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$$$ CYTX $$$
Looking to make a big move today...lots of volume lately...interest is picking up...PPS is rising...Time to get in before the huge bounce!
$CYTX$
More than 3 Million shares acquired through insider trading since January...The BOD sees big things coming...
2016-01-28 HEDRICK MARC H
President and CEO 70500 CYTX Options Awarded
2016-01-28 Girao Tiago
VP & Chief Financial Officer 35250 CYTX Options Awarded
2016-01-28 KESTEN STEVEN
Exec VP and Chief MO 47000 CYTX Options Awarded
2016-01-28 Girao Tiago
VP & Chief Financial Officer 35250 CYTX Options Awarded
2016-01-04 HEDRICK MARC H
President and CEO 834210 CYTX Options Awarded
2016-01-04 KESTEN STEVEN
Exec VP and Chief MO 699660 CYTX Options Awarded
2016-01-04 HARRIS JOHN DAVID
VP and GM Cell Therapy 349830 CYTX Options Awarded
2016-01-04 Girao Tiago
VP & Chief Financial Officer 349830 CYTX Options Awarded
2016-01-04 HAYDEN JEREMY B.
General Counsel & VP of BD 255645 CYTX Options Awarded
2016-01-04 LYONS GARY A
53820 CYTX Options Awarded
2016-01-04 Naughton Gail K
53820 CYTX Options Awarded
2016-01-04 Thompson Tommy G
53820 CYTX Options Awarded
2016-01-04 RICKEY DAVID
53820 CYTX Options Awarded
2016-01-04 Hawkins Richard J
53820 CYTX Options Awarded
2016-01-04 HAWRAN PAUL W
53820 CYTX Options Awarded
$$$CYTX$$$
Looking for the RSI to get back to 50 today, and possibly move north. Too many things on the horizon right now, and the interest is picking up. This is one of the lowest Nasdaq stocks you will find, and they are going to be making great strides to maintain that listing.
Best of luck everyone!
$$$CYTX$$$
Getting pretty exciting around here...interest is picking up...volume is picking up...PPS is going up!
Possibly as a way to garnish more attention from Big Pharma companies to gain partnership. If you remember, Elto Trials were set to start running, and a PR was even announced when the first patient was enrolled. Then when there was realization that with ODD, more benefits can be gained before the successful completion of the Phase 2B/III trials. Elto has already been given to more than 600 patients with no significant side effects, so the trial is more of a paperwork drill to show efficacy and tolerance more than anything, and with a proof of concept that has already been done, the trials would go smoothly.
Point is, with ODD designations, it shows that the FDA is on board, and it provides a 7 year Exclusivity period against competition...as well as possibilities for funding from grants tax credits and waiver of PDUFA fees.
With FDA endorsement, the trials will be commencing again soon...I have thought all along that they never should have stopped the trials, but with an agreement for funding from the Army and Rutgers for ESS, it allowed time to reevaluate the rest of the pipeline. I am guessing that as soon as trials start up again, there will be information coming out about paring MANF from the recent hiring of the WallachBeth firm.
Just my two cents...
This may be the beginning of the turn around...
I guess we shall see when the 16th rolls around to see how many more shares the Toxics convert.
In My Own Personal Opinion Of Course!
Long AMBS!
So, who is going to be in New York Tomorrow?
http://www.otcmarkets.com/stock/AMBS/news/Amarantus-to-Present-at-Source-Capital-Group-s-2016-Disruptive-Growth--amp--Healthcare-Conference?id=124943&b=y
The Company's presentation will be given on Wednesday, February 10, 2016 at 12:30 pm by Gerald E. Commissiong, President & CEO of Amarantus, in the OneMedMarket Venture Track. The presentation will provide an update on the Company's regulatory interactions with FDA. Amarantus' CEO will be available for one-on-one meetings at the conference.
Understanding the need to keep asking for money to keep the show on the road, but at some point the money borrowed needs to go towards advancing the pipeline. There are many believers here, and there have been many publications published about MANF, Elto, ESS, and Phenoguard. Something needs to go further into phase III. Should never have stopped the Elto trials in my opinion. Sure ESS has a lot of interest, but in my mind, having two irons in the fire would have more interest in having a one horse show.
Eventually the toxics will run out of shares, but at what level is the question? Hopefully Dustin is not dumping his shares, and will keep this above the pivotal .09 to .16 range.
It seems that he has a vested interest in this as well, and putting up another $2Million of his own funds is a pretty big statement. GC owning 100,000 shares is nothing, but owning $2Million worth of stock is huge.
