Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
NIH Will No Longer Require Special Review for U.S. Gene Therapy Trials
Jocelyn is a staff writer for Science magazine.
Email Jocelyn
By Jocelyn Kaiser Thursday, May 22, 2014 - 4:45pm
In a milestone for the field of gene therapy, the National Institutes of Health (NIH) will no longer subject all proposed gene therapy clinical trials to review by a special federal advisory committee.
“Given the progress in the field, I am confident that the existing regulatory authorities can effectively review most gene transfer protocols and that a streamlined process will reduce duplication and delays in getting gene transfer trials initiated,” said NIH Director Francis Collins in a statement today. Instead, the 40-year-old Recombinant DNA Advisory Committee (RAC) will review only a few trials that pose special risks.
Originally created to review all gene transfer experiments, the RAC in the late 1980s shifted its focus mainly to gene therapy trials. The committee selects about 20% of submitted protocols for discussion at public meetings.
As the field has matured and gene therapy has been used to treat disorders such as inherited blindness and immune deficiencies, researchers have argued that the risks are no different than those of other experimental treatments. They point out that they must already go through reviews by institutional ethics and biosafety boards and the U.S. Food and Drug Administration. RAC review is redundant and slows progress, argued the American Society of Gene & Cell Therapy.
In December 2013, an Institute of Medicine (IOM) panel agreed. It said that although NIH should continue to register trials, the RAC only needs to publicly review protocols that cannot be evaluated by standard oversight bodies and pose unusual risks, for example because they use a new vector. NIH issued a noncommittal response, making it unclear whether it would follow through.
But today, Collins announced that NIH has “decided to accept the IOM committee recommendations on RAC review of gene therapy research.” The agency will soon issue a proposed change to its oversight rules for recombinant DNA research.
Collins’s statement does not address another IOM recommendation, however—that NIH consider replacing the RAC with a similar body that would also review other types of risky clinical research. NIH is still “considering” that recommendation, says spokeswoman Renate Myles.
Posted in Biology, Policy
Share on facebook Share on twitter Share on reddit Share on email
YOU MIGHT ALSO LIKE
Battling Birds Pull Extreme Aerial Maneuvers
U.S. Senate Shelves Long-Debated 'Patent Troll' Bill
Southern sky dims
A lonely crusade
Replication effort provokes praise—and 'bullying' charges
Mice That Feel Less Pain Live Longer
Revised FIRST Bill Would Give Science Agencies 1 Year to Make Papers Free
Democrat Assault on FIRST Bill Delays Vote by House Science Panel
12345678
POPULAR
Most Read Most Commented
Mysterious Illness May Be Carried by the Wind
Lectures Aren't Just Boring, They're Ineffective, Too, Study Finds
Static Electricity Defies Simple Explanation
Cellular Compound May Increase Lifespan Without the Need for Strict Dieting
Ancient Roman Military Camp Unearthed in Eastern Germany
FOLLOW US
Follow Science NOW on Facebook
Follow Science News Twitter
Sign up for Science News emails
Catch the latest Science news with RSS
LATEST NEWS
Biology
Battling Birds Pull Extreme Aerial Maneuvers
Earth
Trillions of Plastic Pieces May Be Trapped in Arctic Ice
Policy
U.S. Senate Shelves Long-Debated 'Patent Troll' Bill
MORE LATEST NEWS
SIFTER
Our favorite stories from around the web
Robotic Crocodiles Watch Hippo Dung
Brain Stimulation Triggers Johnny Cash Obsession
Anchovies Suffocate Off California Coast
MORE FROM SIFTER
SCIENCEINSIDER
Breaking news and analysis from the world of science policy
U.S. Senate Shelves Long-Debated 'Patent Troll' Bill
New Plan for U.S. Particle Physics: Go International
More on the Science of Inequality
Revised FIRST Bill Would Give Science Agencies 1 Year to Make Papers Free
Democrat Assault on FIRST Bill Delays Vote by House Science Panel
MORE FROM SCIENCEINSIDER
© 2014 American Association for the Advancement of Science. All Rights Reserved.
