3,465 karma · joined November 28, 2013
>So if they are not getting it from producers under license from NN, where are they getting it?
They're obtaining it from pharma labs with the right equipment and talent to produce it. The synthesis process is well understood, it's not like it's a Novo Nordisk secret.
> Why isn't the legality of that path under active legal attack?
It is.
For one, the FDA does not 'license' any manufacturer, period. They do enforce safety and quality standards, but this is not controlled through some sort of a general license, and operates on a per-facility basis.
DMF listing (which isn't a 'license') does not necessarily have any relation to whether that manufacturer is supplying a brand name provider.
The 'license' that account is posting about a complete fiction. There is not a license granted here in any government context, nor a license between NN and the manufacturers the post discusses.
> The compounders are legally selling the real thing directly to customers.
This is debatable. They are not selling 'OEM' NN product to consumers.
Also - stop talking about 'feedstock'. It's weird. It's not standard industry lingo and obscures whatever the hell it is you're talking about (precursors? lyophilized product? something else?)
In practice, there are generic manufacturers for semaglutide, and many other peptides still protected by US patents, mostly located in China. The more reputable of these manufacturers produce these drugs at levels of purity rivaling the 'name brand'. These manufacturers export lyophilized product en masse to middlemen that operate in the grey/black-market 'research chemical' sales market, or ship to compounding pharmacies. The consumers purchasing on the grey/black market reconstitute the drug at home (which requires a trivial level of effort), and assume some extra degree of risk in terms of product purity and sterility. Consumers wanting an extra level of assurance for product quality purchase from a compounding pharmacy that ostensibly is conducting its own assessments of product purity, and following best practices for sterile reconstitution.
Caveat emptor. Falcon and other similar security products often push updates at-will, and they're fully transparent about this if you actually read the contract terms and understand the vendor's approach to operations. I have worked with many clients that elect not to use such tools in certain sensitive environments, specifically to mitigate the risk of being impacted by something like CrowdStrike's 7/19 event.
Unfortunately the buttons are purely for aesthetics.
HEB (the major player in the Texas market) is a notable exception that has true vertical integration, with in-house manufacturing and packaging facilities producing house brands, and its own direct relationship with raw goods/farm suppliers.
They more or less killed the original model, but they're pushing to deploy the new 'Vertica' model so that drip coffee is brewed on-demand rather than by batch. Ostensibly to reduce waste.
The output from Vertica machines is definitely subpar compared to the original, however.
SAMU's program is impressive and shows a lot of promise as a bridge treatment, and it's completely unlike anything available here in the US today (where myself and the friend I mentioned earlier live).
Reading the newspaper is a 'maybe' here, but the notion of patients just generally walking around while on ECMO treatment as we know it today is absurd. Letting a patient be ambulatory during ECMO treatment is still in the realm of very, very, very small-n clinical trials, and the risk of near-immediate death from things like a cannula dislodging are very high. Even if it was safe, you're looking at a massive cart of equipment and 1-2 dedicated personnel to walk around with the patient while tweaking its settings.
In general, nobody being treated by ECMO is 'reading the newspaper', if they're cogent and conscious at all. It has absolutely brutal effects on the body, and people are kept sedated while receieving the treatment for good reason.
Thankfully most vendors or their marketing agency affiliates that engage in this sort of thing aren't particularly clever about it, so identification of puppet accounts to ban isn't too difficult.