Why would anyone put up that kind of money unless there were writing on the wall that made this deal appealing. ESS Trials are going to happen...funding is not coming from AMBS, so no matter where the PPS goes in the meantime is irrelevant; however, when ESS is proven to be successful, everyone will be scrounging to pick up shares.
Just a thought.
In My Own Personal Opinion Of Course!
Long AMBS!
Thanks for the kind words Christjamin.
Gave you a member mark/Follow!
I too believe it is unproductive to bash stocks...unless you have shorted it, then there really is no purpose. No one to blame but ourselves for not doing enough research and not bailing out before the TOXICS took control.
However, I am hoping that this new infusion of money may be enough to buy out the rest of the toxic holders of the Series H,
I also like the several instances of holding off for 7 weeks, and the silence order till March 12th...
Something must be in the works that I am guessing will be announced mid March. Until then, I will continue to hold and possibly add on the dips to continue to average down!
I'm under $1.00 finally after several rounds...I get hopeful every time it starts to go up, but it seems that we have been so low lately that the profit taking is holding us back. We really could use a catalyst to get this thing moving quickly!
Best of Luck My Friend!
Long AMBS!
I don't know...fluff or not, publicity is publicity.
In the not so famous words of Fred Durst, "Even Negative publicity is still publicity"!
I believe in MANF, and there has been many articles written and published in many different journals touting the possibilities of MANF in many different diseases and defects.
If it opens up eyes in the Asian communities, then I am all onboard with publishing articles around the world. The more buy in, the better off we as shareholders and the company as a whole will be. Get the Market Cap back to where it needs to be.
Again, another small step, but eventually we could be walking again!
In My Own Personal Opinion Of Course!
Long AMBS!
So, the Chinese are on board???
http://ih.advfn.com/p.php?pid=nmona&article=70181251
Amarantus Announces Issuance of Chinese Patent Covering Use of MANF for the
Treatment of Parkinson’s Disease
- Patent issuance will provide intellectual property protection in China for protein therapy,
gene therapy and cell therapy applications of MANF -
SAN FRANCISCO, CA – January 29, 2016 – Amarantus Bioscience Holdings, Inc. (OTCQX: AMBS), a biotechnology company developing products in Regenerative Medicine, Neurology and Orphan diseases, today announced the issuance of Chinese patent number ZL2009801163060 entitled “Neurodegenerative Disorders” covering the use of MANF for the treatment of Parkinson’s disease and other neurodegenerative conditions. The claims issued extend patent coverage for MANF protein therapy, gene therapy and cell therapy applications into 2029.
“The Chinese market represents a potential significant market opportunity for Amarantus,” said Gerald E. Commissiong, President & CEO of Amarantus. “MANF has demonstrated proof of concept in various efficacy and delivery animal models of Parkinson’s disease. Going forward, the Company will look to partner the development of MANF with a group in China capable of bringing this technology to market in that region.”
The key claim issued in this patent is “Use of MANF for the manufacture of a medicament for administration to the substantia nigra region of the brain for treating Parkinson’s disease.” The substantia nigra is a key area of the brain where dopamine producing neurons degenerate in Parkinson’s disease. Additional claims covering combinations of MANF and other therapeutic moieties were also granted. This patent adds to Amarantus’ extensive international intellectual property portfolio covering compositions of matter, methods of use and formulations for MANF.
About Mesencephalic-Astrocyte-derived Neurotrophic Factor (MANF)
MANF (mesencephalic-astrocyte-derived neurotrophic factor) is believed to have broad potential because it is a naturally-occurring protein produced by the body for the purpose of reducing and preventing apoptosis (cell death) in response to injury or disease, via the unfolded protein response. By manufacturing MANF and administering it to the body, Amarantus is seeking to use a regenerative medicine approach to assist the body with higher quantities of MANF when needed. Amarantus is the front-runner and primary holder of intellectual property (IP) around MANF, and is initially focusing on the development of MANF-based protein therapeutics. MANF's lead indications are retinitis pigmentosa (RP) and retinal artery occlusion (RAO), and additional indications including Parkinson's disease, diabetes, and Wolfram's syndrome are currently being evaluated. Further applications for MANF may include Alzheimer's disease, traumatic brain injury (TBI), myocardial infarction, antibiotic-induced ototoxicity and certain other rare orphan diseases currently under consideration.
Its not a miracle cure...only a step in the right direction.
No one said it will fix all the problems..
Don't get upset.
GC has us all in a $HIT storm with laying in bed with dirty financiers...none are hurt more than AMBS Shareholders, and I assure you I own tens of thousands of shares...and am still way under water, so unless you own more than say...$25,000 or more in shares, you can't be half as upset as I am.
