sorry rocky, but you hit one of my pet peeves so I have to point out it's verbiage.

nodope, I will bet a substantial amount that it is not going down tomorrow.

NFY, at this point why wouldn't they save any more news for Friday morning?

In my opinion American Bull is full of bull. They have an interesting algorithm. On the day they confirm a buy recommendation they give themselves credit for having bought at the lowest price the previous trading day. On the day they confirm a sell recommendation they give themselves credit for having sold at the highest price the previous trading day. That provides an advantage that is hard to beat.

Yes, nodope, there is no doubt we certainly all want to make money on ACTC but many of us are, as well, very pleased with the potential ACTC has shown for ameliorating human suffering and improving human life, otherwise we would probably be trying to get in on the latest scam being cooked up by Goldman Sachs (which will probably be more profitable than the best hopes for ACTC even as it destroys another substantial sector of public wealth).

john, did you buy into ACTC after the expiration of the 72 hour disclaimer that accompanied your article?

NYF, for important ACTC partnerships "huge" does not strike me as a necessary or sufficient criteria or even, necessarily, an important criteria, in itself.

nodope, that is precisely why ACTC has positioned itself to move ahead through a number of partnerships in a variety of areas with strong partners (such as already achieved with Roslin Institute) who are able "to build all the labs, staff them, and all the layers of coordination to get these patent processes to market" among many other things.

nodope, this is great general advice for most RSs and FSs but will absolutely miss the boat if ACTC does an RS to move to NASDAQ.

louisa, he did, however, state:

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

To my surprise (having found him not very helpful in the past), I think Dan is correct about what he is saying with respect to protocol for the first stage of the SMD trial (though I still think it could start sooner than he indicates). And Dan is not the only source on this. The ACTC website states the following:


Clinical Trial

Advanced Cell’s trial will start by treating a single patient with an injection of 50,000 cells, Lanza said. If no safety problems are seen, two more patients will receive the same dosage, he said. Subsequent patients will get higher doses to find the most effective safe therapy, Lanza said.

http://www.advancedcell.com/news-and-media/act-in-the-news/advanced-cell-technology-cleared-to-test-stem-cell-therapy-for-vision-loss/


With respect to safety and effectiveness it seems clear that for the FDA safety will be the main and, perhaps, the only official focus but, as Lanza indicates above, ACTC will also be looking at effectiveness.

Dan does, however, confuse the effectiveness (efficacy in his terminology) issue when he says:

"...the first person is evaluated for both the safety and efficacy of the procedure. If the first treatment is deemed both safe and effective, the other dozen or so people will then be treated."

Dan is wrong in this statement about efficacy in the first patient. While ACTC will be looking at both safety and effectiveness, the treatment of the first patient only has to be safe. If it is both safe and effective, so much the better but at the initial 50K dose it doesn't have to be effective, it only has to be safe. As long as it is safe the further trials can go ahead, 2 more patients at 50K and then to the increased doses of 3 patients each at 100K, 150K, and 200K (as long as each escalation also proves to be safe) with the sub-cohort at each level being completed and evaluated before the next higher dose is started. Again, as per Lanza above "If no safety problems are seen....Subsequent patients will get higher doses to find the most effective safe therapy."

I do think ACTC expects to find some effectiveness even in the lower doses.

When Dan says that recruiting can start after all the sites have the IRB approvals, etc., I think he is taking the official line. I think we have seen indications that recruiting has already started in many ways, it just won't be made official with the finalized trial patient cohort until everything is set to go.

I am not sure how to read this statement by Dan:

"Then the first person will be treated, probably mid summer. (ED. note...this could be July before we see the first trial) The recruiting will continue but no one else will be treated for two months while the first person is evaluated for both the safety and efficacy of the procedure."

It is not clear whether the "two months" means the six week trial period followed by two weeks of evaluation or whether it means two months of evaluation after completion of the six week trial. I want to think, and it seems likely that, the former would suffice (and, of course, that would speed things up quite a bit) but I would appreciate other thoughts or knowledge here.

