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FCSC - Fibrocell Science Inc

post #1 of 36
10/10/09 at 4:59pm
Thread Starter 
cant find tons of info about this. been seeing on BMR lately

i think their coming out of bankruptcy?

i cant buy thru scottrade because there is no bid or ask

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Fibrocell Science, Inc. Reports Outcome of FDA Advisory Committee Meeting on Azfibrocel-T for Wrinkles
Thursday, 08 October 2009 22:01

EXTON, Pa., Oct. 9 /PRNewswire/ -- Fibrocell Science, Inc. (OTCBB: FCSC) announced today that the U.S. Food and Drug Administration's (FDA) Cellular, Tissue and Gene Therapies Advisory Committee re iewed azfibrocel-T, an autologous cell therapy being investigated for the treatment of moderate to severe nasolabial fold wrinkles in adults. The committee voted 11 yes to 3 no that the data presented on azfibrocel-T demonstrated efficacy, and 6 yes to 8 no that the data demonstrated safety, both for the proposed indication. The FDA is currently evaluating the USAN name, azfibrocel-T, and a proposed brand name, Laviv(TM).

"We will continue to work closely with the FDA following the discussions and recommendations from today's Advisory Committee meeting," said Declan Daly, Fibrocell Science, Inc. interim chief executive officer.

Although it is not binding, the Committee's recommendation will be considered by the FDA as the agency completes its review of the BLA for azfibrocel-T, which was originally filed in March 2009.The FDA is expected to make a decision whether to approve Fibrocell's biologics license application (BLA) for azfibrocel-T by January 4, 2010.

About Fibrocell Science, Inc.

Fibrocell Science, Inc. (OTCBB: FCSC) is a biotechnology company focused on developing regenerative fibroblast cells for aesthetic, medical and scientific applications. Fibrocell Science is committed to advancing the scientific, medical and commercial potential of autologous skin and tissue, as well its innovative cellular processing technology and manufacturing excellence.For additional information, please visit www.fibrocellscience.com.
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post #2 of 36
10/10/09 at 5:08pm
Thread Starter 
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post #3 of 36
10/10/09 at 5:40pm
Looks like they already came out of bankruptcy, changed thier name and got a few new staff members including the senior vice president of GlaxoSmithKline
http://philadelphia.bizjournals.com/..._new_name.html

But looks like no shares have been issued yet, so you cannot buy anything
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post #4 of 36
10/10/09 at 7:07pm
stock-chart-str.aspx?id=FCSC&ca=24062939



Look at the cahrt... Is there even a chart...
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post #5 of 36
10/10/09 at 7:52pm
Thread Starter 
as the guy before me said, shares have not been issued yet . wonder what it will open at when it starts trading . . ill be putting an order in at 0001 lol
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post #6 of 36
10/11/09 at 2:55am
Thread Starter 
guys please read this

something fishy is goin on here lol maybe im missing something

PR from ISOLAGEN (the old company, before bankrupty)

Awash in bad news, Isolagen Inc. had something good to report March 5--data from a successful Phase II/III trial in its personalized medicine therapy for acne, which sent its shares up 31 percent. Isolagen's stock (AMEX:ILE) rose 5 cents to close at 21 cents.The trial of Isolagen Therapy for treating moderate to severe acne scars met all primary efficacy endpoints and was statistically significant. Based on the data, the Exton, Pa.-based company said it plans to file a biologics license application with the FDA within two weeks. But Isolagen also said it has only three weeks of cash left, as it scrambles for financing alternatives, partnerships, and the potential sale of its 57 percent ownership interest in Agera Laboratories. Also looming is a debt liability of approximately $89.7 million related to its 3.5 percent subordinated notes, which could be called due at the option of the note holders as early as ...

recent PR from new company

Fibrocell Science, Inc. Reports Outcome of FDA Advisory Committee Meeting on Azfibrocel-T for Wrinkles

EXTON, Pa., Oct. 9 /PRNewswire/ -- Fibrocell Science, Inc. (OTCBB: FCSC) announced today that the U.S. Food and Drug Administration's (FDA) Cellular, Tissue and Gene Therapies Advisory Committee reviewed azfibrocel-T, an autologous cell therapy being investigated for the treatment of moderate to severe nasolabial fold wrinkles in adults.

supporting article:

To further distance itself from its past financial troubles, the Exton-based company has changed the in-house name of its lead product — formerly known as Isolagen Therapy — to azfibrocel-T.

