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Re: None

Friday, 03/31/2006 2:05:01 PM

Friday, March 31, 2006 2:05:01 PM

Post# of 146235
The only question I have is whether or not each subsequent change in the targeting protein will mean a large enough change that the FDA will require safety testing and approval. One assumes that a pass on FluCide means a pass on AviFluCide and vice versa, but does that also apply to different virus strains? Would HiviCide require simple efficacy studies or would they require rigorous repeat testing of Phases I, II and III? Once FDA approval is met for the underlying, or base, micelle, shouldn't the timeline for each application (HIV, cancer, hepetitus, rabies, etc) be greatly shortened? Expansion of product line and market will be greatly dependent upon how the FDA interprets and applies its current rules regarding polymeric micelle technology.

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