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Dan T.

Any Change - Bio-Alcamid Status in U.S.?

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Has the FDA moved forward at all in the review of Bio-Alcamid in the U.S.?

Anyone know the status? Have any time-frames been established?

Dan

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Hey Dan,

As far as I'm aware, there aren't even any FDA approved clinical studies for bioalcamid or aquamid. So it could be a while, literally years, before it gets approved in the US. You could call A-Lo (ms. anna love) down at Clinic Estetica in Tiujuna. She seems to be leading the cause to get BA approved in the US though her integrity is something to be questioned IMO. Nothing about bioalcamid on the FDA site. Heard internet rumors that

Polymekon, the company that manufactures bioalcamid, only approached the FDA around this time last year to

begin the process. It's been really quiet since then...no news at all about it. Word has it there are all sorts of problems with BA for acne scarring, but I think these problems are mainly related to overinjection and improper injection (not in the Sub-Q layer of the skin as it should be) and NOT related to the biochemical safety of the substance. Perhaps there will be a push to get it approved in the US for lipodistrophy soon and will be available for off label use for scarring someday.

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Has the FDA moved forward at all in the review of Bio-Alcamid in the U.S.?

Anyone know the status? Have any time-frames been established?

Dan

You don't want to try it, believe me, unless you have big and well-defined depressions on your face. I'll never touch it again.

JL

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Dan, I'm not trying to sabotage your thread but I was wondering about the same about isolagen. I thought this was supposed to be approved some time early last year? Anyone know anything? Thanks.

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Thanks Kooky for the very thorough reply.

Jenny - sounds like you had a bad experience. What happened with BA.

Dan

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