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ok so we know their talking about the same drug . butttt: the old PR says its for acne and the new PR says its for wrinkles!

am i missing something?
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post #7 of 36
10/11/09 at 2:56am
Thread Starter 
on a better note, the chart of the old company tells that this a perfect candidate to make some good $$. traded on the AMEX and was under 50 cents

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post #8 of 36
10/11/09 at 4:49am
Quote:
Originally Posted by dblo View Post

ok so we know their talking about the same drug . butttt: the old PR says its for acne and the new PR says its for wrinkles!

am i missing something?
Well, they didnt say acne.. they said acne scars, which are two very different things. Wrinkles and scars are results from similar reasons.. and often have very similar or the same treatments... Maybe the drug will be marketed as both an acne scar and wrinkle reducer!

Also, nice find on their previous chart.. after like 4 sites i gave up lol
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post #9 of 36
10/11/09 at 5:29am
Thread Starter 
ok ok . found something else

OLD news:

Phase III clinical trials are underway to evaluate the efficacy and safety of Isolagen Therapy in treating nasolabial folds or wrinkles. A Phase II open-label clinical trial to evaluate the use of Isolagen Therapy to treat fine lines and wrinkles for the full face is also underway.

In addition to wrinkle correction, Isolagen is actively conducting trials in other aesthetic and therapeutic areas including a Phase III clinical program to investigate Isolagen Therapy™ for the treatment of moderate to severe acne scars. Isolagen is planning clinical trials for the treatment of burn scars (Phase II) and is conducting an open label dental papillary insufficiency or tissue loss associated with periodontal disease (Phase II).

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from their OLD website, www.isolagen.com, the cached page on google works.

so its all good . the drug is as u proposed . they made it for wrinkles first it seems then scars.
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post #10 of 36
10/25/09 at 8:34am
Started trading wed. 10/21 .. already up 71%

Shares Outstanding: 38.82M
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post #11 of 36
10/25/09 at 8:50pm
Quote:
Originally Posted by jumpman6235 View Post
Started trading wed. 10/21 .. already up 71%

Shares Outstanding: 38.82M
Yeah, I was trying to keep an eye on this and missed it... The last 10-Q has the O/S around 40 million, but that was under Isogen; the recent 8-K is huge and I couldn't find the current share structure in it anywhere...

Volume/Level 2/Intraday chart play-only for me right now...
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post #12 of 36
10/25/09 at 9:06pm
Thread Starter 
damn . . missed it
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post #13 of 36
10/25/09 at 9:08pm
Thread Starter 
looks like it opened at 1.40
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post #14 of 36
12/8/09 at 6:50pm
Still trading thin, but the FDA date is getting pretty close. Been trying to get in since .80 and NO DICE

"The FDA is expected to make a decision whether to approve Fibrocell's biologics license application (BLA) for azfibrocel-T by January 4, 2010."

"EXTON, Pa., Oct. 9 /PRNewswire/ -- Fibrocell Science, Inc. (OTCBB: FCSC) announced today that the U.S. Food and Drug Administration's (FDA) Cellular, Tissue and Gene Therapies Advisory Committee re iewed azfibrocel-T, an autologous cell therapy being investigated for the treatment of moderate to severe nasolabial fold wrinkles in adults. The committee voted 11 yes to 3 no that the data presented on azfibrocel-T demonstrated efficacy, and 6 yes to 8 no that the data demonstrated safety, both for the proposed indication. The FDA is currently evaluating the USAN name, azfibrocel-T, and a proposed brand name, Laviv(TM)."

http://biomedreports.com/new-latest-...-wrinkles.html
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post #15 of 36
12/16/09 at 9:02pm
Decent volume today 68K; January 4th is right around the corner...
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post #16 of 36
12/23/09 at 4:40pm
Never got in this...luckily...

