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Halo is owed a response in 30 days...not necessarily a final decision. Agree! The good news; if HALO Mgt. can prove the clotting can be managed and is not a direct result of PEG20 solely (more based on the other drug cocktails that are mixed with it).
It should bode well for a faster decision. Time will tell......we shall see what direction the company and trials will go in sooner than later.
10-k release was delayed to take additional time to complete it for new inclusions...why would you delay the 10-k and release it days later. Expect Mgt. to take every extra day allowed and file close to extension cut off date (before its considered late).
Most importantly, they have to mid April. Too many here are so impatient..so much going on behind the scences. Patience!!!!
Then its simple; Roche will need to lower its pricing to compete effectively. I am sure their are doctors who will maintain prescribing a branded product is better (for something very serious like Breast cancer). So I dont believe this will have a very dramatic affect ....but it will certainly lower the prospects of revenue expectations going forward.
Outstanding analysis Risk; your due diligence is very good and having the visibility to know what is potentially expected in regards to LymPro (or any other assets)....can helps us all out to determine the future upside potential for the PPS.
Rod:
Are you implying that HALO will get FDA approval for the Hylenex Label change since its over 60 days?
Another example of fast FDA required response times is Hylenex label change to include insulin pump data. Regs say Halo can submit label change without prior authorization and FDA has 30 days to respond. Lack of response within 30 days is automatic approval. Halo is in talks with FDA over 60 days already. Nothing is ever fast, simple or easy.
FDA Clinical Hold on PEG20 - Please Read!
Will the FDA really respond in 30 days?
Posted by BO ( ymb ).
Will the FDA really respond in 30 days?
There seems to be a little confusion about this. Whitten, on the last conference call, and at the Wedbush conference said that the FDA "indicated" that they would respond to Insmed's response within 30 days after receipt.
IMO, indicated may not be the appropriate word. According to the Code of Federal Regulations, Title 21, section 312.42, the FDA is obligated to respond within 30 days.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.42
FDA shall respond in writing to the sponsor within 30-calendar days of receipt of the request and the complete response. FDA's response will either remove or maintain the clinical hold, and will state the reasons for such determination. Notwithstanding the 30-calendar day response time, a sponsor may not proceed with a clinical trial on which a clinical hold has been imposed until the sponsor has been notified by FDA that the hold has been lifted.
HyQvia - FDA decision due no later than around June 2nd
Baxter Submits Amended BLA to U.S. FDA for HyQvia for Primary Immunodeficiency - 12/02/2013
DEERFIELD, Ill., and SAN DIEGO, DECEMBER 2, 2013-Baxter International Inc. (NYSE:BAX) and Halozyme Therapeutics, Inc. (NASDAQ:HALO) announced today that Baxter has completed submission of an amended biologics license application (BLA) to the United States Food and Drug Administration (FDA) to re-initiate the review process for approval of HyQvia [Immune Globulin Infusion 10% (human) with Recombinant Human Hyaluronidase] facilitated subcutaneous infusion for the treatment of adult patients with primary immunodeficiency (PI).
HyQvia is a combination of human immune globulin (IG) and recombinant human hyaluronidase. Baxter and Halozyme submitted additional preclinical data that was requested from the FDA in 2012, and expect a six-month review period.
"We believe that if approved, HyQvia may become a valuable option for patients with immune deficiency as it allows for the delivery of a full dose of immunoglobulin often in a single site every three to four weeks, in the comfort of a patient's home," said Ludwig Hantson, Ph.D., president of Baxter's BioScience business. "As a long-standing leader in the IG market, we are committed to continually developing new treatment options like HyQvia that have the potential to make a meaningful difference in the way patients are treated."
The original BLA submission for HyQvia was based on results from a Phase III, prospective, open-label, non-controlled multi-center clinical trial, which evaluated the safety and effectiveness of HyQvia in the prevention of acute serious bacterial infections, rate of adverse reactions and the pharmacokinetic parameters compared to immunoglobulin administered intravenously. In the tolerability assessment of HyQvia, the most frequently reported adverse reactions for patients who received HyQvia were local infusion site reactions (such as pain or discomfort, redness, swelling, and itching) and headache, nausea Less
Correct. for MabThera...but it will probably be amortized over 10 years (just like the Herceptin payment from Roche).