I am only saying that I know MAGNA has already converted nearly 2 million of their shares at a range of most at $1.25...all the way down to $0.40 so, a significant chunk of their $2.5 million has been repaid by them dumping shares on the open market as shown by our significant increase over the past year...or from the reverse split.
I am not saying you are that far off either, but MAGNA has dumped more than pretty much everyone else...We all know they are in the business to make money, but some are dirtier and sleezier than the others.
If this is a bridge to better things, then so be it...if March 12th is something significant, then so be it...if Avant is going to be sold to Roche, then so be it...I just want to recoup part of my finances as well. I do believe in the Pipeline, specifically in MANF...GC is just the current Captain of the boat sailing us into Turd infested waters. Eventually I hope for clear blue seas!
Best of luck...not trying to insult you...only trying to remain positive. Being negative all the time does no good!
In My Own Personal Opinion Of Course!
LONG AMBS!
Nope, I don't think I'm way off...especially when you still say ...
"This is but a small step on the road to recovery"
Go back and re read my earlier post where I compiled the math for you and broke it down.
Of particular interest in the latest filings I was interested in reading
In addition, the Company and certain of its investors agreed to a leak-out agreement dated January 27, 2016 pursuant to which the investors agreed to certain trading restrictions with respect to its holdings of preferred stock and convertible notes of the Company until March 12, 2016.
JJAAMMAANN Tuesday, 01/26/16 03:21:25 PM
Re: Slmiley post# 121791
Post # of 121907
The Series H converts are definitely hurting, but sooner or later, the conversions have to run out and MAGNA will be repaid. Yes, they can be death spirals, but if you add up the shares so far, it is nearly 2 Million...1,996,356 from the supplements you have listed thus far. From September through January 8th, the PPS averaged nearly $0.50, and when the 1,298,612 were converted back at the end of September, the price was about $1.25 considering that they were all sold, utilizing an average price would be:
1,996,356 Shares x $.5 PPS = $998,178.00
If you consider the September allotment alone selling for $1.25 per share, it would be:
1,298,612 Shares x $1.25 PPS = $1,623,265.00
then use the remaining shares at average...
697,774 Shares x $0.50 PPS = $348,872
41,623,265.00 + $348,872 = $1,972,137
Worst case scenario, they have only recouped $1 million, best case scenario they have recouped $2 million...either way, there is a light at the end of the tunnel!
Maybe there was something to that January 8th date given by GC?
Maybe the Toxics are depleted...or getting closer anyway...
Hope GC has something to present soon to get this thing rolling again!
http://www.amarantus.com/news/press-releases/detail/2020/amarantus-closes-5-5-million-capital-infusion-through-the
Quote:
SAN FRANCISCO and GENEVA, Oct. 1, 2015 (GLOBE NEWSWIRE) -- Amarantus Bioscience Holdings, Inc. (OTCQX:AMBS), a biotechnology company developing therapeutic and diagnostic product candidates for orphan indications and neurology, announced that it has completed the issuance of $2.75 million of newly designated Series H convertible preferred stock in a registered direct offering and $2.75 million in secured debt in a private placement for a total of $5.5 million to a single institutional investor. Both the Series H and the newly issued secured convertible debt are convertible into Amarantus common stock at $2.50 per share, subject to adjustment based on market conditions. In addition, $2.85 million in secured debt previously issued to Dominion Capital in connection with the acquisition of Cutanogen Corporation has been exchanged for the secured notes issued in connection with the secured debt financing agreement outlined above. In connection with this series of transactions, the Company issued approximately 3.8 million warrants to the Series H holders and secured debt holders exercisable for five (5) years with a fixed strike price of $2.00.
At closing, the Company simultaneously repurchased all of the remaining 1,260 outstanding Series G convertible shares, having a face value of $6,300,000, and 212,087 common shares held by Discover Growth Fund at closing, for a total of $4.75 million in cash. With the completion of this series of transactions, Discover Growth Fund no longer holds any securities of the Company and is precluded from trading in the Company's securities for a period of two (2) years.
In My Own Personal Opinion Of Course!
Long AMBS!
Looks to be a step in the right direction anyway. If International Infusion is putting up 1.5 million, and a private entity is putting up another 1 million, it is more than enough to cover the cost of the Toxic death spiral financiers.
Seeing how they have already converted more or less than half of their debt into shares and sold them on the market, there should be roughly 1-1.5 million left at most.
