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I think incompetent is harsh, but they had a bad data submission and also a dosing error. Neither is a good look. Neither ended up being a big problem but they
by ethanbond 6y ago
I think incompetent is harsh, but they had a bad data submission and also a dosing error. Neither is a good look. Neither ended up being a big problem but they could’ve been.
- hef19898 6y agoYeah, that was an issue. I cannot tell how much of an issue, because I have zero experience with medical trials. As do most people, I assume, getting upset about that. Regardless, AZ got approval in the UK and from EMA in the EU. And these entities job is clinical trial assessment. Unless I am going to refuse any and all drugs and medical treatment, I will have to trust e.g. EMA that the stuff I take when being sick is safe and working as intended.
- peytn 6y agoI’ve got a little bit of FDA experience, but of course no COVID-19 EUA experience. Based on what we submitted to the FDA and the comments we received, I would personally think it most likely there were many issues with AZ’s materials, at least as far as their attempts to seek approval from the FDA went.
- ethanbond 6y agoA good heuristic for how big/rare of a problem would be to try to find another instance of NIAID publicly scolding a company seeking approval. Doesn't happen.