It appears the EU Orphan designation is approved, compliments of Rikker
from ICELL
http://investorstemcell.com/forum/advanced-cell-technology/3613.htm

7th from bottom
EU/3/11/874
Human embryonic stem-cell-derived retinal pigment epithelial cells
Treatment of Stargardt’s disease
TMC Pharma Services Ltd
21/06/2011
http://investorstemcell.com/forum/advanced-cell-technology/3613.htm

elk and ford,

I don't think the delivery method has changed from this. Same application as the mice and rats as far as I know..

"Finally, the mechanism of application is a needle. Unlike most appliance applicators, it does NOT have to be approved by the FDA. A needle is recognized by the FDA as a standard mechanism of application and even more importantly every eye surgeon utilizes a needle in surgical procedures dealing with the eye. Therefore, you don’t have to teach the “old dog new tricks” which is a huge barrier when normally introducing new therapies utilizing a delivery device. "
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=41946204

ford,

to my knowledge, the device is a needle. Maybe on this order.
http://www.dorc.nl/products.php?group=18143,18144,18163,18194&product=113134&view=product

I have no procedural links but ACT is suppose to be putting some info out prior to start from what I have heard from others.

elk,

That means the first injections could already have taken place.

possible, imo has not.

interstate,


The patients have to be on an immune suppress for 2 weeks prior to injection.

From SHM,

Kathy Singh:
Ok. Will the company announce when the first injection takes place?

Gary Rabin:
Of course. We are trying to be quite transparent here. As I told you, we are working with UCLA to finalize who the first two patients are this Friday and we probably try to announce that we selected those patients sometime in the following week or early week after, and we start them on a course of immune suppression for a week and then we’ll do the injections. So, I am sure as you can imagine, there will be plenty of publicity around what is happening with this.
http://investorstemcell.com/forum/advanced-cell-technology/3092.htm

StockWizard22


From JHam;
http://investorstemcell.com/forum/advanced-cell-technology/3091.htm

Conference Call Highlight Summary.
Hey everyone! I listened once again to the conference call this morning and took down some notes. I thought I would post some of the main highlights of the call to make it easier.

SMD/AMD Trials

- Gary on the upcoming trials, "Absolutely transformative trials in the history of regenerative medicine"

- Two patients (one for SMD and one for AMD) were to have been selected yesterday, Friday June 10th

- Selection of patients will be announced next week or the week after

- After selected, patients will begin one week of immunosuppressants followed by RPE injections thereafter

- Gary said the company WILL announce when the injections have taken place and added, " I'm sure as you can imagine, there will be plenty of publicity around what 's happening in this"

- According to Johnson & Johnson, in terms of dollar value, AMD is the #1 most unmet medical need in the world

- ACT will announce two other sites besides Jules Stein and Casey Institute

- ACT will be releasing preliminary trial results by early October

- If Phase I trials are going better that expected, ACT may seek to terminate the trial so that they can shift to a more "pivotal trial immediately"

- Dr. Lanza said the attachment of the RPE cells to the Bruchs Membrane is not a concern

Before end of 2nd Qt.

- Finalizing patients

- Starting SMD/AMD trials

- EMA approval (could happen early 3rd Qt.)

2nd half of this year

- File IND for Myopic Retinopathy

Other Programs

- IND for Hemangioblast (hopefully) to be filed in the next 12 months

- Myoblast will be partnered out to a third party. Gary said they are making great progress with this and to look for more info in the near future

Europe

- EMA has informed ACT that the review process of the CTA for SMD has begun

- Gary will meet with the EMA in July to find out what they need to get trials underway in EU

- ACT is "absolutely seeking compassionate use" for SMD. Depending on CTA approval in EU, ACT could see compassionate use by the end of 2012, but more likely 2013

- Patent issue in EU. Statements in front of EU courts proclaim it is required to destroy embryo. Attorney General has now been made aware by ACT that there are alternative methods to extract a cell without embryo destruction. He was unaware of this at the time the statements were issued to the court. EU countries may decide to go about this issue independently. UK is very Pro-Stem cell research so trials will probably start there

Miscellaneous

- ACT should have agreement inked with Roslin in the next few weeks. However Matt Vincent implied it would be much sooner, "tomorrow"

- ACT will be applying for October CIRM grant. Gary has met with the CIRM President

- ACT is working on a video that will explain everything the public needs to know about the upcoming trials