Analyst issue comments:
WS Analyst reaction and comments to PEG20 trial halt
Piper Jaffray analyst Charles Duncan said he expects the pancreatic cancer halt to be resolved in "weeks, not months" and that it would not hurt the broader technology platform as the dosing levels varied significantly from those of Hylenex.
Jefferies & Co analyst Eun Yang maintained her assumption that the pancreatic cancer treatment would be launched in the United States and Europe by 2019, and generate combined peak sales of about $548 million in 2027.
UBS maintains $14 price target. Thinks Hylenex Diabetes potential upside surprise. Gives $5 value to PEG but not changing estimate.
BMO Capital analyst Jim Birchenough, M.D. is out defending Halozyme BMO Capital analyst Jim Birchenough, M.D. is out defending Halozyme Therapeutics (NASDAQ: HALO), which is down 29% after temporary halt of phase 2 trial enrollment and dosing for PEGPH20 in pancreatic cancer. "We believe HALO weakness represents an over-reaction to today's news given that PEGPH20 represents only ~$1.00/share in our NPV estimate for the company," Birchenough said. "Any imbalance in thromboembolic risk should be easily manageable with ASA +/- anticoagulant, as is done commonly with large cancer drugs like REVLIMID." He added, "Thromboembolic risk for an IV formulation of PEGPH20 has no implications for the broader PH20 SubQ platform and we continue to see upside to recent EU approvals of HERCEPTIN SC and MABTHERA SC." The analyst maintained an Outperform rating and price target of $24.00. Less
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Eltoprazine remains by far the single most catalyst that will drive the PPS upward (in my opinion). Mgt. has every incentive to move this compound forward in LID and ADHD (watch the PPS double within days on this announcement). Also, I believe PhenoGuard offers incredible upside as knowing what potential Pharma. wants a Long term relationship and equally validates the Science would be a huge vote of confidence as well.
In addition, I think Mgt. has every incentive to get the stock price significantly higher before the Uplist; but I do think the HUGE announcements will come post the Uplist (as that is when the institutional crowd will get rewarded...very classic move for most companies that Uplist).
Risk: Per the latest Blog; he said anytime in 2014 (depending on market conditions).
With Becton Dickinson (or possibly Quest diagnostics) become deeply involved and entrenched here; in my opinion we are in good hands should the LymPro relationship continue long term ....BD (or Quest) is a powerhouse and knows the ropes in the Diagnostic field, along with understanding govt.regulations, reimbursement and requirements.
As all signs point to keeping LymPro in house; the recent hires bode well too (there are real heavy hitters joining AMBS....I am confident that these guys will figure it all out and stay on track...my money says so).
Uh Oh JP: You have some competition my friend. I see what you see...and have other holdings that I am clinging on to every day...waiting for something to trigger me to significantly increase my AMBS position. A STEAL below $.10!!!!
Alapis: I am not on your side whatsoever; I am tired of reading negative posts for those who dislike the company (why are you here)?
REALITY check: they filed an extension; its not a late filing as Warpcore and other have clarified properly.
The Uplisting is very critical; so the financial house must be in order.. Upon filing the 10k by mid April evrything will be OK; but lets do the things that we can control a better way...its all about the Science here...that is really what matters.
BE ON TIME Mgt!!!
Marc Faerber is not out (he is the Corp. controller now); he is just being replaced with someone that will sit atop the financial throne there. I realize the AMBS did not violate any SEC laws and everything will be fine as long as they file the 10k by mid April.
However, in regards to the upcoming Uplisting; I just dont think drawing any attention to extending the 10k filing and keeping March Faerber in control there have been prudent (just wish the 10-K was filed on time and would have been a non issue) as you need to build confidence with institutions that you are capable of handling these responsibilities properly.
Lastly, I cant wait until an IND is filed, Orphan Drug designation is reached, Eltoprazine trials are restarted, MANF or LymPro data is realeased (the week could have definitely started alot better here and its a long time coming).