Seems to be a positive for GC so far, now for some kind of announcement that all the Toxics have been bought out, and the new Series H holders are forced to hold for at least 7 weeks. Which also leads me to believe that GC has another plan to have the additional financing completed prior to he 7 week deadline.
2.5 million is not significant at this point, but it does keep the lights on for other possibilities. It carries them through till mid March...
If the toxics are all cleared, the market will stop being flooded with shares, and we could start moving back towards the 50 DMA and possibly the 100 DMA.
Time will tell, but looks like some great buying at the end of the day.
Best of Luck Everyone!
In My Own Personal Opinion Of Course!
Long AMBS!
Thanks for the update, and for your DD.
I get how it is supposed to work, but will not hold my breath waiting for he LOI to materialize. I know GC made a lot of talk in the past about rewarding shareholders, but never made it clear how he was going to repay us loyals...
Whether that be some form of share reward, or possibly a dividend at a later date still remains to be seen. I don't honestly believe GC will share any of the 80 Million shares that he was able to get from Avant.
I would rather see one of the assets sold in order to pay for the others which are closer to production. Funding ESS and ELTO are my biggest dreams at this point. Whether that be from Grants, or Partners really doesn't matter to me...just knowing that they are funded will make the stock take off and maybe, just maybe I can recoup some of my losses thus far!
In My Own Personal Opinion Of Course!
Long AMBS!
Looks like everyone is holding onto their shares with a death grip...awaiting the next big announcement! Which could come at any moment now, but definitely by the summer's end!
Best of luck!
Patience will be rewarded here!
IMHO
So, what's your take Wolf?
Is anything going to happen at all...will the new shell stay Avant Diagnostics, or will it become Amarantus Diagnostics?
The 8K states "Merge into", not "Merge with"...
Will either company or owner prosper? or is it truly a pipe dream to pump both companies?
On January 19, 2016, Avant Diagnostics, Inc. (the "Company") issued a press release announcing it has entered into a non-binding Letter of Intent to merge into, Amarantus Diagnostics, Inc., a wholly-owned subsidiary of Amarantus Bioscience Holdings, Inc.
JP, I would definitely be onboard with a conference call.
Some things need clarification, and others need updating.
Looks like a little profit taking going on today...those who bought in at the .20 level are taking their rewards.
In My Own Personal Opinion Of Course!
Long AMBS!
Should be getting pretty interesting around here by say...July timeframe...The RPDD should take around 6 months to decide.
http://www.amarantus.com/news/press-releases/detail/2038/amarantus-requests-rare-pediatric-disease-and-orphan-drug
http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm
Therare pediatric disease priority review
voucher fee is intended to cover the
incremental costs for FDA to do a
priority review on a human drug
application that would otherwise get a
standard review. The formula provides
the Agency with the added resources to
conduct a priority review while still
ensuring a robust rare pediatric disease
priority review voucher program that is
consistent with the Agency’s public
health goal of encouraging the
development of new human drugs and
biological products for rare pediatric
diseases.
A priority review is a review
conducted with a PDUFA goal date of 6
months after the receipt or filing date,
depending on the type of application.
Under the PDUFA goals letter, FDA has
committed to reviewing and acting on
90 percent of the applications granted
priority review status within this
expedited timeframe. Normally, an
application for a human drug or
biological product will qualify for
priority review if the product is
intended to treat a serious condition
and, if approved, would provide a
significant improvement in safety or
effectiveness. An application that does
not receive a priority designation will
receive a standard review. Under the
PDUFA goals letter, FDA has committed
to reviewing and acting on 90 percent of
standard applications within 10 months
of the receipt or filing date depending
on the type of application. A priority
review involves a more intensive level
of effort and a higher level of resources
than a standard review.
Section 529 of the FD&
The Series H converts are definitely hurting, but sooner or later, the conversions have to run out and MAGNA will be repaid. Yes, they can be death spirals, but if you add up the shares so far, it is nearly 2 Million...1,996,356 from the supplements you have listed thus far. From September through January 8th, the PPS averaged nearly $0.50, and when the 1,298,612 were converted back at the end of September, the price was about $1.25 considering that they were all sold, utilizing an average price would be:
1,996,356 Shares x $.5 PPS = $998,178.00
If you consider the September allotment alone selling for $1.25 per share, it would be:
1,298,612 Shares x $1.25 PPS = $1,623,265.00
then use the remaining shares at average...
697,774 Shares x $0.50 PPS = $348,872
41,623,265.00 + $348,872 = $1,972,137
Worst case scenario, they have only recouped $1 million, best case scenario they have recouped $2 million...either way, there is a light at the end of the tunnel!
