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Biotech / Medical : Advanced Viral Research CP (ADVR)

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To: Jack Phillips who wrote (2267)9/30/1997 9:12:00 PM
From: s martin   of 2281
 
The IND was put on hold for one thing, because ADVR refused to give the formula for ADVR to the FDA. The FDA, reasonably, would like to know what the drug they are asked to approve is made of. ADVR thinks it is unfair to have to divulge that information since they have no patent and cannot receive one due to the fact that the drug has been in the public domain for 50 + years.

That is only one of the reasons for the lack of FDA approval, there were many, but ADVR falls back on the reasoning that reticulose should be grandfathered as it was once available to the public. ADVR seems to maintain that it should be approved as it is non toxic (that's in dispute) but the FDA is not willing to approve something because it is non toxic, they would also like some indication that an approved drug is effective in some level. There have been no studies done by any reputable outfit that define that reticulose is effective as a treatment for anything.

Even though reticulose can be obtained under the compassionate use rules, it seems it is not bought and used, which is an indication of it's effectiveness, IMO.
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