AAAS is a partner of HINARI, AGORA, OARE, PatientInform, CrossRef, and COUNTER.
3D printers to be introduced to classrooms in Britain.
3D printers to be introduced into the classroom in Britain http://t.co/WZyNRf8cZs
— U.S. Army DEVCOM (@usarmy_devcom) October 24, 2013
Didn't they also say in the presentation that they were looking to partner in phase II?
When is the reverse split and up listing suppose to happen? Maybe after that they will announce the data on phase one, up list, then partner for phase II which should drive the pps.
Tiny 3D-printed organs could enable better drug testing
Read more: http://www.foxnews.com/health/2013/09/16/tiny-3d-printed-organs-could-enable-better-drug-testing/?cmpid=cmty_twitter_fn#ixzz2f6uTNbiB
Lanza Voted Top 4 “Most Influential People on Stem Cells”
Lanza featured in the 2013 “TOP 50 Global Stem Cell Influencers.” It is the result of a global survey of the stem cell community, which yielded thousands of votes. The 50 personalities were picked based on their career achievements whether this was groundbreaking discovery and research, innovation, or lifetime dedication. Lanza was among the top four on the list, alongside James Thomson and Nobel laureate Shinya Yamanaka.
Look who Dr. Lantz follows and who he is linked with:
At PCT, we're all about you, our Client. We're committed to cell therapy, our Clients, and their success. PCT is an industry leader in contract development and manufacturing of cell therapy products. With over 12 years of exclusive cell therapy-focused experience, we help our Clients bridge the gap between discovery and patient care through efficient transfer of cell-based therapies from laboratory into clinical practice. In all Client partnerships we place paramount importance on product quality, technical and operational excellence, exceptional customer service, and the protection of Client's proprietary information. We're here to make sure your dream manifests in the real world. LEARN MORE
Cells in Living Mice 'Reprogrammed' to Embryonic-like State
By Rachael Rettner, Senior Writer
Date: 11 September 2013 Time: 01:00 PM ET
New article posted by Dr. Lantz listed above. I couldn't post the actually link because I found it on my linkdin account.
Is that before the split or after? LOL
Lets hope so. Long over due.
That was before they wanted to issue 1 billion shares before a r/s. wtf?
I doubt that very serious!!!! If that were the case I do not think he would have the world best eye institutes supposing his clinic trails! Leave Lantz alone he is brilliant and had earned that respect. He had dedicated his life to this science. Do you SEE clearly or to you have an obstruction in your way?
Rabin on the other hand is a different story that is where the problem lay.
Unless you have something to back up your statement I suggest you post it or shut up! Totally a discredited statement on your behalf! Enough said.....
Agreed
True that!
Maybe until they provide us with some answers we should vote against the authorization and r/s.
Then what will they do?
Ignore the articles they are trying to get cheap shares. Enough said!
A good chance to buy more and average down. Then hold them tight!
I hope so as well. We have to give the APG a chance to turn it around and that takes a little time. I feel confident because they have a stake in the turn around as well and I sure their not in the business to lose money. Or they may turn it around and sell it. I believe those are the options at this time.
Yes, but under status on June 1, 2013 a letter was sent to their attorney, see below remarks.
US Serial Number: 85881275 Application Filing Date: Mar. 20, 2013
Register: Principal
Mark Type: Trademark
Status: A non-final Office action has been sent (issued) to the applicant. This is a letter from the examining attorney requiring additional information and/or making an initial refusal. The applicant must respond to this Office action. To view all documents in this file, click on the Trademark Document Retrieval link at the top of this page.
Status Date: Jul. 01, 2013
I am not trying to sound like a negative nancy just pissed off like everyone else. Sorry to vent on everyone.
I would agree with you. In addition, did Gary say awhile that they were already talking with potential jv about six months or so on one of the conference. It might have even been last December timeframe?
