[icegreentea2]

But also remember the other invisible graveyard - the people who aren't dead because they received ineffective treatments.

I do agree that drug approval processes need to consider the negative cost of delay, but in this specific case, from further in the article we see:

> Moderna is currently building a dedicated facility in Massachusetts to produce the vaccine at commercial scale, which it hopes to finish sometime next year.

> "We need to make sure that we have that near completion before we could even contemplate asking for approval," Hoge said.

And the reason for this is that you typically need to submit detailed manufacturing information as part of your new drug approval process. This allows the FDA assess how likely the drug you actually sell will provide the same benefits as those in the trial, as well as make sure you don't like... dunno forget to serialize stuff and ship out contaminated product.

[JAlexoid]

The approvals themselves are much less efficient, than they aught to be.

In so many cases, the changes trigger a review of the whole process - rather than the changes.

[pas]

to be fair, mostly because biology/pharmacology/medicine is vexingly treacherous.

but! generics can get easy approval, they need to show that their active ingredient is the same molecule and it has a very similar biological uptake profile, and that's it (at least in Europe, but as far as I know it's very much copied from the US process)

so that's not that high bar. and of course "big pharma" knows damn well how to change just some little thing to have a different-but-same molecule but with a few more years of patent protection.

(and again, yes, it's not that the process is super duper trivially applicant friendly, but the costs in the system are not in the filing.

it's mostly because there's no real common infrastructure for the whole end-to-end iterative process. there's a lot of separate cottage industries for each step, all charging a fuckton of money, all providing mediocre services, mindboggingly shitty software for managing trials/data/patients, no incentive to improve, doc/xls based workflows, you can imagine how inefficient and slow - and thus extremely costly - these specialized services can be, etc.)