Amarantus Appoints Robert Farrell, J.D. as Chief Financial Officer
GlobeNewswire
Amarantus BioScience Holdings, Inc. 50 minutes ago
SAN FRANCISCO, April 1, 2014 (GLOBE NEWSWIRE) -- Amarantus Bioscience Holdings, Inc. (AMBS), a biotechnology company focused on the discovery and development of novel diagnostics and therapeutics related to cell cycle dysregulation, endoplasmic reticulum stress, neurodegeneration and apoptosis, today announced the appointment of Mr. Robert Farrell, J.D. as Chief Financial Officer. Mr. Farrell brings over 20 years of healthcare, public company and CFO experience to Amarantus. Mr. Marc Faerber will continue with Amarantus in his new role as Corporate Controller and Vice President of Financial Operations.
"Amarantus is very well positioned to generate significant shareholder value through the further development and commercialization of its key assets in the months and years ahead," said Mr. Farrell, Amarantus' newly appointed Chief Financial Officer. "I am pleased to be joining now at this critical juncture as the Company prepares to uplist its common shares to a national stock exchange in 2014 as we commercialize LymPro, initiate a Phase 2B clinical trial for Eltoprazine in Parkinson's disease and prepare the MANF Program for an orphan drug designation submission. We expect 2014 to be a transformative year for Amarantus as we lay the groundwork for long-term shareholder value creation."
Mr. Farrell served as Chief Financial Officer of Titan Pharmaceuticals from 1996 to 2008, and as President and CEO from 2008 to 2010. During his tenure at Titan Mr. Farrell was responsible for all SEC filings, fund raising, financial and tax planning strategies, mergers & acquisitions, corporate partnerships, licensing transactions and financial operations, where he raised over $390M via public equity and non-dilutive financings, including seven corporate partnerships. Mr. Farrell most recently served as CFO at Sanovas, Inc. Mr. Farrell previously served as CFO, Corporate Group Vice President and General Counsel at Fresenius USA and Fresenius Medical Care where he completed 6 corporate partnership and M&A transactions totaling over $4B. Mr. Farrell also previously served as the CFO for the Institute for One World Health in San Francisco and currently serves on the Board of Directors of Prime Genomics, Inc. Mr. Farrell holds a J.D. from the University of California's Hastings School of Law.
"We are extremely pleased to add Robert Farrell to our team as we begin to build momentum towards uplisting our common shares on a national stock exchange in 2014," said Gerald E. Commissiong, President & CEO of Amarantus. "I am excited to work closely with Bob as we move our products ahead in order to maximize the value of our equity and mitigate risks going forward. Bob will bring invaluable experience to our team as we continue to build Amarantus into a world class company dedicated to bringing meaningful solutions to patients."
Uplist planned for 2014 (not specifically targeted for Jun/Jul.)..see latest Blog today.
Thanks Barcode and great due diligence here. You are definitely one of the individuals to follow and read your posts along the way.
I hear ya; its all good. We are all in this sandbox together...the volatility in the stock price causing emotions and sentiment to run high...need the stabilize the PPS and grind steadily higher (the positive news has not been factored properly in the stock price due to manipulated activity...I hope this time around that will all change and rid the stock of this crap).
In Gerald I trust......Q2 2014 will the time AMBS vaults to a superstar status in the bio. world...stake your claim to fame.
Interesting Zoom: you seem to want to spin my posts a completely different way. I did say that I dont mind getting direct tweets from Gerald (our CEO) well ahead of public information (I look forward to getting them). I am long and strong and support Gerald (executing with great precision and building his world class management and BOD team). No small feat for a penny OTC stock.
Translates to acceptance of social media on my end (do you comprehend English)?
Note: Doc is a blessing and has already made a very positive impact...lets keep it a level playing field for all. The PPS is very volatile because there just may be those in the know who are capable of trading large positions and is able to time the exact news releases due to inside info.....sound fair?
Oh...so you do seem to get and acknowledge that PhenoGuard has significant potential? Might be the Holy grail...thats my point. Everyone is focused on LymPro...I am looking the other way.
I am glad you have this all figured out...what a relief. My advice is you go over and read Watsonhelpers post about walking a fine line and what information should be disseminated to whom ..in advance of publicly released info to all.
I appreciate getting a heads up and tweets directy from the CEO; but the last thing we need is shareholder lawsuits because certain non management individuals are getting advanced information before and ahead of others...dangerous precedent?