I like to know what happened with that? Also what makes ACTC thinks they can go it alone? No cash? Another 1.0 billion shares! We still have two more phase to prove out where is the cash for that? ACTC needs a lot of money moving forward when do they think it will come from? Let me guess the money tree (shareholders). Very disappointing to say the least!
I have held this stock for five years straight and haven't sold a share. Now I kick myself and wish I would have sold at .27. Dummy me got emotional attached for what I thought was good for man kind. My bad. At this point I will hold what I have till the end. Either I will lose my entire investment in ACTC or see man kind benefit. I guess only time will tell.
Alternative #4 - Assets and Equity
Global Market Capitalization (f) $150 million
Total Assets $75 million
Stockholders' Equity $50 million
Maybe this is why they want another 1.0 billion shares? Just a thought. Thinking out loud.
There are a lot of different scenario for up listing. Just throwing a few around. Thoughts?
That is what I am seeing. Unless I missed something.
Stock Price Criteria
All issuers must have a $4 stock price at the time of listing
Found the requirements for listing at
Domestic listing requirements call for minimum distribution of a company's shares within the United States as well as minimum financial criteria. Distribution of shares can be attained through U.S. public offerings, acquisitions made in the U.S., or by other similar means.
This chart is to be used for an initial evaluation only. For a more complete discussion of the minimum numerical standards applicable to U.S. companies, see Section 102.00 of the Listed Company Manual.
(a) The number of beneficial holders of stock held in "street name" will be considered in addition to the holders of record. The Exchange will make any necessary check of such holdings that are in the name of Exchange member organizations.
(b) In connection with initial public offerings, spin-offs and carve-outs the NYSE will accept an undertaking from the company's underwriter to ensure that the offering will meet or exceed the NYSE's standards.
Distribution & Size Criteria
Must meet all 3 of the following:
Round-lot Holders (a) 400 U.S.
Public Shares (b) 1,100,000 outstanding
Market Value of Public Shares (b,c):
IPOs, Spin-offs, Carve-outs, Affiliates
All Other Listings $40 million
$100 million
Stock Price Criteria
All issuers must have a $4 stock price at the time of listing
Financial Criteria
Must meet 1 of the following standards:
Alternative #1 - Earnings Test
Aggregate pre-tax income for the last 3 years (d) $10 million
Minimum in each of the 2 most recent years
Third year must be positive $2 million
OR
Aggregate pre-tax income for the last 3 years (d) $12 million
Minimum in the most recent year $5 million
Minimum in the next most recent year $2 million
Alternative #2a - Valuation with Cash Flow
Global Market Capitalization (f) $500 million
Revenues (most recent 12-month period) $100 million
Adjusted Cash Flow:
Aggregate for the last 3 years
All 3 years must be positive $25 million
Alternative #2b - Pure Valuation with Revenues
Global Market Capitalization (f) $750 million
Revenues (most recent fiscal year) $75 million
Alternative #3 - Affiliated Company
For new entities with a parent or affiliated company listed on the NYSE
Global Market Capitalization (f) $500 million
Operating History 12 months
Parent or affiliate is a listed company in good standing
Company's parent or affiliated company retains control of the entity or is under common control with the entity
Alternative #4 - Assets and Equity
Global Market Capitalization (f) $150 million
Total Assets $75 million
Stockholders' Equity $50 million
REITs
Stockholders' Equity (b) $60 million
Funds and BDCs
Net Assets (b) $60 million
SPACs
The Exchange will consider on a case-by-case basis, the appropriateness for listing of acquisition companies with no prior operating history that conduct an initial public offering if the following criteria are met:
Proceeds held in trust upon IPO 90%
Fair Market Value of Acquisitions 80% of net assets
Aggregate Market Value $250 million
Market Value of Public Shares $200 million
(c) If a company either has a significant concentration of stock or changing market forces have adversely impacted the public market value of a company that otherwise would qualify for an Exchange listing, such that its public market value is no more than 10 percent below the minimum, the Exchange will consider stockholders' equity of $60 million or $100 million, as applicable, as an alternate measure of size.
