Calzada’s fat-buster drug AOD9604 declared ‘safe’

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DonsRule

DonsRule

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Good news everybody

http://www.theaustralian.com.au/bus...04-declared-safe/story-e6frg9lo-1227008477408
Calzada’s fat-buster drug AOD9604 declared ‘safe’
  • JULY 31, 2014 11:43AM
Tim Boreham

Criterion Columnist
Melbourne
https://plus.google.com/116956110402704936193
CALZADA (CZD, 12c) subsidiary Metabolic Pharmaceuticals’ contentious fat-busting compound AOD9604 has been officially decreed as safe — though not to the reputations of the Essendon and Cronulla football clubs.

US authorities have given Generally Recognised as Safe (GRAS) status for AOD9604 to be included in foods and dietary supplements, at a per capita maximum level of one milligram a day.

Like so many biotech announcements, this one’s not entirely new in that conditional approval was bestowed in June 2012.

All Calzada needed to do was to have its previous studied peer-reviewed in a scientific journal, but like Criterion on deadline, the company prevaricated.

The formal approval opens the first major channel of legal usage for AOD9604, which to date has been the domain of body builders obtaining knock-off stuff from dubious channels.

Calzada chairman David Williams says GRAS status “might make Metabolic’s intellectual property an attractive target for supplement, ingredient and nutraceutical companies’’.

Helpfully, he reels off a list of possible parties who might want to buy or license the rights to AOD9604.

These include Abbot, GSK Consumer Health, Nestle, Proctor & Gamble, PepsiCo and Red Bull.

Of course the drugs-in-sport watchdogs WADA and ASADA — which have banned the substance at least partly on safety grounds — will be watching with interest.
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http://www.theaustralian.com.au/bus...04-declared-safe/story-e6frg9lo-1227008477408
 
Phfft. US Authorities are just Essendon fan boys, nobody takes them seriously.
 

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DonsRule said:
Good news everybody

http://www.theaustralian.com.au/bus...04-declared-safe/story-e6frg9lo-1227008477408


http://www.theaustralian.com.au/bus...04-declared-safe/story-e6frg9lo-1227008477408
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I don't think you, or the other Essendon posters understand this announcement. Nor it seems the journalist who wrote the article.

There are plenty of compounds that are in supplements that turn out to be unsafe, in fact, this method of sale is often the workaround for companies looking to market compounds of dubious safety and or benefit because it does not require any of the stages of rigorous FDA approval (which drugs require).

To be clear, AOD9604 cannot be sold as a drug and hasn't passed any of those stages of FDA screening. The certification allows an entry level to the dietary supplements market (or as a food additive, but why), and requires virtually no/minimal burden of proof as to a compounds safety, nor efficacy, in this case only requiring Calzada's pre-existing material, so would not allay any overarching safety concerns.
 
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don't some of the pharmaceuticals have some 2.1 billion put away to cover the damage their previously declared safe diet pills did.
 

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DivideandMultiply said:
I don't think you, or the other Essendon posters understand this announcement. Nor it seems the journalist who wrote the article.

There are plenty of compounds that are in supplements that turn out to be unsafe, in fact, this method of sale is often the workaround for companies looking to market compounds of dubious safety and or benefit because it does not require any of the stages of rigorous FDA approval (which drugs require).

To be clear, AOD9604 cannot be sold as a drug and hasn't passed any of those stages of FDA screening, this allows an entry level to the dietary supplements market (or as a food additive, but why?), which requires virtually no/minimal burden of proof as to a compounds safety, nor efficacy, in this case only requiring Calzada's pre-existing material, so would not allay any overarching safety concerns.
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Good post. And not only this, but there are drugs and supplements coming out all the time whose effects are unknown over the short and long terms. Isn't that the point of S0? So if something turns out to be fine and WADA says you can inject as much as you want, use it then. Until that happens, it's banned under S0 and if you use it you're in strife. Essendon has dodged a bullet on AOD - not sure why they're so keen to crow about it.
 
Nothing new here, it's easier to get GRAS status as a food/dietary supplement, than it is to get photo ID.
tassiedog said:
Does this mean WADA will back date its not allowed status?
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http://www.washingtonpost.com/blogs...-possibly-dangerous-ingredients-in-your-food/

Food manufacturers are routinely exploiting a “legal loophole” that allows them to use new chemicals in their products, based on their own safety studies, without ever notifying the Food and Drug Administration, according to a new report by an environmental and consumer advocacy group.
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http://www.washingtonpost.com/blogs...-possibly-dangerous-ingredients-in-your-food/

This has been going on for yonks, basically to get GRAS status, you apply, and have the option of signing off on the safety of your own product, the FDA box ticks and you move on. The option, which most businesses take, is supplying in house documentation, which can be as simple as recorded data, in house "expert opinion" and non peer reviewed papers.
 
philohk said:
Good post. And not only this, but there are drugs and supplements coming out all the time whose effects are unknown over the short and long terms. Isn't that the point of S0? So if something turns out to be fine and WADA says you can inject as much as you want, use it then. Until that happens, it's banned under S0 and if you use it you're in strife. Essendon has dodged a bullet on AOD - not sure why they're so keen to crow about it.
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sorry where are Essendon "crowing" about it?
 
So does that mean James will put the profits he got from the human trials on his players back into the club?
 
AndyLucimitis said:
I get confused - is this is the drug that gives me the permanent suntan or the permanent woody ?
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No No No you are confused. This like all the rest of the drugs the players may or may not have taken it has ABSOLUTELY NO BENEFIT AT ALL!

Certainly not performance enhancing and certainly of no use for a fully fit athlete.

Why else would you take experimental drugs or cancer medicines or immune suppressants or whatever(it takes)?

This is a big win for the EFC :confused:
 
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