China/India

- Gary speaking about hiring other C level staff: "...but once you get outside the science and into the operational and the financial operations of the company, and the logistics of day to day running a company with operations not only in the U.S., but Europe, Korea, and hopefully soon doing things in China and India, you know obviously it is quite overwhelming"


Administration

- Lanza will renew his contract which is set to expire at the end of September. "I'm not going anywhere" stated Lanza

- Gary Rabin has been trying to create a culture of more openness and transparency with shareholders

- The search is very active to find more C level staff. ACT hired global executive search firm Spencer Stuart 3 months ago to help in finding a Chariman, CEO, CFO, CBO. So far thrilled with two candidates with a third visiting Marlborough soon

Here is the Appelate Courts Decision,


http://www.courtinfo.ca.gov/opinions/documents/A129336.PDF

It appears ACT will NOT be getting their attorney fees. The 3 Judge panel affirmed what the lower court ruled. Respondent(Aronson) goes back to trial court in August to recover costs..

06/21/2011 Opinion filed. (Signed Published)
The order denying attorney fees is affirmed. Respondents shall recover their costs on appeal.
http://appellatecases.courtinfo.ca.gov/search/case/dockets.cfm?dist=1&doc_id=1951955&doc_no=A129336

Remittitur issued. 08/22/2011
http://appellatecases.courtinfo.ca.gov/search/case/scheduledActions.cfm?dist=1&doc_id=1951955&doc_no=A129336

remittitur:
A document issued at the end of an appeal that returns jurisdiction to the trial court.

employed by ACT? you got to be kidding me. It's call research and DD, I have been doing it a long time. What "timely" info has you dreaming?

Chairmans Blog June 20, 2011

Time Magazine Features ACT’s Clinical Trials For Macular Degeneration

Greetings,

As you are no doubt aware, last Thursday, June 16th, we announced that the first patients have been enrolled at the Jules Stein Eye Institute at the University of California, Los Angeles (UCLA) for our two upcoming Phase 1/2 clinical trials using using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs) for Stargardt’s Macular Dystrophy (SMD) and Dry Age-Related Macular Degeneration (Dry
AMD).

We are very pleased about achieving this milestone and see it not only as an important step forward for ACT, but for the overall field of regenerative medicine.

The announcement was greeted with enthusiastic coverage from the news media. This included coverage from newswire services such as Reuters and Europe’s AFP, as well as major newspapers such as the Washington Post’s “Checkup” blog, the Guardian (UK), and elsewhere.

The feature article in the TIME magazine’s print and online edition is particularly gratifying. The story, by senior reporter Alice Park, appears in the current issue, dated June 27, now available on newsstands nationwide.

Among other aspects of the two clinical trials, the TIME story discusses the involvement of Steven Schwartz, M.D., principal investigator of the trials at UCLA, Ahmanson Professor of Ophthalmology at the David Geffen School of Medicine at UCLA, and retina division chief at the Jules Stein Eye Institute.

The story also quotes Robert Lanza, M.D., our chief scientific officer, as saying, “We are finally ready to break ground on this field with the first trials. It’s taken a decade of extensive research to get to this point.”

Please find the article on TIME’s website via the following link:

http://www.time.com/time/magazine/article/0,9171,2078130,00.html

Thank you.

Gary Rabin
Interim Chairman and CEO
Advanced Cell Technology, Inc.
http://www.thechairmansblog.com/gary-rabin/

Todays S-8,

For me, the good news is that from April 29(10Q) to May 31,(S-8) only an additional 2MM shares have been issued for a toral of 1.545B.. Prior to the CD payoff end of 2010 ACT was running about 30-40MM shares issued
per month. The "share spicket" has been turned way way down which is one of the items I was most interested in seeing...Excellent, so far.

interstate,


They can be issued at will for the following reasons:

"to continue to be able to attract, retain and motivate executive officers and other employees and certain consultants. Upon stockholder approval, additional shares of Common Stock will be reserved for issuance under the 2005 Stock Plan, which will enable us to continue to grant equity awards to our officers, employees and consultants at levels determined by the Compensation Committee to be necessary to attract, retain and motivate the individuals who will be critical to the Company's success in achieving its business objectives and thereby creating greater value for all our stockholders"

Todays S-8 filing,


Increase the authorized under 2005 Stock Plan by approx. 72MM shares
for the following reason.