Fibrocell Science, Inc. Receives FDA Complete Response Letter Regarding azficel-T for Wrinkles

EXTON, Pa., Dec. 21 /PRNewswire-FirstCall/ -- Fibrocell Science, Inc. (OTC Bulletin Board: FCSC) announced today that it has received a Complete Response letter from the U.S. Food and Drug Administration (FDA) related to the Biologics License Application (BLA) for azficel-T, an autologous cell therapy for the treatment of moderate to severe nasolabial fold wrinkles in adults. A Complete Response letter is issued by the FDA's Center for Biologics Evaluation and Research (CBER) when the review of a file is completed and additional data are needed prior to approval. The Complete Response letter requested that Fibrocell Science provide data from a histopathological study on biopsied tissue samples from patients following injection of azficel-T. The letter also requested finalized Chemistry, Manufacturing and Controls (CMC) information regarding the manufacture of azficel-T as follow-up to discussions that occurred during the BLA review period, as well as revised policies and procedures regarding shipping practices, and proposed labeling.

"We are pleased with the review and will work closely with the FDA to complete the histopathology study and provide all of the requested data as quickly as possible," said Declan Daly, Fibrocell Science, Inc. interim chief executive officer.

http://finance.yahoo.com/news/Fibroc....html?x=0&.v=1
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post #17 of 36
12/27/09 at 9:50am
lol.. it barely flinched... i dont think this could have any less interest
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post #18 of 36
1/12/11 at 5:22pm
Fibrocell Science, Inc. Announces FDA Accepts for Review Complete Response Submission for Azficel-T

Press Release Source: Fibrocell Science, Inc. On Wednesday January 12, 2011, 8:00 am EST

EXTON, Pa.--(BUSINESS WIRE)-- Fibrocell Science, Inc. (OTCBB:FCSC.ob - News), a biotechnology company focused on the development of autologous (personalized) cell therapies for aesthetic, medical and scientific applications, announced today that the U.S. Food & Drug Administration (FDA) has accepted for review the Company’s complete response submission for azficel-T, proposed brand name laViv®, for the treatment of moderate to severe nasolabial folds and wrinkles. The Prescription Drug User Fee Act (PDUFA) date is June 22, 2011.



“We are pleased that our complete response was accepted and look forward to working closely with the FDA through the review process,” said David Pernock, Fibrocell Science Chairman and CEO. “If approved, azficel-T will be the first and only personalized cell-based aesthetic treatment.”



The Fibrocell Science scientific approach results in a replenishment of the patient's own fibroblasts, the cells that are responsible for releasing collagen, elastin and hyaluronic acid which add strength and elasticity to the skin. The Company is planning to conduct studies on applying its autologous fibroblast technology in additional areas including further aesthetic applications, and for the treatment of restrictive burn scars, acne scars, and periodontal disease.



About The Fibrocell Science Technology



Fibroblasts are cells that contribute to the formation of connective tissue fibers, and regenerative fibroblast cells may have potential in use for broad aesthetic, medical and scientific applications.



Fibrocell Science’s lead therapy, azficel-T, is an investigational autologous (personalized) cell therapy. In the Fibrocell Science patented process, a patient's own natural fibroblasts are extracted, multiplied and re-injected as personalized therapy to regenerate skin. Azficel-T is currently under review by the U.S. Food & Drug Administration (FDA) for the treatment of moderate to severe nasolabial fold wrinkles. Also, the Company recently submitted a clinical study report to the FDA for a Phase II/III trial of azficel-T in acne scarring.



About Fibrocell Science, Inc.



Fibrocell Science, Inc. (OTCBB:FCSC.ob - News) is a biotechnology company focused on the development of autologous (personalized) cell therapies for aesthetic, medical and scientific applications. Fibrocell Science is committed to advancing the scientific, medical and commercial potential of autologous skin and tissue, as well its innovative cellular processing technology and manufacturing excellence. For additional information, please visit www.fibrocellscience.com.
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post #19 of 36
3/8/11 at 1:03am

FCSC has been getting some attention lately

Its had a nice run the past month or so.. but i think there is still plenty more upside... PDUFA 6/22/2011

 

Here is my DD on it:

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First off, ISOLAGEN did file for bankruptcy, but FIBROCELL SCIENCE is what emerged as the new company because investors saw its HUGE potential and financed it...