Further comments by Lanza on the SMD trial can be found here:

http://www.independent.co.uk/news/science/stem-cells-could-help-blind-patients-to-see-within-six-weeks-2140301.html

Gastro, the stem cell folks haven't yet directly harnessed neutrinos. CIRM is the word.

Here's a post by ucbawareness from the Yahoo MB on potential ACTC news releases in 2011:

=============================================================

I have compiled a logical series of events for the remainder calendar year 2011 for serious investors to use to gauge the companies progress in correlation to investment value.

1. Receive Patent announcement for Blastomere Program
2. Supreme Court final verdict on funding embryonic stem cell research
3. NIH definition change to include ACT’s “single-ceblastomere” hESC line
4. Announcement of new CEO, CFO
5. Awarding of grants/funds for clinical trials (from corporate slide show)
6. Begin Phase I/II clinical trial for Stargardt’s
7. EMA IND approval to begin Clinical trials for AMD in Europe
8. Begin Phase I/II clinical trial for AMD
9. Possible JV announcement for AMD/Stargardt’s and 200 other retinal diseases (off-label use of RPE cells)
10. ACT and “Roslin Cells LTD” announce new commercialization license for third party academic and commercial entities to utilize patented “single-ceblastomere” hESC Line
11. Update on first 1-3 patients undergoing clinical trials for Stargardt’s
12. Update on first 1-3 patients undergoing clinical trials for AMD
13. Announcement that company was awarded “Fast Track” or “Accelerated Approval” from FDA if treatment shows “superior effectiveness to other available treatments” and “zero side effects”: http://www.fda.gov/forconsumers/byaudien...
14. Announcement of first licensing contract(s) for patented hESC line
15. Clear remaining debt of $900,000 from balance sheet
16. Possible JV announcement for Myoblast Program
17. Receive funding to begin Phase II/clinical trial for Myoblast program
18. Receive IND approval from FDA for Hemangioblast Program
19. Announcement of successful completion of Phase I/II clinical for Stargardt’s/AMD
20. FDA approval for Phase III clinical for Stargardt’s/AMD
21. Possible announcement of Merger/Buyout negotiations (Q4 2011 – Q2 2012)

Good point, Gastro. Could be a couple of years before we get any more news. We'll just have to Hope we get some memorable Superbowl ads, I guess, and some stimulational Posts.

Try accessing them through the company site:

http://www.advancedcell.com/

One of the best moments in the videos from the latest Chairman's Blog takes place in Lanza's comments on ACTC's cellular reprogramming aimed at generating patient specific cells for clinical use. He points out it utilizes cell penetrating peptides that eliminate reliance on viruses or foreign DNA so that no genetic manipulation is needed. He states that ACTC's reprogramming technology and patent filings go back over a decade, long before Yamanaka first reported the generation of iPS cells. He (humbly) sums up by stating that this ability to generate genetically matched cells from a few skin cells is potentially the future of stem cell technology.

The reason for the MCET move into stents?


Is venous stenting really an option for multiple sclerosis?

http://www.cxvascular.com/nn-latest-news/neuro-news---latest-news/is-venous-stenting-really-an-option-for-multiple-sclerosis

Great work here rocky.

Good statement Graeme and although it is true that RPE treatment

"...is not something that can cure every type of blindness."

we should keep in mind that it may also have impact on up to 200 other retinal diseases.

Good info rocky. I didn't know Sepracor had changed names. Is Sunovion a possible ACTC partner in a JV of some kind?

ericshon, though I don't think you are serious here, I will say if you are really all that worried about ACT's lab why don't you make the effort to check it out at their:

Massachusetts Laboratory Facility
33 Locke Dr.
Marlborough, MA 01752

also ask yourself why one of the most often used photographs of a stem cell lab procedure, the classic photo of a single cell being removed from a few days-old embryo, was made at the Advanced Cell Technology lab (scroll to bottom to see photo credits):

http://latimesblogs.latimes.com/booster_shots/2009/11/human-embyronic-stem-cells-stargardts-macular-dystrophy.html

