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Hi Adam,
Is it true that the FDA requires a drug treat a specific disease? I do believe it, but do you have a reference for that? Thanks a lot!

Good question. The article says:
"There is no Food and Drug Administration category for longevity drugs, so if the company is to submit a drug for approval, it needs to be for a specific disease."

Offhand, though, I don't know the specific laws or regulations that support the claim. I also don't know what if anything justifies the view that aging has not or cannot be considered a disease. Anyone know?

Hi Adam & ns,

I am not sure I have a direct answer to your question regarding a legal reference that they must target a specific disease but let me see if I can add some insight. Resveratrol being the main base of the SRT501 drug by Sirtris they are "most likely" going the FDA route for credibility purposes. To get this FDA approval they need to do studies (or trials) on a "specific" disease in order to measure it's effectiveness on humans. Unfortunately, there is no way to test the effects of longevity on humans without it taking 25, 50, or over 100 years. So the process of proving longevity is very difficult if not impossible. So doing trials on longevity is a mute point at this time.

This leaves them with other options: do trials for specific diseases linked to longevity and living life healthier into old age. Such as type II diabetes, certain cancers, and heart disease. Something most people didn't catch was that recently Sirtris filed for "Orphan Drug Status" to treat MELAS syndrome. It's a very rare disease that effects few people in the world. Since Sirtris is willing to do these trials the FDA gives them a fast tracking status which greatly shortens the time it takes to get a drug approved.

This is where it gets a bit hairy for me regarding legalities... Once a drug is approved for any disease I believe a Doctor has a right to prescribe the drug for other reasons as they feel may be necessary. So if it gets approved you could have docs prescribing this drug for "life extension" and diabetes perhaps. I am sure those with more knoweledge on the legalities can respond to that.

As for SRT501 just being a resveratrol supplement then if it weren't for credibility I am not sure why they wouldn't just bring it to market.

They also mention another drug that Sirtris is trying to bring to market and is in early stage trials for. They are called NCEs or "New Chemical Entities) These are synthetic chemicals which MUST be approved by the FDA unlike a natural supplement.

Hope this helps a bit,

Markus
http://www.myresveratrolexperience.com

Very interesting info, Markus. Thanks!

This is where it gets a bit hairy for me regarding legalities... Once a drug is approved for any disease I believe a Doctor has a right to prescribe the drug for other reasons as they feel may be necessary. So if it gets approved you could have docs prescribing this drug for "life extension" and diabetes perhaps. I am sure those with more knoweledge on the legalities can respond to that.

Hi Adam,

I know it's been a while since this was posted but recently some new information came to light about the subject. It seems as though some of our assumptions were correct about Sirtris' SRT501 and that monetizing the product would perhaps be a bit difficult.

They are putting more focus on their NCE's (New Chemical Entity), more specifically SRT2104, which is not a form of resveratrol but is said to have 1000 times the potency of resveratrol. I believe it is a more synthetic drug that focuses on activating the SIRT1 gene in humans. They are supposed to be entering Phase 2 trials some time next year.

I recently made a post about it on my blog which you can find here:

http://www.myresveratrolexperience.com/2008/11/sirtris-makes-major-moves-goes-relatively-unreported.html

A link to the original article from xconomy.com is also referenced in the post if you would like to check it out. I found the statements by the CEO very interesting in respect to how they should focus on these new products.

Hope all is well,

Markus

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