Preliminary simulations [BE/BA News]

posted by ElMaestro  – Denmark, 2022-04-30 19:10 (16 d 00:49 ago) – Posting: # 22946
Views: 352

Hi Hötzi,

your post is potentially highly significant.

» Is this really the intention? The wider the range in tmax, the more easily products will pass. Counterintuitive.

The intention, as I understand it, was exactly the opposite. It goes completely against all intention, doesn't it?
I think this knowledge, if it holds in confirmatory simulations, should be published quickly and made available to regulators.

I very much hope that regulators will abstain completely from letting pride prevail over the regard for the EU patient. So I hope they will not dismiss the argumentation. For example, I could fear they would dismiss your findings because they don't have a palate for simulations (but note they like simulations well enough when it comes to f2; bootstrapping is a simulation, too).

Pass or fail!

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