Out of FCSC at 1.17, 28% profit.
Bought OGXI on the tank, at 21.40 SP
Missed my MSHL exit, will have to wait for another round of news to sell.
Wednesday, December 23, 2009
Updating Portfolio
Sorry all, my laptop went bye-bye last week and I just got my new technology up and running. Apple Air, digging it but it's a slow transition from a PC:)
Tuesday, December 1, 2009
Buying FCSC, Fibrocell Sciences- PDUFA date 1/4/09
This is one I'd written off after watching the VION plummet after their FDA committee meeting, but watching VION have a nice little run these last few days, I am taking a second look at this.
FSCS had an FDA committee meeting on 10/9/09. During that meeting, the majority of the committee basically said the drug was effective but 8 vs. 6 on the committee questioned it's safety. The price rose from .80s to 2.30s on the news and dropped back down. The FDA is due to approve/deny the drug on 1/4/09. Be very careful with this- it's possible the FDA deliver a CRL early and ask the company to do more safety testing.
This has a very low O/S share count- about 14 million, so price can whipsaw quickly. That said, it hasn't been below .60s in quite some time.
I'll be honest, I think the cosmetic surgery stocks can be a gold mine. With longer lives and disposable income, men and women alike are doing more to preserve thier "aesthetics" if you will. What I like about this treatment is that uses the body's own cells vs. synthetic materials.
Fibrocell has a treatment for nasobial fold wrinkles. Right now, there are two primary injections used to treat these wrinkles. They are Juvederm and Restylane (which both use a sythetc substance similar to something naturally found in the body). There are surgical procedures as well.
The Fibrocell procedure uses cells from the patient's own body:
"Fibrocell Therapy is an investigational autologous cell therapy. In the Fibrocell Science patented process, a patient’s own natural fibroblasts are extracted, multiplied and re-injected as personalized therapy. Fibroblasts are cells that contribute to the formation of connective tissue fibers. These matrix fibers are critical to the strength and elasticity of the skin."
The company hopes they can expand the therapy to use in other aesthetic procedures.
FCSC Chart
FCSC Website
Fibrocell Sciences emerged from bankruptcy this year with a new name.
FDA Committee Meeting Results from 10/9/09 were:
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. 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, LavivTM.
Although it is not binding, the Committee's recommendation will be considered by 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.
I bought a position at .85, and have buyins at .65 and .50 as well in case we see a shakeout before the approval date.
Happy researching!
FSCS had an FDA committee meeting on 10/9/09. During that meeting, the majority of the committee basically said the drug was effective but 8 vs. 6 on the committee questioned it's safety. The price rose from .80s to 2.30s on the news and dropped back down. The FDA is due to approve/deny the drug on 1/4/09. Be very careful with this- it's possible the FDA deliver a CRL early and ask the company to do more safety testing.
This has a very low O/S share count- about 14 million, so price can whipsaw quickly. That said, it hasn't been below .60s in quite some time.
I'll be honest, I think the cosmetic surgery stocks can be a gold mine. With longer lives and disposable income, men and women alike are doing more to preserve thier "aesthetics" if you will. What I like about this treatment is that uses the body's own cells vs. synthetic materials.
Fibrocell has a treatment for nasobial fold wrinkles. Right now, there are two primary injections used to treat these wrinkles. They are Juvederm and Restylane (which both use a sythetc substance similar to something naturally found in the body). There are surgical procedures as well.
The Fibrocell procedure uses cells from the patient's own body:
"Fibrocell Therapy is an investigational autologous cell therapy. In the Fibrocell Science patented process, a patient’s own natural fibroblasts are extracted, multiplied and re-injected as personalized therapy. Fibroblasts are cells that contribute to the formation of connective tissue fibers. These matrix fibers are critical to the strength and elasticity of the skin."
The company hopes they can expand the therapy to use in other aesthetic procedures.
FCSC Chart
FCSC Website
Fibrocell Sciences emerged from bankruptcy this year with a new name.
FDA Committee Meeting Results from 10/9/09 were:
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. 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, LavivTM.
Although it is not binding, the Committee's recommendation will be considered by 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.
I bought a position at .85, and have buyins at .65 and .50 as well in case we see a shakeout before the approval date.
Happy researching!
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