(d) Pre-tax income is adjusted for various items as defined in Section 102.01C of the NYSE Listed Company Manual.
(e) Represents net cash provided by operating activities excluding the changes in working capital or in operating assets and liabilities, as adjusted for various items as defined in Section 102.01C of the NYSE Listed Company Manual.
(f) Global market capitalization for already existing public companies is represented by the most recent three months of trading history in the case of Pure Valuation with Revenues. For all other standards, the measurement is "point in time" for existing public companies. For IPOs, spin-offs and carve-outs, it is represented by the valuation of the company as represented by, in the case of a spin-off, the distribution ratio as priced, or, in the case of an IPO/carve-out, the as-priced offering in relation to the total company's capitalization.
Additional Considerations
In addition to meeting the minimum numerical standards listed above, there are other factors which must necessarily be considered. The company must be a going concern or be the successor to a going concern.
The Exchange has broad discretion regarding the listing of a company. The Exchange is committed to list only those companies that are suited for auction market trading and that have attained the status of being eligible for trading on the Exchange. Thus, the Exchange may deny listing or apply additional or more stringent criteria based on any event, condition, or circumstance that makes the listing of the company inadvisable or unwarranted in the opinion of the Exchange. Such determination can be made even if the company meets the standards set forth above.
Domestic listing requirements call for minimum distribution of a company's shares within the United States as well as minimum financial criteria. Distribution of shares can be attained through U.S. public offerings, acquisitions made in the U.S., or by other similar means.
This chart is to be used for an initial evaluation only. For a more complete discussion of the minimum numerical standards applicable to U.S. companies, see Section 102.00 of the Listed Company Manual.
(a) The number of beneficial holders of stock held in "street name" will be considered in addition to the holders of record. The Exchange will make any necessary check of such holdings that are in the name of Exchange member organizations.
(b) In connection with initial public offerings, spin-offs and carve-outs the NYSE will accept an undertaking from the company's underwriter to ensure that the offering will meet or exceed the NYSE's standards.
Distribution & Size Criteria
Must meet all 3 of the following:
Round-lot Holders (a) 400 U.S.
Public Shares (b) 1,100,000 outstanding
Market Value of Public Shares (b,c):
IPOs, Spin-offs, Carve-outs, Affiliates
All Other Listings $40 million
$100 million
Stock Price Criteria
All issuers must have a $4 stock price at the time of listing
Financial Criteria
Must meet 1 of the following standards:
Alternative #1 - Earnings Test
Aggregate pre-tax income for the last 3 years (d) $10 million
Minimum in each of the 2 most recent years
Third year must be positive $2 million
OR
Aggregate pre-tax income for the last 3 years (d) $12 million
Minimum in the most recent year $5 million
Minimum in the next most recent year $2 million
Alternative #2a - Valuation with Cash Flow
Global Market Capitalization (f) $500 million
Revenues (most recent 12-month period) $100 million
Adjusted Cash Flow:
Aggregate for the last 3 years
All 3 years must be positive $25 million
Alternative #2b - Pure Valuation with Revenues
Global Market Capitalization (f) $750 million
Revenues (most recent fiscal year) $75 million
Alternative #3 - Affiliated Company
For new entities with a parent or affiliated company listed on the NYSE
Global Market Capitalization (f) $500 million
Operating History 12 months
Parent or affiliate is a listed company in good standing
Company's parent or affiliated company retains control of the entity or is under common control with the entity
Alternative #4 - Assets and Equity
Global Market Capitalization (f) $150 million
Total Assets $75 million
Stockholders' Equity $50 million
REITs
Stockholders' Equity (b) $60 million
Funds and BDCs
Net Assets (b) $60 million
SPACs
The Exchange will consider on a case-by-case basis, the appropriateness for listing of acquisition companies with no prior operating history that conduct an initial public offering if the following criteria are met:
Proceeds held in trust upon IPO 90%
Fair Market Value of Acquisitions 80% of net assets
Aggregate Market Value $250 million
Market Value of Public Shares $200 million
(c) If a company either has a significant concentration of stock or changing market forces have adversely impacted the public market value of a company that otherwise would qualify for an Exchange listing, such that its public market value is no more than 10 percent below the minimum, the Exchange will consider stockholders' equity of $60 million or $100 million, as applicable, as an alternate measure of size.
