Eli Lily 's Latest Scheme

[Danger1212]

How boring am I? I panic bought paper towels and heated bidets.

I think my best panic buy was that bidet and the water pick from Costco!

 

[Jerrey]

Rice and beans and canned foods and bird pellets Then my job got classified as essential anyway. I had customers tipping me in rolls of toilet paper and a bunch of us stole the gigantic rolls from the store restrooms.

Interstate rest stops being burglarized for their stock of TP became a common occurrence.

 

[tubby]

I personally hope Lilly gets the result they want on this. I'll explain:

If they can't get the classification they want, they still need to stop compounding pharmacies from selling their drug, and they're not going to stop going until that happens. That means they'll get a new law passed that says compounding pharmacies can keep "making" their stuff, but can only source API from the manufacturer at retail price and will likely crush any other exceptions peptides have now that we might enjoy.

And if that doesn't work for some reason then they'll just start making their newer GLP products into much more complicated structures (that gray market labs will struggle to properly produce) to achieve the biologics designation.

I "hate" pharma as much as the next guy, but wanting them to be unable to enforce their patents is short-sighted.

 

[Ragnar]

According to the standardized methods of classification retatrutide is a synthetic peptide that is 39 amino acids. It should be clear cut case for the courts to reject Lilys claim based on the current law that Biologics are defined as 40 amino acids. Courts don’t always like to follow laws as they are written so I wouldn’t be surprised if Lily somehow convinces a judge to interpret it as 40 amino acids.

As far as a crackdown on gray market peptides, I think that AI will continue to play a role in this. The other meaningful way would be changing laws so that peptides can’t be sold to lay people for “research use only”. I hope this doesn’t happen but the fear makes me consider increasing my 2 year supply.

 

[tncc_rn]

My understanding is if the FDA says you need 8 legs to be a spider ( a biologic) and you show up with your 7 leg creature- ok cool but it just ain’t an 8 legged spider.

All just to get a longer patent window. Have to admire them and their 7 legged thing, I have one, I got him from China and he hella cute.

The Comprehensive Methamphetamine Control Act of 1996

Good luck with "analogs". DEA closed that door decades ago....

Don't ask how I know....

 

[tncc_rn]

According to the standardized methods of classification retatrutide is a synthetic peptide that is 39 amino acids. It should be clear cut case for the courts to reject Lilys claim based on the current law that Biologics are defined as 40 amino acids. Courts don’t always like to follow laws as they are written so I wouldn’t be surprised if Lily somehow convinces a judge to interpret it as 40 amino acids.

As far as a crackdown on gray market peptides, I think that AI will continue to play a role in this. The other meaningful way would be changing laws so that peptides can’t be sold to lay people for “research use only”. I hope this doesn’t happen but the fear makes me consider increasing my 2 year supply.

This may be the only thing that keeps Peptides from being reclassified as Biologics. But don't put it past the government to "rewrite" a law if their pockets get lined deep enough by Big Pharma.....

 

[homebrew]

According to the standardized methods of classification retatrutide is a synthetic peptide that is 39 amino acids. It should be clear cut case for the courts to reject Lilys claim based on the current law that Biologics are defined as 40 amino acids. Courts don’t always like to follow laws as they are written so I wouldn’t be surprised if Lily somehow convinces a judge to interpret it as 40 amino acids.

As far as a crackdown on gray market peptides, I think that AI will continue to play a role in this. The other meaningful way would be changing laws so that peptides can’t be sold to lay people for “research use only”. I hope this doesn’t happen but the fear makes me consider increasing my 2 year supply.

40 amino acids is not in the statute. The threshold was adopted through guidance, not formal rule making. Lilly is counting it as 41 amino acids (39 plus two other chains). The FDA called it 40 amino acids, accepting one but not both chains without the required case by case analysis. The judge rejected the FDA classification as "arbitrary and capricious" and sent it back to be re-accessed.

 

[HereKittyKitty]

Rice and beans and canned foods and bird pellets Then my job got classified as essential anyway. I had customers tipping me in rolls of toilet paper and a bunch of us stole the gigantic rolls from the store restrooms.

That's called rationing, not stealing.

 

[tncc_rn]

40 amino acids is not in the statute. The threshold was adopted through guidance, not formal rule making. Lilly is counting it as 41 amino acids (39 plus two other chains). The FDA called it 40 amino acids, accepting one but not both chains without the required case by case analysis. The judge rejected the FDA classification as "arbitrary and capricious" and sent it back to be re-accessed.

Oof....guidance. Ask any gun owner about ATF "guidance" letters from the Tech Branch. Nightmare for trying to follow "the rules"....