Maybe there was something to that January 8th date given by GC?
Maybe the Toxics are depleted...or getting closer anyway...
Hope GC has something to present soon to get this thing rolling again!
http://www.amarantus.com/news/press-releases/detail/2020/amarantus-closes-5-5-million-capital-infusion-through-the
SAN FRANCISCO and GENEVA, Oct. 1, 2015 (GLOBE NEWSWIRE) -- Amarantus Bioscience Holdings, Inc. (OTCQX:AMBS), a biotechnology company developing therapeutic and diagnostic product candidates for orphan indications and neurology, announced that it has completed the issuance of $2.75 million of newly designated Series H convertible preferred stock in a registered direct offering and $2.75 million in secured debt in a private placement for a total of $5.5 million to a single institutional investor. Both the Series H and the newly issued secured convertible debt are convertible into Amarantus common stock at $2.50 per share, subject to adjustment based on market conditions. In addition, $2.85 million in secured debt previously issued to Dominion Capital in connection with the acquisition of Cutanogen Corporation has been exchanged for the secured notes issued in connection with the secured debt financing agreement outlined above. In connection with this series of transactions, the Company issued approximately 3.8 million warrants to the Series H holders and secured debt holders exercisable for five (5) years with a fixed strike price of $2.00.
At closing, the Company simultaneously repurchased all of the remaining 1,260 outstanding Series G convertible shares, having a face value of $6,300,000, and 212,087 common shares held by Discover Growth Fund at closing, for a total of $4.75 million in cash. With the completion of this series of transactions, Discover Growth Fund no longer holds any securities of the Company and is precluded from trading in the Company's securities for a period of two (2) years.
$11,000 pre split still does not add up to 4.99% of the authorized or issued...good try though.
I TOO OWN MORE THAN $11,000 PRE REVERSE SPLIT!
If you remember, I have been here for quite a while as well...check your DD as well.
AMBS will do fine, and their pipeline is still intact. You are clamoring about the Diagnostics division, which AMBS Still owns you see... The LOI is only an "Intent", you see... It means they intend to do something, not that it is done, or will be done, only a possibility. Either party can still back out you see...
Best of luck none-the-less
In My Own Personal Opinion Of Course!
Long AMBS!
Looks good!
Thanks for the link Doog!
Wall Street analysts covering the stock, on a consensus basis, have a one-year price target of $8.666 on the equity. This is based on the 3 individual recommendations by the firms tracked by Zacks. The most aggressive target sees the stock headed to $12 while the most bearish has a $6 target. Zacks also uses a method in order to simplify the various recommendations into a 1 to 5 scale where 1 represents a Strong Buy and 5 a Strong Sell. Shares of Intellipharmaceutics International Inc. currently have an average broker rating of 1.43.
If we could get a 3rd consecutive 30% day, we could move back ahead of our 50 Day moving average!
Is the selling finally over....better things to come?
Sure would be nice to get some paperwork that stated so...
In My Own Personal Opinion Of Course!
Long AMBS!
Finally, it is nice to see a good GREEN day...
And to close at the High of the Day no less!
Have A Great Weekend Everyone!
Could have been a lot better today, but I'll take a GREEN day any day over Red!
Have A great weekend everyone!
Agree Sid that it is probably a desperation move for Gerald, but what does he have left but to sell out some of the assets and parts of the pipeline in order to fund what I think are the two largest possible producers of income...ESS and ELTO.
That and he needs to bring MANF back to the forefront where his Father wanted from the get go. The fact that WallachBeth was hired to look for avenues told me that a reorganization was underway either by Daddy's direction, or from the Board of Directors finally stepping in and addressing Gerald a little.
A desperation move....Probably. Lets just hope it ends up saving the company!
In My Own Personal Opinion Of Course!
Long AMBS!
I do agree that something is in the works...only wish it would come to surface sooner rather than later.
Asking the TOXICS to hold off till 1/8 was an interesting statement, because it did nothing...maybe the deal fell through, or maybe it is on hold...but not saying anything since leaves us to believe that it is still pending.
I can't see that many huge sells since then except the 60K yesterday afternoon...then today someone is picking up in large quantities.
Pretty baffling to say the least...lets just hope this picture keeps getting painted green, and the MM's and TOXICS will let it ride a little to see if GC does in fact have something up his sleeve.
Best of Luck!
In My Own Personal Opinion Of Course!
Long AMBS!
Not sure I am connecting all the dots either...
May be something in the works to force Roche to buy all the diagnostics instead of just the Cancer test.