 

To sum it up, the FDA had safety concerns (zero efficacy concerns), FCSC did the biopsy study and had great results... this will alleviate all safety concerns... IMO, GREAT chance at approval
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History on Isolagen/Fibrocell
*6/16/2009
"Isolagen (AMEX:ILE) filed for bankruptcy listing debts of more than $88 million and assets of less than $50,000."
Source (http://www.bizjournals.com/philadelphia/stories/2009/06/15/daily16.html)

*9/4/2009
"...bankruptcy judge in Wilmington approved Isolagen’s reorganization plan, which calls for the company to emerge under the name “Fibrocell Science.”
Source (http://www.philly.com/philly/blogs/phillyinc/Out_of_Isolagen_emerged_Fibrocell_Science.html)

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About their lead product azfibrocel-T (laViv)
*10/9/2009
FDA Panel:
The committee voted 11 yes to 3 no that the data presented on azfibrocel-T demonstrated efficacy, and 6 yes to 8 no that the data demonstrated safety,...
Source (http://www.fibrocellscience.com/media/2009/2009_10_09.htm)

*12/21/2009
CRL:
The Complete Response letter requested that Fibrocell Science provide data from a histopathological study on biopsied tissue samples from patients following injection of azficel-T. The letter also requested finalized Chemistry, Manufacturing and Controls (CMC) information regarding the manufacture of azficel-T as follow-up to discussions that occurred during the BLA review period, as well as revised policies and procedures regarding shipping practices, and proposed labeling.
Source (http://www.drugs.com/nda/azficel_t_091222.html)

*12/20/2010
Fibrocell Submits Complete Response to FDA Regarding Azficel-T:
One of the FDA requirements was to conduct a histopathological study examining skin after injections of azficel-T. The Company's response contained data from a 29-patient blinded study (IT-H-001). FDA participated in the design of the protocol, and consented to the unblinding of the study data. At three months, there were no unexpected results, and the study provided additional data to support the safety profile seen in the clinic.
"The study met all expectations and raised no safety concerns."
CEO. "We believe that we have now satisfied all of the FDA requirements."
Source:(http://www.drugs.com/nda/laviv_101220.html)
-Results of the FDA requested Skin biopsy study:
http://www.fibrocellscience.com/investors/pdf/Fibrocell_IT-H-001_Study_web.pdf

*1/12/2011
FDA accepted resubmission and assigned a PDUFA date of 6/22/2011
Source (http://www.drugs.com/nda/laviv_110112.html)

Current and useful info:
Fact Sheet:
http://www.fibrocellscience.com/investors/pdf/FCSC_Fact_Sheet.pdf

Investor Presentation (before/after pics, market cap potential, stats, etc..)
http://www.fibrocellscience.com/investors/pdf/Fibrocell_Investor_Presentation.pdf

11/18/2010: Presentation at Maxim Group Growth Conference:
Wall Street Webcasting - Fibrocell Science, Inc. (http://www.wsw.com/webcast/maxim3/fcsc.ob/)

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**11/3/2010
Fibrocell has a partnership with with Hefei Meifu Bio-Tech Ltd. Co. in China

Under the terms of the agreement, Fibrocell will provide access to its intellectual property, clinical data and manufacturing processes. Meifu will be responsible for all costs associated with construction and operation of a manufacturing facility in Hefei and commercialization, as well as all ongoing operational, research and development expenses.

“We are thrilled to join our scientific and intellectual forces with such an experienced partner as Meifu,” said David Pernock, Fibrocell Science Chairman and CEO. “Our new facility will be built according to the cGMP standards to ensure high quality production and testing. Located in the heart of China, it will provide us with strategic distribution advantages through established market channels. Additionally, we will benefit from rich human resources, low integrated business costs and abundant production resources available in the Hefei area which is known as home to numerous pharmaceutical manufacturers.”
Source (http://www.fibrocellscience.com/media/2010/2010_11_3.htm)
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post #20 of 36
3/15/11 at 8:32pm

Couple of video showing how it works:

 

 

 

 

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