(d) Pre-tax income is adjusted for various items as defined in Section 102.01C of the NYSE Listed Company Manual.
(e) Represents net cash provided by operating activities excluding the changes in working capital or in operating assets and liabilities, as adjusted for various items as defined in Section 102.01C of the NYSE Listed Company Manual.
(f) Global market capitalization for already existing public companies is represented by the most recent three months of trading history in the case of Pure Valuation with Revenues. For all other standards, the measurement is "point in time" for existing public companies. For IPOs, spin-offs and carve-outs, it is represented by the valuation of the company as represented by, in the case of a spin-off, the distribution ratio as priced, or, in the case of an IPO/carve-out, the as-priced offering in relation to the total company's capitalization.
Additional Considerations
In addition to meeting the minimum numerical standards listed above, there are other factors which must necessarily be considered. The company must be a going concern or be the successor to a going concern.
The Exchange has broad discretion regarding the listing of a company. The Exchange is committed to list only those companies that are suited for auction market trading and that have attained the status of being eligible for trading on the Exchange. Thus, the Exchange may deny listing or apply additional or more stringent criteria based on any event, condition, or circumstance that makes the listing of the company inadvisable or unwarranted in the opinion of the Exchange. Such determination can be made even if the company meets the standards set forth above.
Domestic listing requirements call for minimum distribution of a company's shares within the United States as well as minimum financial criteria. Distribution of shares can be attained through U.S. public offerings, acquisitions made in the U.S., or by other similar means.
This chart is to be used for an initial evaluation only. For a more complete discussion of the minimum numerical standards applicable to U.S. companies, see Section 102.00 of the Listed Company Manual.
(a) The number of beneficial holders of stock held in "street name" will be considered in addition to the holders of record. The Exchange will make any necessary check of such holdings that are in the name of Exchange member organizations.
(b) In connection with initial public offerings, spin-offs and carve-outs the NYSE will accept an undertaking from the company's underwriter to ensure that the offering will meet or exceed the NYSE's standards.
Distribution & Size Criteria
Must meet all 3 of the following:
Round-lot Holders (a) 400 U.S.
Public Shares (b) 1,100,000 outstanding
Market Value of Public Shares (b,c):
IPOs, Spin-offs, Carve-outs, Affiliates
All Other Listings $40 million
$100 million
Stock Price Criteria
All issuers must have a $4 stock price at the time of listing
Financial Criteria
Must meet 1 of the following standards:
Alternative #1 - Earnings Test
Aggregate pre-tax income for the last 3 years (d) $10 million
Minimum in each of the 2 most recent years
Third year must be positive $2 million
OR
Aggregate pre-tax income for the last 3 years (d) $12 million
Minimum in the most recent year $5 million
Minimum in the next most recent year $2 million
Alternative #2a - Valuation with Cash Flow
Global Market Capitalization (f) $500 million
Revenues (most recent 12-month period) $100 million
Adjusted Cash Flow:
Aggregate for the last 3 years
All 3 years must be positive $25 million
Alternative #2b - Pure Valuation with Revenues
Global Market Capitalization (f) $750 million
Revenues (most recent fiscal year) $75 million
Alternative #3 - Affiliated Company
For new entities with a parent or affiliated company listed on the NYSE
Global Market Capitalization (f) $500 million
Operating History 12 months
Parent or affiliate is a listed company in good standing
Company's parent or affiliated company retains control of the entity or is under common control with the entity
Alternative #4 - Assets and Equity
Global Market Capitalization (f) $150 million
Total Assets $75 million
Stockholders' Equity $50 million
REITs
Stockholders' Equity (b) $60 million
Funds and BDCs
Net Assets (b) $60 million
SPACs
The Exchange will consider on a case-by-case basis, the appropriateness for listing of acquisition companies with no prior operating history that conduct an initial public offering if the following criteria are met:
Proceeds held in trust upon IPO 90%
Fair Market Value of Acquisitions 80% of net assets
Aggregate Market Value $250 million
Market Value of Public Shares $200 million
(c) If a company either has a significant concentration of stock or changing market forces have adversely impacted the public market value of a company that otherwise would qualify for an Exchange listing, such that its public market value is no more than 10 percent below the minimum, the Exchange will consider stockholders' equity of $60 million or $100 million, as applicable, as an alternate measure of size.