Scorpio on Yahoo MB noticed ACTC sneaking into a report about endothelial cell potential in fighting cancer. Note the caption under the mouse:)

http://articles.latimes.com/2011/jan/21/news/la-heb-rodent-20110121

Blood-vessel cells can combat aggressive tumors: MIT scientists

http://www.kurzweilai.net/blood-vessel-cells-can-combat-aggressive-tumors-mit-scientists?utm_source=KurzweilAI+Daily+Newsletter&utm_campaign=69edd6c695-UA-946742-1&utm_medium=email
-----------------------------------------------



Note and compare to ACTC site info:


-----------------------------------------------
Hemangioblast Cell Program

ACT’s HG program is in preclinical development investigating the possibility of using the cells to treat cardiovascular disease, stroke, and cancer. .......

http://www.advancedcell.com/act-stem-cell-related-research-pipeline/hemangioblast-program/


-----------------------------------------------
Functional Vasculature Generated From Advanced Cell Technologys Human Embryonic Stem Cells

....TC.PK – News) reported that it is feasible to differentiate human embryonic stem cells (hESCs) into functional human vasculature. The research, which appears in the January issue of the journal Regenerative Medicine, shows for the first time that human progenitor cells –known as hemangioblasts– have the potential for both endothelial cell (EC) and vascular smooth muscle cell (SMC) lineage differentiation. .....

http://www.advancedcell.com/news-and-media/press-releases/functional-vasculature-generated-from-advanced-cell-technologys-human-embryonic-stem-cells/


---------------------------------------------------

Rumor says ACTC rally today was kicked off by revelations of how much ACTC staffers are being paid, the resulting conclusion being they must be really good!

Frankly, I would be concerned about ACTC management or any other being cited as smarmy or swarthy but the allegation of "swarmy" says more about the user of the word than anything else.

Good post Investing123. Here's more detail:

++++++++++++++++++++++++++++++++++++++++++++++

Cell and Gene Therapy Forum 2011

Day 1, Focus session 2

eSC's and iPS cells: Separating the hype from the real therapeutic potential

11.45 Chair's introduction

Elona Baum, Esq, General Counsel, California Institute for Regenerative Medicine (CIRM)

Embryonic stem cell therapeutics

Updates on product candidates entering the clinic: What is the latest data, and how are regulatory issues (eg. regarding safety, use of devices, use of genetically-engineered cells) being addressed given the lack of specific guidelines?


12.05 Industry perspective

Human embryonic stem cell-based therapeutics

Spectrum of products under development
Preclinical development approaches to support clinical development
Manufacturing criteria to support clinical trials
Products approaching or in clinical development

Jane S. Lebkowski, PhD, Senior Vice President & Chief Scientific Officer, Regenerative Medicine, Geron Corporation


12.25 Industry perspective

What does it take to get to the clinic?
What are key regulatory considerations?
Approaching the Agency as a partner

Edmund Mickunas, Vice President, Regulatory Affairs, Advanced Cell Technologies (ACT)


12.45 Questions to the speakers & discussion

The Merck news and drop was because of bad results from a study of a promising experimental blood-thinning drug for people who had strokes which analysts pegged as eventually having billions of dollars in annual sales. If that is correct we can imagine what the annual sales would be for the ACTC-Cha JV (SCRMI) blood product.

Some help for evaluating ACTC?

At one point in Maria Bartiromo's interview below Alkermes CEO Richard Pops goes through the valuation of the three corporations represented here, Celgene $30B, Dendreon $6B, and Alkermes $1B and then he says one reason the field is so exciting is:

"You can go from $1B to $6B to $30B on the back of a single drug or two."

Earlier, Dendreon CEO Mitch Gold observed that the latest technology aids companies like Dendreon because smaller companies can now do things that were limited to the largest corporations only 10-15 years ago.

++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++

CEOs on Business of Biotech

The cost of developing a new drug is higher than ever at a whopping $1.3 billion, according to a new study from Tufts University. Celgene CEO Robert Hugin, Dendreon CEO Mitch Gold and Alkermes CEO Richard Pops tell CNBC what this means for the biotech industry.

http://www.cnbc.com/id/15840232?video=1735380838&play=1

Compare prospects of ACTC to stem cell researcher Mesoblast which just made $1.7B licensing deal with Cephalon (ACTC has to be one of the "sleepers" referred to below, and in my opinion ACTC is by far the major one.)

