FCSC longs have a curious tendency to post factually erroneous statements. For instance, one recent post says: “If the FDA clears laViv at the end of June, Fibrocell will be entering and expanding the $1 billion annual market in injectable aesthetics.”
According to IMS, the entire worldwide market for dermal fillers in all indications does not amount to as much as $1B.
>You’re going around in circles. As noted in #msg-64138359, the advisory committee rejected laViv on safety, and there are always going to lingering worries about safety when a biologically active cell-based product is used for a cosmetic indication.<
From the: FDA Cellular, Tissue and Gene Therapies Advisory Committee Summary Minutes Meeting #48, October 9, 2009:
> There was general consensus among the Committee that as the product is derived from autologous cells, the risk of tumorgenicity from these cells is low. However, the committee was concerned that insufficient data had been presented on the characterization of the implanted cells to adequately assess the safety of the product. The Committee stated that more information is needed on; the survival and fate of the implanted cells; collagen production by implanted cells; the effect of passage number on the potential for tumorigenicity; the effect of growth-factors and other proteins secreted by implanted cells on the potential for tumorgenicity; and the effect of cell-mediated immune responses. The Committee discussed the need for a greater than 12-month safety follow-up period for patients, including possible follow-up biopsies of implanted site(s). The Committee also briefly discussed other risk factors such as age (greater than 65); genetic predisposition to cancer; heavy smoking.<
This is directly from the advisory committee minutes. They voted 6-8 against 19 months ago (close but no cigar). The committee wanted a greater than 12-month safety follow-up period to see if implanted cells remained productive and there were any other significant safety issues. 19 months have passed and there have not been any significant safety issues.
I am strictly interested in their odds of approval. I think it's better than a 60% bet they get a vote in favor of approval. Better than the lottery but I'd rather play blackjack.
FCSC sold shares five days before its PDUFA date on June 22. This might be an exception, of course, but the track record of companies who do this is not good.
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