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BonelessCat

01/19/10 4:07 PM

#26907 RE: mkendra #26902

What would be the FDA time expectation for a topical ointment or eye drop? With the urgency of new HIV antivirals growing, what could we expect for a fast-track following the tox package? 2 to 3 years? Less?

FDA approval of the BioDefense drugs? Forgetaboutit. Those government folk work at their own pace. But, the cash for development is enormous and if the drug gets added to the stockpile it means tens of millions in revenue without a concern for a sort of marketing partner. So, the timing to revenue is not necessarily tied to FDA approval and commercialization.