If his speaking was the truth, his test is far superior than the one the Roche already owns. Maybe Roche will buy out the company, and in the process issuing more shares to AMBS will force Roche to pay more for the company on a Per share value?
Just a thought.
Roche has paid tons for other companies shares.
After eight months of resistance, Genentech agreed Thursday to a deal in which Roche will pay $95 a share for the 44 percent of Genentech that it does not own.
The new price is higher than the $89 Roche offered in July and a bit higher than its offer last Friday of $93. While Genentech directors initially asked for $112, they came to realize that price was unrealistic in the face of sharply falling world stock markets, according to a regulatory filing by Genentech.
It wouldn't be a surprise if Roche steps in and snags Avant's OvaDx diagnostics test...
it seems that Roche buys anything Cancer related.
Here's to Hoping...
Avant Diagnostics' OvaDx® immuno-oncology diagnostic assay is a protein-based test, potentially representing a significant improvement in the screening and diagnosis for ovarian cancer. OvaDx offers the possibility to make a clear improvement to the current diagnostic standard that generates over $2B in sales annually by substantially improving the accuracy of diagnosis, and allowing for a more effective therapeutic triaging and intervention strategy. Longer term, the assay could become a much-needed early screening tool for all women as part of a standard screening paradigm. It is estimated that the market opportunity for OvaDx is $50M annually as a diagnostic test for ovarian cancer, and this opportunity would expand to over $2B annually if it were to be approved as a generalized screening and/or monitoring tool.
Roche leads $175M investment in oncology software player Flatiron
As part of the deal, Roche has agreed to buy services from Flatiron ... player steps up its life science business development activities, using the base of cancer care data it has built in recent years as a platform for the expansion.
Roche to Buy Majority Stake in Foundation Medicine, Leader in Tumor Testing
The Swiss pharmaceutical giant Roche said on Monday that it would acquire a majority stake in the tumor-testing company Foundation Medicine for more than $1 billion, in a deal aimed at improving both cancer treatment ... not be able to buy all of ...
Roche to buy US cancer drug group Seragon
Roche has agreed to buy Seragon Pharmaceuticals, a privately owned US biotech company, for up to $1.7bn, in a deal that shows the world’s biggest drugmaker by market capitalisation has begun loosening the purse strings on its cash pile.
Roche in $1 billion-plus Foundation Medicine deal to boost cancer efforts The deal will help the world's largest maker of cancer drugs push ahead in developing treatments ... The deal comes fast on the heels of two others. Roche said last month that it would buy Bina Technologies for an undisclosed sum and pay up to $489 …
Roche in $1 billion-plus Foundation Medicine deal to boost cancer efforts
In My Own Personal Opinion Of Course!
Long AMBS!
The More I read, the more I like this Company! Should really start to take off by July!
Intellipharmaceutics Up on Positive Rexista Oxycodone Data
by Zacks Equity Research Published on January 15, 2016 |
Shares of Intellipharmaceutics International Inc. (IPCI - Snapshot Report) surged significantly after the company announced that the bioequivalence trials on Rexista Oxycodone XR extended release tablets have demonstrated bioequivalence to privately held Purdue Pharma’s Oxycontin extended release tablets.
We note that Rexista Oxycodone XR is Intellipharmaceutics’ non-generic extended release formulation for the management of moderate-to-severe pain when an analgesic is required constantly.
Intellipharmaceutics conducted the study as per the design recommended by the FDA and compared the lowest and highest strengths of the exhibit batches of Rexista Oxycodone XR to the same strengths of the reference drug, Oxycontin.
Patients enrolled in the trial were dosed with or without fasting.
In 2015, Intellipharmaceutics announced top-line results from three definitive phase I pharmacokinetic clinical trials on Rexista (single-dose fasting, single-dose steady-state fasting, and single-dose fed), which showed that the drug met all FDA bioequivalence criteria when compared to Oxycontin.
In May 2015, the FDA notified the company upon its Investigational New Drug application submission for Rexista Oxycodone XR that Intellipharmaceutics will not be required to conduct phase III studies if bioequivalence to Oxycontin was demonstrated.
Consequently, the company now plans to complete the regulatory filing requirements and file a New Drug Application (NDA) for Rexista Oxycodone XR with the FDA within the next six months. The NDA will be filed in accordance with the NDA 505(b)(2) regulatory pathway.
Our Take
Results of the trial bode well for Intellipharmaceutics. Since the company is not required to conduct any phase III efficacy trial given positive results from the bioequivalence trials, it will save a lot of time and cost to the company.
