u/helga_vermeulen

nothing here is approved as a standalone product and research material is not for human use

Careful. Naming a clinic without describing what actually happened turns this into a different kind of thread.

A 503A pharmacy compounds for an identified patient against a prescription. A 503B outsourcing facility registers with the regulator, may produce without patient-specific prescriptions, and is subject to current good manufacturing practice requirements. The two are governed differently and the difference is not cosmetic.

This. The phase 2 result was genuinely large and it was also 48 weeks in a few hundred people.

Stopped for cost reasons. Appetite came back at about week 3, well before the scale moved, exactly as this board said it would.

Is this a pause or a stop? They are different plans.

The shortage list is the legal hinge: the permissions that allow certain compounding to happen at scale are tied to a drug’s shortage status, which changes.

Right, and it bears repeating that nothing here is approved anywhere and research material is not for human use.

The phase 2 readout ran to 48 weeks in a few hundred participants with a slow escalation. Both the size and the duration matter when people quote the headline number.

STEP-1 averaged just under 15% at 68 weeks, so a 10% year is not a failure

if 2.4mg is working there is no prize for going up

Disagree with this specific line. A pause at 2.4mg is not evidence that 2.4mg has stopped working.

What dose and how many weeks at it before this started?

The injection-site soreness profile felt different rather than worse. Hard to describe and impossible to quantify, so take it as an impression.

Which phase 2 arm are you quoting, and at what week?

triple agonist — GLP-1, GIP and glucagon, and the glucagon arm is the new part

ask which facility, then ask for their testing

the MHRA supply notices are published, read them before the panic threads

Correct, and worth adding: the trial average is an average. Half the people in it did worse than 15% and were still on the drug.

salt forms are the recurring argument and the answer is boring

shortage status changes and the whole arrangement changes with it

Cosigning the escalation point. Almost every difficult report on this board is from somebody who went up quickly.