(per Stock Plan)
"(b) The number of shares of Common Stock available for issuance under the Plan shall automatically increase on the first day of each of the Company's fiscal years beginning in 2008 equal to 5% of the Shares outstanding on the last day of the immediately preceding fiscal year".

This is exactly how the authorized shares in 2005 Stoick Plan is increasing. Number of shares at year end were 1,439,826,362 multiplied by 5% gives us the additional 71,991,318 registered in S-8 today.

The change has taken place, the old cusip was deleted and the new one went in place(effective date) on May 9,2011.

CUSIP #'s,



05/09/2011
DELETE 21839P107 CBAI CORD BLOOD AMERICA INC XNAS

ADD 21839P206 CBAID CORD BLOOD AMER INC NEW COM STK (CA) XNAS

http://www.dtcc.com/downloads/legal/imp_notices/2011/nscc/otc/OTC-088.PDF

and I agree. The point of my exchange with you was based on the following statement you made..

"I think the blog entry was pretty fair and balanced, but again failed to mention the single-blastomere technology (even though it's not being used for this trial)."

Example of commercial license ACT had with WARF,

A. License Fee.

In consideration of the rights granted under this Agreement, Licensee agrees to pay to WARF a license fee of Six Hundred Thousand Dollars ($600,000) (the “Initial License Fee”) in accordance with the payment schedule set forth herein this Section 4; provided, however, Licensee shall be entitled to a credit in the amount of Two Hundred Twenty Five Thousand Dollars ($225,000) representing the license fees paid to WARF by Licensee as required under the Research Agreement. Licensee shall pay to WARF the Initial License Fee in twelve (12) installments of $31,250 each. The installments shall be due on a quarterly basis as follows:

B. Royalty.

Licensee also agrees to pay to WARF as “earned royalties” a royalty of (i) four percent (4.0%) of the Net Selling Price of Therapeutic Products, and (ii) two percent (2.0%) of the Net Selling Price of Diagnostic Products and Research Products, sold or transferred under this Agreement. The royalty is deemed earned as of the earlier of the date the Licensed Product is actually sold, leased or otherwise transferred for consideration, the date an invoice is sent by Licensee, or the date a Licensed Product is transferred to a third party for any promotional reasons. Licensee acknowledges and agrees that the royalty paid hereunder is provided as additional consideration for the rights afforded under the Research Agreement which led to the discovery and/or development of the Licensed Products to be commercialized under this Agreement. Licensee is required to pay only one royalty with respect to a Licensed Product regardless of the number of patents or patent applications included within the Licensed Patents whose claims cover that Licensed Product.
http://www.sec.gov/Archives/edgar/data/1140098/000110465907062594/a07-18956_1ex10d1.htm

commercialization licenses and milestone payments would be a part of revenues, possibly a big part.

ACT has provided contract specifics on everything to date that I am aware of, not sure why this deal would be any different. The Roslin PR has already provided some detail although that can change.

Predictability in price and commercialization terms is a key feature of the goals of the collaboration. Roslin Cells will promote access to the hESC lines from the bank as research reagents to both academic and commercial entities. In addition, ACT and Roslin Cells will publish a commercialization license so that third parties will have a reasonable and predictable path to commercialization of products using the same hESC lines that they may use in animal model studies for preclinical data. Commercialization licenses will also provide access to the cell lines biologics master file in order to establish regulatory compliance. Proceeds from commercialization licenses, including milestone and royalty payments, will be shared between ACT and Roslin Cells.
http://www.advancedcell.com/news-and-media/press-releases/advanced-cell-technology-and-the-roslin-institute-announce-agreement-for-storage-and-distribution-of-/index.asp

Hopefully the following will assist some regarding recent questions:

(page 4 of Proxy)
May 10, 2011. On such date, 1,542,957,661 shares of Common Stock were outstanding
(155K shares less than the 10Q showed, not sure why)

Using 1.53B as OS#(a month old now) and adding " in the money options and warrants" we can arrive at a fully diluted count.

(From 10Q)

Warrants: 107MM in the money with exercise price of .10-.11

Options: vested and exercisable and in the money now approx. 20MM

Fully diluted using Treasury Method of in the money warrants and options.............1.657 B shares

Authorized share # is 1.750 B

Recent discussions of "shares available in 2005 Incentive Plan" is 127MM
Socius $21MM funding line

Summary: Without any large amounts of Stock Plan shares being issued and no Socius dollars drawn upon
(no need to do so right now) and based upon the " share faucet" being turned down considerably since the payoff
of CD financing, it seems ACT, imo, is good until approx year end without addressing Authorized increase or
restructuring in some form.