You are entitled to your speculative opinion; and I am entitled to my opinion (and what my gut instincts are telling me as well). If MANF evolved out of the PhenoGuard platform....could be additional compounds that evolve from PhenoGuard as well (as long as a very significant Pharma. partnership too).
In terms of being impressed because someone has 20mm shares; I could care less what you or anybody else owns...just keep stroking your own egos...most dont care what anybody else owns.
In fact, if i owned that many shares; I wouldnt be sharing that with a bunch of retail longs on a message board...seem logical to you?
Doc: A wasted effort to engage and debate with BH; your time is way worth more informing the rest of us as to giving us your insight in regards to your connections. A highly successful investor knows how to perform their own due diligence ....invest in the Science and the caliber of the Management team (an All star cast here...kudos to Gerald and his father for assembling this world class team).
We are on the verge of something special here....still an early stage and preclinical oriented company...but my due diligence tells me its going to be very highly successful as the Science is proven and validated across so many highly regarded scientific institutions and research facilities accross the world ...FACTS are FACTS.
What excites me is the potential for PhenoGuard....keep this close to your vest everyone (among so many other things). MANF evolved from the PhenoGuard platform....so whats next???? Watch and learn!!!
200 day moving average is $.06....is the chart broken and we test that area of support this AM? It will be an opportunity to load up...fundamentals are stronger now than ever in the company's history (per Geralds recent tweet).
Go Get Em........
For those who are tooting their own horns saying big news is imminent; it doesnt take rocket science to figure out its inevitable at some point. There has been a rather long delay in meaningful news; I can guess like anybody else that big news is coming this Monday (law of averages; its going to happen sooner or later).
I REPEAT...nobody here has inside information as they portray they do...just a fantasy and figment of everyone's imagination.
Great reality check WarpCore. I am amazed how many believe everything they read here. Maybe this person might be right; but lets be careful and do our own due diligence when making investing decisions.
Also, who knows which persons here are responsible for the big price swings.....food for thought!!!!!
I am going to make an interesting prediction; we will bounce off the 200 day moving average ...at $.06 tomorrow morning before we resume an uptrend. A washout will occur on good volume; but reverse and closer green by the end of the day.
Interesting speculation and development:
It makes sense to me and I presume a conversion ratio from taking the Nasdaq listed stock (for what company is acquired and listed) and converting AMBS shares will be necessary. I always get antzy as when someone tries to predict an exact day for a news release (hmmm, Friday or Monday)...how would you know? As if they have inside information or knows someone on the management team.
Most importantly, I think its inevitable that lots of news is coming sooner than later (just common sense would tell me to Uplist; they will have to get the stock price significantly higher or do one very nasty RS. If for any reason we can avoid a RS; I will be providing a full paid trip to Tahiti for all.
Another excellent post here!!!
GC (and his team..lets give credit to all working in the decision making process here). We are a preclinical stage company; WS wont assign a significant market cap until SERIOUS progress is made....like getting an IND filed, moving LymPro forward to the goal line, starting up the Phase IIb Eltoprazine trial or any partnership or licensing deal is announced...or the Uplisting is finalized.
The PPS is a pressure cooker right now; but one day soon the lid will be blown off...all the ingredients were added to the recipe recently with the LPC financing deal, added more talent to the management and operations teams... and the addition of the Eltoprazine compound (possible 2-3 distinct indications there alone)...need a spark and KABOOM!!!!
Great chart and analysis. I think this is a very important (possible) indicator as to when the sector might bounce once or return to glory again.
Its really oversold; but I have seen this sector take mercy on souls over my lifetime (no guarantees). But I thought AMBS has held up very well over the last week compared to the IBB index (and companies in the sector).
Nice post sharpei!!!!
JP: It certainly lends to the reality that JNJ just may be quietly building their own infrastructure within AMBS...and thats more than likely no coincidence. Amarantus was invited to the Janssen pharma. incubator as and up and promising biotech company....and it would be naive for JNJ to not do careful due diligence ....as they have an incredible opportunity to invest into the AMBS MANF technology and pipleline in the early going.
