This follows post #2 rather than contradicting it. One more thing on compounding permissions that took me far too long to see: the two figures people quote are not measuring the same quantity. Once you notice that, the apparent contradiction disappears.
Asking directly, because I could not find a straight answer: How compounding permissions changed when supply normalised
I was wrong about compounding permissions in a thread last spring and I would like to correct it publicly rather than quietly.
The error was in the units, which changed the conclusion by an order of magnitude. Setting out the corrected version, and the way I now check for that class of mistake.
Everything in the opening post holds. The case it does not cover is the one I have.
An indication approved for one age range does not extend to another, and paediatric extensions are separate decisions with separate evidence.
That holds under the stated conditions and I have stated them.
Generic or biosimilar entry depends on patent and exclusivity positions that are jurisdiction-specific and are frequently misreported.
That has been true for the cases I have seen and I have not seen many.
What I can speak to on compounding permissions is narrow, so I will keep it narrow rather than generalising from it. Beyond that boundary I do not know.
I read post #4 twice before replying, because I had assumed the opposite.
Since compounding permissions keeps coming up, it should probably be a maintained page rather than a recurring thread. I am happy to draft it if someone with more direct experience will review it.
Picking up post #6: that is the part I would want checked first.
If you can confirm or contradict a position for your own region, please date the answer. An undated regional claim is the least useful thing in this category.
A modest claim, modestly supported.
On post #8 — agreed on the reasoning, with one qualification.
The failure mode on compounding permissions is boring rather than dramatic. It is almost always the step everyone assumes was done correctly because it is too simple to get wrong.
Post #7 describes the usual case. This is about the unusual one.
Where a claim about legality is made here, the useful follow-up is which instrument it rests on. Most such claims turn out to rest on a forum post.
I would put this at better than even and not much better.
Fine by me. I had wanted a stronger conclusion and there is not one available.
An honest declaration on compounding permissions: I have a prior here and it is strong enough that you should weight what I say downward. Stating it rather than hiding it.
Having read the whole compounding permissions thread before replying: the question in the first post has not actually been answered yet, and three of us have answered a nearby one instead.
Small methodological point on compounding permissions: repeating a measurement is cheap and resolves most of what is being argued about here at no cost to anyone.
Generic or biosimilar entry depends on patent and exclusivity positions that are jurisdiction-specific and are frequently misreported.
That is the version I would defend. It is not the version I started with.
Adding a null result on compounding permissions. I looked, carefully, and found nothing, and null results deserve posting precisely because they never are.
If you can confirm or contradict a position for your own region, please date the answer. An undated regional claim is the least useful thing in this category.
Adding what did not work for me on compounding permissions, since the failures never get written up and they are half the useful information.
That is consistent with mine, for whatever one more account is worth.
Two sentences on compounding permissions and then I will stop, because the rest is speculation and the thread is better without mine.
What is documented is narrow. What is inferred from it is broad. The gap between them is where every argument here lives.
Where a claim about legality is made here, the useful follow-up is which instrument it rests on. Most such claims turn out to rest on a forum post.
Taking post #25 at face value and following it one step further.
Compounding permissions: I would want to see the raw numbers rather than the summary before agreeing. Summaries lose exactly the information that would settle this.
Nothing in this subcategory is legal advice, and the members who work in regulated environments are the most careful to say so.
It is one reading of the data and not the only reasonable one.