 

[Ragnar]

40 amino acids is not in the statute. The threshold was adopted through guidance, not formal rule making. Lilly is counting it as 41 amino acids (39 plus two other chains). The FDA called it 40 amino acids, accepting one but not both chains without the required case by case analysis. The judge rejected the FDA classification as "arbitrary and capricious" and sent it back to be re-accessed.

https://www.wsgr.com/en/insights/fda-releases-final-guidance-transition-of-previously-approved-drugs-to-being-deemed-licensed-biologics.html

My understanding is based on The Biologics Price Competition and Innovation Act (BPCIA) of 2009, and the Further Consolidated Appropriations Act, 2020 as described in this article. The following is a direct copy that lead to my interpretation.

Has the determination of which proteins can qualify as biologics changed?

Yes. The BPCIA defined a biologic (biologic product) to include a "protein (except any chemically synthesized polypeptide) …" Further, earlier FDA final guidance clarified that a protein is "any alpha amino acid polymer with a specific defined sequence that is greater than 40 amino acids in size." Thus, initially, for a protein to be a biologic, it had to: 1) be greater than 40 amino acids in size; and 2) not be chemically synthesized. The Further Consolidated Appropriations Act, 2020, removes the chemically synthesized exclusion, thereby potentially increasing the number of proteins that can become biologics.

It’s possible I’m missing something amongst all the lawyer talk but I interpret this to mean that based on this definition that retatrutide is not greater than 40 amino acids regardless of how Lily argues it or how a judge rules it.

 

[HereKittyKitty]

Absolutely. During RFK Jr.'s congressional hearings, he mentioned "inspecting" China's warehouses (under the guise of safety inspections). This is going to get interesting.

Hes just looking for his side hustle for when he loses his job. Grifter.

 

[HereKittyKitty]

According to the standardized methods of classification retatrutide is a synthetic peptide that is 39 amino acids. It should be clear cut case for the courts to reject Lilys claim based on the current law that Biologics are defined as 40 amino acids. Courts don’t always like to follow laws as they are written so I wouldn’t be surprised if Lily somehow convinces a judge to interpret it as 40 amino acids.

As far as a crackdown on gray market peptides, I think that AI will continue to play a role in this. The other meaningful way would be changing laws so that peptides can’t be sold to lay people for “research use only”. I hope this doesn’t happen but the fear makes me consider increasing my 2 year supply.

There is already talk of classifying as PUO and doing away with RUO.

 

[BNLFL]

This makes me want to order as many kits as I can afford. The greed of Big pharma.

I've already started, and will continue. I don't trust them all. Almost as powerful as oil companies, and possibly more. Look at that kung foo China BS. This is just my thinking. The stuff will not go to waste.

Panic buying Peptides reminds me of COVID times when we would panic buy ammunition, primers, powder, and whatever else we could think of.

They were the best of times and they were the worst of times…

Have you stocked up yet?

 

[Ragnar]

1-/q

There is already talk of classifying as PUO and doing away with RUO.

I hadn’t heard this but sounds interesting. i understand ruo is research use only. What is puo?

 

[NBA_MiddleAgedGirl]

Hes just looking for his side hustle for when he loses his job. Grifter.

Strong agree! Hopefully he is on the list of people being fired soon! I think he’s on the outs.

 

[Danger1212]

I've already started, and will continue. I don't trust them all. Almost as powerful as oil companies, and possibly more. Look at that kung foo China BS. This is just my thinking. The stuff will not go to waste.

Have you stocked up yet?

Yeah, I have, and also couple GBs I’m waiting for; including the one you couldn’t tell me about because of my banner status

Dunno what I’m going to do with R140 by myself but i have a decade to think about it

 

[deluge]

I think my best panic buy was that bidet and the water pick from Costco!

Please tell me you aren't using both, uh, at the same time?

 

[BNLFL]

Dunno what I’m going to do with R140 by myself but i have a decade to think about it

I think I have mine figured out, and might recon and blast one vial for kicks. I have a little ways to go for my goal, but I keep lower it based on the belly and side fat areas.

 

[Danger1212]

I think I have mine figured out, and might recon and blast one vial for kicks. I have a little ways to go for my goal, but I keep lower it based on the belly and side fat areas.

Please, do tell me your idea!

I already see my post 1 month from now after reconstituting my R140:

Need Help - RS on 14mg of Reta and Hungry

 

[MikeyMike]

Absolutely. During RFK Jr.'s congressional hearings, he mentioned "inspecting" China's warehouses (under the guise of safety inspections). This is going to get interesting.

I couldn't see China agreeing to inspections.