(d) Pre-tax income is adjusted for various items as defined in Section 102.01C of the NYSE Listed Company Manual.
(e) Represents net cash provided by operating activities excluding the changes in working capital or in operating assets and liabilities, as adjusted for various items as defined in Section 102.01C of the NYSE Listed Company Manual.
(f) Global market capitalization for already existing public companies is represented by the most recent three months of trading history in the case of Pure Valuation with Revenues. For all other standards, the measurement is "point in time" for existing public companies. For IPOs, spin-offs and carve-outs, it is represented by the valuation of the company as represented by, in the case of a spin-off, the distribution ratio as priced, or, in the case of an IPO/carve-out, the as-priced offering in relation to the total company's capitalization.
Additional Considerations
In addition to meeting the minimum numerical standards listed above, there are other factors which must necessarily be considered. The company must be a going concern or be the successor to a going concern.
The Exchange has broad discretion regarding the listing of a company. The Exchange is committed to list only those companies that are suited for auction market trading and that have attained the status of being eligible for trading on the Exchange. Thus, the Exchange may deny listing or apply additional or more stringent criteria based on any event, condition, or circumstance that makes the listing of the company inadvisable or unwarranted in the opinion of the Exchange. Such determination can be made even if the company meets the standards set forth above.
In order for them to up list don't they still have one case to settle before that? Does this mean that have reached an agreement to settle? What other criteria is there for up listing? Anyone know? Stock had to be above $1.00 I believe?
Great post. Very well said. In regards to Rabin I feel he dealt us the joker.
True! Mostly as I said ACTC will not care but I told them how I felt as a very long time shareholder. I don't like the fact that Rabin couldn't even disclose the additional shares or what the reverse split will be or what the additional shares will be used for! It is time to them to show some transparency to their shareholders!!!
Science yes! But not management or their decision making skills. This really saddened me to think a company like ACTC and the huge potential they have in front of them can only think like the bankers, hedge funds, Wall Street and the other 1% and screw the little guy! Very sad and disappointing to say the least.
I am pissed myself at this whole circus with management. For whatever good it does I sent an email to investor relations and told them exactly how I felt. I am sure they do not care but at least I voiced my opinion. If I get a response i'll post it. But is is highly unlikely.
Thanks for sharing. Most importantly I like the fact that onvo management called them out on it.
Maybe seems to have good communication with the shareholders. I like that!
Yes it is. Very few others doing the same.
Thank you very much for the link. I will start trying to read charts,
However I do not play penny stocks. I was just browsing through the different boards.
Thank you taking the time to respond to my post. I appreciate it.
Thank you. I don't know how to read charts. Sorry.
What do you think about actc?
Is this board mainly penny stocks!
Really why?
Thank you for pointing that out. I didn't realize that was for a new vote. With that being said in sure in the near future they will provide more information. When our the proxies suppose to come out?
Sorry I am new to this board. Couldn't handle yahoo message board anymore. Nuts case over there!!!
I agree they do own the shareholders an explanation. Seeing there was reason indicated for the issuance.
Sorry after I replied to you I seen your email stating you contacted them. Great minds think alike.