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Re: bssb post# 22456

Tuesday, 08/23/2005 12:29:38 AM

Tuesday, August 23, 2005 12:29:38 AM

Post# of 64738
bssb, someone was pulling your leg . . .

or maybe you misunderstood what you were told (I'd hate to think they lied to you).

Before those clinical trials they're allegedly ready for can begin, an IND application must be submitted to the FDA and approved. But in the update issued a few weeks ago, the company says the following:

"Herpes/Simplivir: primary vendors and back-ups have been identified, experimental protocols defined and budgets prepared for studies needed to complete the IND application to the FDA. These include:
- Bio-distribution studies;
- GLP Toxicology;
- DNA drug substance determination; and
- Definition of SIMPLIVIR as a drug product.

"Vendor selection and project initiation await funding."

In other words, due to their lack of funding, they haven't even started the studies that must be completed and submitted to the FDA with the IND application.

That certainly doesn't seem to me like being "ready for the first clinical trial of herpes cream."

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