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Why's of NewFill FDA BAN
Dec 10, 2001

I asked BioTech for information on the "why's" of the FDA ban. This is what they sent back. (The anser is 3/4 the way down). -Jeff P.S. Thank you for you service to the HIV community with this forum.

BIOTECH INDUSTRY SUMS UP THE USE OF NEW-FILL FOR LIPOATROPHIES

1. NEW-FILL for lipoatrophies in Europ New-Fill has obtained its official recognition in November 1999 for its use in Cosmetic.Since february 2000, several clinical trials have been made in France, England Holland and Switzerland. The first clinical trial of "La Salptrire Hospital" in Paris is finished; Professor Katlama has just published in October 2001, at the Congress of Athens. Youll find enclosed this scientific publication; the Patients injected for this study will be examinated for 2 years, till October 2002 to show the effects of New-Fill during a long period. At the end of this study, Biotech Industry will send the results the Medicine Agency, in France, to try to hace a repayment for the Patients VIH. Meanwhile, many Hospitals train Doctors to inject these Patients.

2. NEW-FILL in USA and Canada For the moment, nothing has been done with FDA. Many american Patients want to be injected and send Biotech Industry mails. Several possibilities: * Patients from USA come to Europ to be injected in Paris, London or Belgium. * Patients are injected in USA or Canada. In USA some Doctors have been trained by Doctor Elisabeth Laugier- Laglenne who has in part invented the product , and made the clinical trials of La Salptrire Hospital and some of them had been authorized by the FDA to inject New-Fill. * Doctors buy New-Fill through our mexican distributor who has the authorization to export the kits to USA. * Doctors buy New-Fill at our address in Luxemburg.

BIOTECH INDUSTRY is a small structure, not a multinational Company Several american groups are interested by the product, but we havent made a decision to begin the clinical trials for USA. *** !!! *** Weve been informed by a Doctor of New-York who injects a lot of New-Fill and who has been trained in France, that there are problems with FDA certainly because a Doctor in USA has made advertising about New-Fill, which is unacceptable. Every day, many Patients and Doctors send Biotech Industry mails; they want to buy New-Fill and look for addresses.

We think it would be useful and comforting to combine strengh through Associations, Hospitals , Doctors, Patients...to help us. Our e-mail is: new-fill@internet.lu Thank you.

Doctor Elisabeth Laugier-Laglenne Michle Derviso

Response from Dr. Fisher

Thanks for sending this along. Hope this is helpful to others. AF


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