Spetty,


80% of the blog you are referring to was about the ACT trials, 10% about Geron and 10% about the ethical dilemma which in the case of our trials using MA09 apllies, right? So why on earth bring up the fact in a trial update article like that about the non destruction process? To me, it is akin to throwing gas on a fire. If ACT doesn't lead on the issue why should some reporter with limited knowledge try and explain?..

Spetty,


but again failed to mention the single-blastomere technology (even though it's not being used for this trial).

If some of these reporters were up to speed, which many are not, would it be better to have them say something like the following?

(example)
ACTC has patented single blastomere technology that does NOT harm the embryo. The upcoming trials will be using a single blastomere derived hESC line, MA09, which did NOT preserve the embryo.

My point, I am hoping updated news of trials and the no destructiion process stay seperated unless ACT educates via their own PR's. I haven't gone back to look at all clinical trial updates but "single blastomere" is not a part of the lingo but rather ..."using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs).....I suspect for the same reason I am trying to make...thanks

fwiw, I have asked I-HUB admin to remove this post as it appears the information in article was not correct...I normally double check these things and did not and paid the price..sorry for any inconvenience...
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=64280686

hmitwatch,

I really have no answer for that. Concerning prior article on CHA approval from KFDA, Rabin is stating that article is incorrect so so hang in there until it is verified one way or the other...thanks.

flyasif,

From SHM,

Kathy Singh:
Ok. Will the company announce when the first injection takes place?

Gary Rabin:
Of course. We are trying to be quite transparent here. As I told you, we are working with UCLA to finalize who the first two patients are this Friday and we probably try to announce that we selected those patients sometime in the following week or early week after, and we start them on a course of immune suppression for a week and then we’ll do the injections. So, I am sure as you can imagine, there will be plenty of publicity around what is happening with this.
http://investorstemcell.com/forum/advanced-cell-technology/3092.htm

Spetty,

from SHM,

Kathy Singh:
Alright. Will we have interim status reports and at what milestones – two weeks, six weeks?

Gary Rabin:
As I said before, after we gotten data from the first patient in each trial, that data will be submitted to the data management safety board. They will review the data and then we’ll treat patients 2 and 3 in each trial. And then within about 6 weeks after that, we hope to be able to publish something. So we probably talking about sometime in the October timeframe to publish information about how trials are going.
http://investorstemcell.com/forum/advanced-cell-technology/3092.htm

feeed,



what is the difference between the link you posted and the audio found at ACT home page under info below that I e-mailed you?..thanks

EVENTS

Thursday, June 9, 9:30AM PDT
ACT Annual Shareholders Meeting
Click here to listen to recording.

From JHam;
http://investorstemcell.com/forum/advanced-cell-technology/3091.htm

Conference Call Highlight Summary.
Hey everyone! I listened once again to the conference call this morning and took down some notes. I thought I would post some of the main highlights of the call to make it easier.

SMD/AMD Trials

- Gary on the upcoming trials, "Absolutely transformative trials in the history of regenerative medicine"

- Two patients (one for SMD and one for AMD) were to have been selected yesterday, Friday June 10th

- Selection of patients will be announced next week or the week after

- After selected, patients will begin one week of immunosuppressants followed by RPE injections thereafter

- Gary said the company WILL announce when the injections have taken place and added, " I'm sure as you can imagine, there will be plenty of publicity around what 's happening in this"

- According to Johnson & Johnson, in terms of dollar value, AMD is the #1 most unmet medical need in the world

- ACT will announce two other sites besides Jules Stein and Casey Institute

- ACT will be releasing preliminary trial results by early October

- If Phase I trials are going better that expected, ACT may seek to terminate the trial so that they can shift to a more "pivotal trial immediately"

- Dr. Lanza said the attachment of the RPE cells to the Bruchs Membrane is not a concern

Before end of 2nd Qt.

- Finalizing patients

- Starting SMD/AMD trials

- EMA approval (could happen early 3rd Qt.)

