer's disease originally developed by the University of Leipzig in Germany. The test works by evaluating the cell surface marker CD69 on peripheral blood lymphocytes following a mitogenic stimulation. The underlying scientific basis for LymPro is that Alzheimer's patients have dysfunctional cellular machinery that inappropriately allows mature neurons in the brain to enter the mitotic process (cell division /cell cycle). When this happens the neurons start the cell division process, but cannot complete that process. As a result, a number of cytokines and other genes are upregulated, ultimately leading to cell death by apoptosis. This inappropriate cell division activation process is also present in the lymphocytes of Alzheimer's patients, as lymphocytes share a similar cellular division machinery with brain neurons. We measure the integrity of this cellular division machinery process by measuring CD69 upregulation in response to the mitogenic stimulation. If CD 69 is upregulated it means that the cellular division machinery process is correct and Alzheimer's is not present. If CD69 is not upregulated, it means there is a dysfunctional cellular division machinery process, and Alzheimer's is more likely. To date, data has been published in peer-reviewed publications on LymPro with 160 patients, demonstrating 92% co-positivity and 91% co-negativity with an overall 95% accuracy rating for LymPro.
I am an Avanir shareholder ...got in at the low $5's about a year ago. Also, I own the same amount in HALO; and I believe HALO has significant upside from here...so many reason to own the stock...PEG results, Partnerships, more ENHANZE deals, buyout, etc.
Lastly, many Pharma's need drug delivery technology that improves their toxicity; so I believe HALO is ripe and positioned very well to succeed going forward.
Why would anyone sell now based on a $17 all cash offer. I would wait for another bidder to surface and defer any 2014 capital gains taxes...could be a $21 ++ offer within days or weeks.
Management wants to protect their jobs; hence, they took a lower buyout offer. We will see how the PPS reacts; it will need to move north of $17 if a white knight will pursue at a higher prices.
I want $21-$22....fair value as of today and what the Wall street analysts had as a price target.
No problem! Go to www.amarantus.com
Everything you need to know. Cheers!
Risk off trade today...biotechs selling off across the entire sector (AMBS is fundamentally very strong). Also, the future PPS movement will be based on news driven events....believe in the Science and credible management team...everything else is noise. GLTA!!
Spin Out - Diagnostics division...may acquire additional diagnostic assets that would help bolster a successful Diagnostic division spin-out. What other surprises does Mgt. have coming.....sounds like something is imminent...:)
Per the Blog:
"As the launch of LymPro nears, the company is also looking to maximize the value of the investment we have made in the asset since acquiring it in late 2012. As a holding company, Amarantus is continuing to evaluate methods of returning value to shareholders, including a potential spinoff of the company’s diagnostic division. In addition to LymPro and our NuroPro Parkinson’s diagnostic, we are actively evaluating additional complementary late-stage neurology-focused diagnostic assets that would bolster our diagnostic division and make for a successful ‘spin-out’ while concurrently returning value to our shareholders. We believe we will be able to execute on this strategy in the near-term.
Happy Thanksgiving to everyone..and to a prosperous and succesfull 2015.