Successful development and commercialization of Rexista Oxycodone XR product will be a big boost to the company.
Moreover, the NDA for candidates filed under NDA 505(b)(2) pathway enjoy an exclusivity period upon approval, which, in turn, provides them greater commercial opportunity relative to the generic Abbreviated New Drug Applications (ANDA) pathway.
We remind investors that the FDA has given final approval to the company’s generic version of Focalin XR (dexmethylphenidate hydrochloride extended release in 15-mg and 30-mg strengths).
- See more at: http://www.zacks.com/stock/news/204014/intellipharmaceutics-up-on-positive-rexista-oxycodone-data#sthash.9lbTdKWJ.dpuf
The shareholders keep buying it and increasing the PPS, and the Toxics keep whacking it back down!
75,000 at once.
Up 35%...down 25%...may the day end in Green today!
I sure hope Gerald announces something soon...this is getting ridiculous.
A debt notice would be nice...how much do the TOXICS still hold? the shares have to run out eventually...lets just hope before this gets to a new 52 week low!
In My Own Personal Opinion Of Course!
Long AMBS!
AMBS $$$ ??? $$$
Anything is possible...
http://www.amarantus.com/news/press-releases/detail/2041/amarantus-enters-into-letter-of-intent-to-merge-diagnostics
SAN FRANCISCO and SCOTTSDALE, Arizona, January 19, 2016 /PRNewswire/ --
Amarantus Bioscience Holdings, Inc. (OTCQX:AMBS), a biotechnology company developing products in Regenerative Medicine, Neurology and Orphan diseases, and Avant Diagnostics (OTCQB: AVDX), a medical diagnostic technology company, today announced they have entered into a Letter of Intent (the "LOI") to merge an Amarantus wholly-owned subsidiary, Amarantus Diagnostics, into Avant Diagnostics. Under the terms of the LOI, upon execution of definitive merger agreements, Avant shall issue to Amarantus 80 million shares of common stock of Avant Diagnostics, representing approximately 45% of Avant's post-merger common stock, and 10 million additional shares of common stock upon achievement of certain sales milestones. Amarantus shall have the right to appoint two directors to the Avant Board of Directors, and will assist Avant in bolstering its product development and commercialization resources to accelerate the further development of the combined company's product pipeline. The transaction is expected to be finalized in the second quarter of 2016, and is subject to customary closing conditions.
The proposed merger will create the opportunity to progress highly valuable diagnostic assets in the areas of oncology and neurology. The combined assets have as their common element the potential to provide early and actionable information to physicians and researchers by harnessing the power of biomarkers based in the immune system in disease areas that previously yielded results of limited value. Bringing these assays to market in a standalone diagnostics-focused entity has the potential to improve the practice of medicine by providing new proprietary diagnosis and monitoring tools for oncologists and neurologists:
AMBS $$$ Up 30% TAKE OFF!!!
AMBS and AVDX are Merging Diagnostics...Money to be Made!
30% gain today
http://www.amarantus.com/news/press-releases/detail/2041/amarantus-enters-into-letter-of-intent-to-merge-diagnostics
SAN FRANCISCO and SCOTTSDALE, Arizona, January 19, 2016 /PRNewswire/ --
Amarantus Bioscience Holdings, Inc. (OTCQX:AMBS), a biotechnology company developing products in Regenerative Medicine, Neurology and Orphan diseases, and Avant Diagnostics (OTCQB: AVDX), a medical diagnostic technology company, today announced they have entered into a Letter of Intent (the "LOI") to merge an Amarantus wholly-owned subsidiary, Amarantus Diagnostics, into Avant Diagnostics. Under the terms of the LOI, upon execution of definitive merger agreements, Avant shall issue to Amarantus 80 million shares of common stock of Avant Diagnostics, representing approximately 45% of Avant's post-merger common stock, and 10 million additional shares of common stock upon achievement of certain sales milestones. Amarantus shall have the right to appoint two directors to the Avant Board of Directors, and will assist Avant in bolstering its product development and commercialization resources to accelerate the further development of the combined company's product pipeline. The transaction is expected to be finalized in the second quarter of 2016, and is subject to customary closing conditions.
The proposed merger will create the opportunity to progress highly valuable diagnostic assets in the areas of oncology and neurology. The combined assets have as their common element the potential to provide early and actionable information to physicians and researchers by harnessing the power of biomarkers based in the immune system in disease areas that previously yielded results of limited value. Bringing these assays to market in a standalone diagnostics-focused entity has the potential to improve the practice of medicine by providing new proprietary diagnosis and monitoring tools for oncologists and neurologists:
AMBS $$$ Up 30% TAKE OFF!!!
