"The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint. A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval.
Drug companies are still required to conduct studies to confirm the anticipated clinical benefit. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. If the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market."
"So why can IPIX not utilize the FDA Accelerated Approval Route " As noted earlier the Company would have to identify a "surrogate endpoint" and meet it. The FDA expects a company to run a trial that confirms it. I guess you didn't see it (appears I'm Ignored) but I asked earlier what you would propose that surrogate endpoint might be. Also, would you not expect the FDA to give some thought to and/or require some kind of commitment from the Company to run the required trial and an assurance that funding wouldn't be an issue?
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