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arnold

08/22/05 1:14 PM

#22458 RE: bssb #22456

'bssb', Thanks for the update on CYGX's response to your question about why they haven't started human clinical trials for herpes. As CYGX stated that lack of financing was the problem, did they say anything about why they haven't even submitted an IND request almost 9 months after having a pre-IND conversation with the FDA? They could have submitted their request and had everything approved in order to start human clinical trials ASAP after attaining financing. It seems that CYGX is always jumping from one project to another without finishing any...let's hope the DNA lab bears us some "fruit."

Thanks again for passing on what you learned through your DD. Welcome aboard.

Arnold


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neo43

08/23/05 12:29 AM

#22473 RE: bssb #22456

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."