AMBS and AVDX are Merging Diagnostics...Money to be Made!
30% gain today
http://www.amarantus.com/news/press-releases/detail/2041/amarantus-enters-into-letter-of-intent-to-merge-diagnostics
SAN FRANCISCO and SCOTTSDALE, Arizona, January 19, 2016 /PRNewswire/ --
Amarantus Bioscience Holdings, Inc. (OTCQX:AMBS), a biotechnology company developing products in Regenerative Medicine, Neurology and Orphan diseases, and Avant Diagnostics (OTCQB: AVDX), a medical diagnostic technology company, today announced they have entered into a Letter of Intent (the "LOI") to merge an Amarantus wholly-owned subsidiary, Amarantus Diagnostics, into Avant Diagnostics. Under the terms of the LOI, upon execution of definitive merger agreements, Avant shall issue to Amarantus 80 million shares of common stock of Avant Diagnostics, representing approximately 45% of Avant's post-merger common stock, and 10 million additional shares of common stock upon achievement of certain sales milestones. Amarantus shall have the right to appoint two directors to the Avant Board of Directors, and will assist Avant in bolstering its product development and commercialization resources to accelerate the further development of the combined company's product pipeline. The transaction is expected to be finalized in the second quarter of 2016, and is subject to customary closing conditions.
The proposed merger will create the opportunity to progress highly valuable diagnostic assets in the areas of oncology and neurology. The combined assets have as their common element the potential to provide early and actionable information to physicians and researchers by harnessing the power of biomarkers based in the immune system in disease areas that previously yielded results of limited value. Bringing these assays to market in a standalone diagnostics-focused entity has the potential to improve the practice of medicine by providing new proprietary diagnosis and monitoring tools for oncologists and neurologists:
Trials and tribulations aside, if partnered with AMBS for a Diagnostics division, this will really take off. Most of AMBS diagnostics are already in CLIA approved laboratories, and have been utilized to detect PD and ALZ for other companies to conduct drug trials...only a matter of time before full blown commercialization and into the Testing Market for Hospitals and major Pharma companies...$500+ million market possibilities.
Buying into AVDX is buying into AMBS...look at their boards as well...up 30+%
Great time to buy into both companies and possibly get a 10 Bagger!
In My Own Personal Opinion Of Course!
Long AMBS!
The accumulation is looking good...
Someone is picking up shares.
Stand a chance to make a fortune at these levels if it does in fact become a 10 bagger...
If GC Can take out the TOXICS, this will take off, but that is the 1 Million Dollar Question... does he have the money, or the plan to do so?
Would love to hear that a Big Pharma has dropped in to pick up an asset, or sponsor some research in agreement with exclusivity.
Anything is possible on the OTC!
In My Own Personal Opinion Of Course!
Long AMBS!
I've been dabbling in the Pharma world for a few years now...some good investments, and some not so good. This one looks pretty promising with low share count, and lots of promising irons in the fire. It seems with all the "Behind the scenes" work being done here that any number of catalysts could take the Share Price to well over $10 in a matter of hours. If any big IP comes in and buys up shares, the float will be severely limited and this will really take off.
I'm still reading up on the company, but have take a small stake of $5,000 for now. If I like what I see/read, I will buy more. With a lows near $1.75, and Highs near $4.00 the opportunity to get in and get out quick and make a descent profit along the way are apparent too...but take your chances because if you pull out too early you may miss the train leaving the station when a partner is named with one of the products in the pipeline...
Seems Very Exciting here....
Best Of Luck!
In My Own Personal Opinion Of Course!
Caution the dirty financing deals that the CEO did to get by, and we are still paying the price, but with a Diagnostic deal being spun out, maybe benefits will come in the way of much needed money to get this thing rolling. Been here for a few years watching this go down from the TOXICS.
The pipeline here is good, but the management is terrible.
CEO is son of the lead Doctor/Scientist that discovered the MANF protein. Currently running company into the ground and crushing all the Long shareholders in the process...but maybe a light finally at the end of the tunnel.
Best of Luck!
In My Own Personal Opinion Of Course!
Long AMBS!
That will be EPIC!
New to your board, picked up a couple thousand shares yesterday morning and hoping for the best.
Doog, appreciate all your DD over the past couple months, still getting caught up.
Best of Luck Everyone!
I do believe $1.80 for English translation.
Remember everyone here doesn't speak or write English as a primary language.
In My Own Personal Opinion Of Course!
Is this board still active?
No posts in quite a while...
Just thinking about getting in here?