The Science is compelling and has been thoroughly tested at many prestigous universities and research centers....what other validation is needed here. For one, I think this just might be one of the most grossly undervalued investments out there....and the timing to get aggressive and build a large and strong position is as good as it gets right now. I added 75k on Friday...hope to add 750k-1mm real soon...as time is running out before the PR blitz is let loose leading to the Uplisting.
Excellent JP! Also, I think this statement was very important as well (from the latest Blog). Smell like JP Morgan and other large interested investors? Time will tell..but the foundation is being set for a big run in the PPS (todays market prices are a gift...who says xmas cant come early). Huh?
"As we move from today into tomorrow, we believe we are very well positioned to gain the attention of larger institutional investors seeking to gain access to the Company’s pipeline and potential for the future while significantly reducing the financial risk typically associated with Over-The-Counter stocks."
Gipper:
Thanks for your continued efforts here as well (team effort...and so many other significant contributions by others too). The incredible financing deal was the missing link; its all fun going forward.
Its sort of going to a casino and winning early; can play with the houses money the rest of the day. Go Gerald (and his amazing and talented team)!!! ..lets throw a TGIF in here too.
From the Yahoo MB: Check out the analysis here; Gerald was quoted as telling investors to read the 8-k very carefully:
In connection with the transactions contemplated by the Purchase Agreement, the Company has registered with the U.S. Securities & Exchange Commission the following shares of Common Stock:
[TRANSFER AGENT]
(1) 4,000,000 shares of Common Stock that have been issued to the Buyer upon purchase from the Company by the Buyer on the date of the Purchase Agreement (the “ Initial Purchase Shares ”).
(2) 6,000,000 shares of Common Stock that have been issued to the Buyer as an initial commitment fee on the date of the Purchase Agreement (the “ Initial Commitment Shares ”).
(3) 76,500,000 shares of Common Stock to be issued to the Buyer upon purchase from the Company by the Buyer from time to time (the “ Purchase Shares ”).
(4) 3,500,000 shares of Common Stock to be issued to the Buyer upon purchase of Purchase Shares from the Company from time to time as an additional commitment fee (the “ Additional Commitment Shares ”).
Now do the math on the $19.6M in expected proceeds against 76.5M toto be issued to the Buyer upon purchase from the Company by the Buyer from time to time (the “ Purchase Shares ”).
It's 19.6/76.5 = 25.6c PPS!!!! In other words, this appears to be the average pps level that GC expects to execute the purcahse agreement at. Somebody tell me what I've missed here?
It sounds like he might be part of a network of trade groups with some deep pockets. If so, there may be some big buyers who want to establish positions quickly. Sounds good to me!!!!!
As long as they are flipping the PPS like hamburgers like Solantey. LMAO!!
Risk: Yes, you can definitely get an Orphan indication before an IND is filed. Remember, Insys did that with their IPF drug (Orphan approved but it never made it to the IND stage whatsoever).
Great post gipper:
I think you have summarized reality quite well. And to everyone else; please dont get discouraged by the lack of PPS movement today.
You will get motivated sellers who will dump their positions into good news (it happens all of the time with even the best companies out there).
The future is extremely bright and Gerald is very accurate to say they have removed the obstacle to unlock tremendous value in the stock going forward.
Are you looking at the bigger picture? They can now move forward with Eltoprazine in Parkinsons LID and ADHD trials. Are you kidding me...they have big $$$ to move all their programs forward.
Unbelievable news!!! This is HUGE!!! If you only take a look at what a huge funding arrangement did for NVLX (Lincoln park was involved with $27mm capital raise with them....very recently ... and what that transaction did for their respective stock price....you have to be really excited about the AMBS and this $20mm purchase agreement with Lincoln too).
Finally, AMBS mgt. is now in complete control of their destiny (financially speaking) and I believe our PPS will finally ascend upward...as Wall Street can discount all of the other great things going on with Amarantus.
http://finance.yahoo.com/news/nuvilex-announces-27-million-funding-140000013.html
So few details regarding this story...will take plenty of time to bring it to fruition. I dont see any competitive threats against LymPro whatsoever.....this new test is in preclinical stages.
JP: thats a very significant validation and huge vote of support from Gerald. I am confident that buying might start sending the PPS us up early next week...as Gerald has clearly hinted that things are going quite well.