Biotech Values

[DewDiligence]

Trends-in-Medicine write-up on ophthalmology endpoints:

[Thanks to Jenkins777 for posting the link.]

http://www.trends-in-medicine.com/Dec2003/FDA-OEndpoints123p.pdf

For AMD, the main point of this write-up is that FDA endpoints are fairly well-defined (compared to, say, cancer endpoints) and they are not in a state of flux.

Some excerpts:

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Macular degeneration: Two year data is needed. “There is some evidence things continue to change for at least two years, so we want all macular degeneration trials going on for at least two years. A sponsor can submit sooner…This is an older population (usually at least 60) and the lifespan of 65-70-year-olds is eight to nine years, so we’ve said a year in their life is an important change. Even if vision is maintained for a year, that is significant, so we are willing to take shorter results -- recognizing that we may say it only worked for a year.”
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The criteria for priority review in ophthalmology is [sic] the same as in other disease areas. A drug does not have to be first-in-class to qualify for priority review. Dr. Chambers explained, “Priority review by definition has to be better than currently existing therapy. A different indication is the easiest (way to gain priority review) because there is nothing to compare to. A broader indication is a different indication. The decision to make grant priority review is made prior to the review of the application. Sometimes we don’t ultimately know if a drug is better before the review, so we may initially review something under priority review, but it may turn out not to be priority.”
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Please note that priority review is not the same thing as Accelerated Approval!