2nd half of this year

- File IND for Myopic Retinopathy

Other Programs

- IND for Hemangioblast (hopefully) to be filed in the next 12 months

- Myoblast will be partnered out to a third party. Gary said they are making great progress with this and to look for more info in the near future

Europe

- EMA has informed ACT that the review process of the CTA for SMD has begun

- Gary will meet with the EMA in July to find out what they need to get trials underway in EU

- ACT is "absolutely seeking compassionate use" for SMD. Depending on CTA approval in EU, ACT could see compassionate use by the end of 2012, but more likely 2013

- Patent issue in EU. Statements in front of EU courts proclaim it is required to destroy embryo. Attorney General has now been made aware by ACT that there are alternative methods to extract a cell without embryo destruction. He was unaware of this at the time the statements were issued to the court. EU countries may decide to go about this issue independently. UK is very Pro-Stem cell research so trials will probably start there

Miscellaneous

- ACT should have agreement inked with Roslin in the next few weeks. However Matt Vincent implied it would be much sooner, "tomorrow"

- ACT will be applying for October CIRM grant. Gary has met with the CIRM President

- ACT is working on a video that will explain everything the public needs to know about the upcoming trials

China/India

- Gary speaking about hiring other C level staff: "...but once you get outside the science and into the operational and the financial operations of the company, and the logistics of day to day running a company with operations not only in the U.S., but Europe, Korea, and hopefully soon doing things in China and India, you know obviously it is quite overwhelming"


Administration

- Lanza will renew his contract which is set to expire at the end of September. "I'm not going anywhere" stated Lanza

- Gary Rabin has been trying to create a culture of more openness and transparency with shareholders

- The search is very active to find more C level staff. ACT hired global executive search firm Spencer Stuart 3 months ago to help in finding a Chariman, CEO, CFO, CBO. So far thrilled with two candidates with a third visiting Marlborough soon

Look what can happen Identa,

Washington, D.C., June 7, 2011 — The Securities and Exchange Commission today suspended trading in 17 microcap stocks because of questions about the adequacy and accuracy of publicly available information about the companies, which trade in the over-the-counter (OTC) market.

George Canellos, Director of the SEC’s New York Regional Office, added, “The investing public does not have accurate or adequate information about these securities to use in making informed investment decisions

SEC Suspends Trading in 17 Companies in Proactive Effort to Combat Microcap Stock Fraud
http://www.sec.gov/news/press/2011/2011-120.htm

exactly bball, well stated...eom

There will be selling pressure all the way, not sure I am understanding? Once again, the 18.5MM Lanza shares sold over a period of time will not be a major road block by any stretch. If you feel it will be, that's fine, I respect your opinion.

or ACT could have volume of 1.2 Billion shares like last DEC? With both trials in the loop maybe volume will once again be much different than what you state?...who knows
http://www.otcbb.com/asp/tradeact_mv.asp?SearchBy=issue&Issue=ACTC&SortBy=volume&Month=12-1-2010&IMAGE1.x=25&IMAGE1.y=2

http://finance.yahoo.com/q/hp?s=ACTC.OB&a=11&b=1&c=2010&d=11&e=31&f=2010&g=d

18.5MM shares sold over a period of time doesn't amount to a hill of beans when you have a float of 1.5 Billion shares..

what does todays 8K have to do with a potential uplist?..thanks

8K..eom

Karin,



well said, I wouldn't consider holding physical certs even if it was a blue chip, but that is just me..

bsm,


no, I am not invested and never have been. I have some stock friends who are so I pop in here and there..

Agent,


holding physical certs? What will you do if you need to sell quickly for some reason?
http://www.sec.gov/investor/pubs/holdsec.htm

north,


further clarification, ACT currently has no IND's filed here in the US, therefore no HOLDS on IND's at this point. If any holds take place now it will be PHASE 1/2 type thing, not IND's. ACT does have a CTA(like US IND)
filed with EU as of April,2011.
http://www.advancedcell.com/news-and-media/press-releases/act-files-european-clinical-trial-application-for-phase-12-study-using-embryonic-stem-cells-to-treat-/index.asp

north,


that article I posted explaining the NIH redefinition is 15 months old. Sorry for not indicating such.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=4695066

FWIW, Both IND's were cleared and both Stargardts and dryAMD trials are posted and getting ready to proceed with patient injections.
http://clinicaltrials.gov/ct2/results?term=%22Advanced+Cell+Technology%22