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Biotech / Medical : Advanced Viral Research CP (ADVR)
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To: joe blow23 who wrote (2068)1/16/1997 8:55:00 PM
From: s martin   of 2281
 
THE FDA did indeed HALT a study by ADVR according to a press release from the FDA, what is your source of information please?

My question to Dr. Hirschman was:

The rumor is you are building a new facility in Westchester county, NY, how is this facility going to be used ? It was rumored it would be an AIDS clinic, could you explain how "R'" could legally be administered, since the FDA has not approved it and halted human studies, that were started in Miami by the company?

You reply that:<<>>>Again, no news, is good news. It takes considerable effort to open a clinic. "R" can be distributed under the compasionate treatment act (or whatever it's called, someone help me here)and the FDA did not halt human studies, they never granted it, and for good reasons (MANY YEARS AGO!)<<< Statements like this make me wonder where YOU go for information.

"Reticulose AIDS Study Not to Commence Until FDA Approval Is
Obtained"
Business Wire (02/03/95)
Advanced Viral Research announced Friday that on Jan. 27, the
Food and Drug Administration (FDA) instructed the company to HALT
all activities directly related to a pilot AIDS study assessing
the effects of Reticulose on the viral load of people diagnosed
with HIV. The FDA had placed Reticulose on clinical hold with
respect to permitting the drug to be tested on humans. The
company instructed the physicians conducting the study to
immediately stop all related activities. Advanced Viral Research
will now attempt to satisfy the FDA requirements to allow it to
pursue testing of Reticulose on humans. Reticulose is a
non-toxic anti-viral peptide-nucleic acid solution which Advanced
Viral Research believes to be safe and effective against a number
of viral diseases.

Now back to the question to Hirschman.. how can they have a clinc without FDA approval? See?
I'll supply you with more on the FDA halt if I have time. Pretty interesting.
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