++++++++++++++++++++++++++++++++++++++++++++++++++++++++++

Biotech investors will likely put their portfolios under the microscope after stem cell researcher Mesoblast's unexpected $US1.7 billion licensing deal

Olga Galacho, Herald Sun, Melbourne, January 10, 2011 12:00AM

The Melbourne company, which specialises in bone diseases, recently attracted the bumper investment from US pharmaceutical giant Cephalon, even though it could be two years before it has approval to sell its therapies.

Sector watchers now privately admit they did not pay enough attention to the implications of the milestones Mesoblast achieved and are kicking themselves over the lost opportunity after the stock more than doubled in value.

The coup, masterminded by Mesoblast chief executive Silviu Itescu, will now force investors to determine if there are other sleepers in the biotechnology sector going unnoticed. ......

http://www.heraldsun.com.au/business/biotech-deal-spurs-portfolio-review/story-e6frfh4f-1225984640061

Great work rocky.

I don't know about that Monday morning sell, Gastro. It looks like we now have quite good data on the safety of the hESC-derived RPE cells, they do not form teratomas and/or tumors during the lifetime of NIH III immune-deficient mice and not one Blood Sucker amongst them, either.

nmbr, I stand corrected....it was a misreading of the statement on my part.

nmbr, in your comment here I think you mistakenly flipped the quote you cited in that post. The quote you cite says the hESCs have the genomic duplications and the iPSCs have the genomic deletions, the latter apparently being the more serious problem.

"The train has Stopped at the Station."

Perfect timing for those inclined to get off.

So, after what we have seen for all these years, why didn't ACTC stipulate that the Exercise Price should be based on the "Opening Bid Price?" :)

When rocky cuts and pastes he is often selecting sections from long articles with a lot of material and thereby he brings into focus what he thinks are the most important points. I find that very helpful.

Gastro, I stand corrected, though I must say most short-term traders don't usually consider themselves to be "proud" owners of any stock and generally pride themselves on not having any such feelings. And, in any case, to say "I was a proud owner for a few days." sounds pretty much like an oxymoron to me.

Investing123, and no one is mentioning the possible market for AMD in China, with CHA Bio as a good potential bridge to that. A conservative estimate of AMD in China is 27M and growing fast, as here (and many other areas), because of the aging population in China.

Long-Term Safety and Function of RPE from Human Embryonic
Stem Cells in Preclinical Models of Macular Degeneration

BIN LU,a CHRISTOPHER MALCUIT,b SHAOMEI WANG,a SERGEJ GIRMAN,a PETER FRANCIS,a LINDA LEMIEUX,b ROBERT LANZA,b RAYMOND LUND,a
aCasey Eye Institute, Oregon Health and Science University, Portland, Oregon; bAdvanced Cell Technology,
Worcester, Massachusetts, USA

ABSTRACT

Assessments of safety and efficacy are crucial before human ESC (hESC) therapies can move into the clinic. Two important early potential hESC applications are the use of retinal pigment epithelium (RPE) for the treatment of age-related macular degeneration and Stargardt disease, an untreatable form of macular dystrophy that leads to early-onset blindness. Here we show long-term functional rescue using hESC-derived RPE in both the RCS rat and Elov14 mouse, which are animal models of retinal
degeneration and Stargardt, respectively. Good Manufacturing
Practice-compliant hESC-RPE survived subretinal transplantation in RCS rats for prolonged periods (>220 days). The cells sustained visual function and photoreceptor integrity in a dose-dependent fashion without teratoma formation or untoward pathological reactions. Near-normal functional measurements were recorded at >60 days survival in RCS rats. To further address safety concerns, a Good Laboratory Practice-compliant study was carried out in the NIH III immune-deficient mouse model. Long-term data (spanning the life of the animals)showed no gross or microscopic evidence of teratoma/tumor formation after subretinal hESC-RPE transplantation. These results suggest that hESCs could serve as a potentially safe and inexhaustible source of RPE for the efficacious treatment of a range of retinal degenerative
diseases. STEM CELLS 2009;27:2126–2135

dim, you got into a long line.