[refurb]

You can educate yourself on the FDA process, including public access to all the FDA documentation, including meeting minutes and sponsorship slides. It’s all there on fda.gov

But instead of doing that you’ve decided to just write this comment instead and post something that looks quite silly for those that have taken the first approach.

[pharrington]

When you navigate to the Clinical Trials section[1], the "View Clinical Trials Guidance Document" link[2] currently stalls, and then gives a 403 error page that says "Page Not Found". All of the information is not there on fda.gov, and whoever's in charge is doing a very sloppy job.

[1]https://www.fda.gov/science-research/science-and-research-sp...

[2]https://www.fda.gov/node/358362

[dmos62]

Do you have any insights?

[refurb]

The claim that “the industry has decided how they want things to work” is laughable.

The numerous “not approved” decisions makes that plainly obvious. Not to mention all the times FDA has said “you have to do X to get approved” and the company happily complies despite it delaying sales by several quarters.

To the question at hand “why do publications come after FDA approval”, the FDA has access to all the data (actually more) before publication, so the publication is irrelevant to approval.

[hvb2]

> Not to mention all the times FDA has said “you have to do X to get approved” and the company happily complies despite it delaying sales by several quarters.

The company happily complies?

Or just does it begrudgingly because not doing it delays sales a few more quarters if not indefinitely?

I'm not sure where you're getting the idea from that a company would happily do anything additional. It's a cost of doing business. Let's not pretend they're angels, they're in it for the money not the greater good.

And if that last statement needs a rationale, tell me who is doing the work to find the next antibiotic or any other non chronic disease medication

[rendall]

Do you feel that the happiness of the company is salient to GP's arguments? That is, by refuting that part, do you refute the entire?

[hvb2]

I took issue with the happy part because it's a regulator not a customer kindly asking for a change.

Even if the cost of the change are very high, getting it approved is probably worthwhile. To say that they would do so happily implies that there's a motive beyond getting approval.

Based on these comments, maybe my interpretation was just off

[laughing_man]

I'm pretty sure any certain path to approval makes the company happy. Ecstatic, even. They get to move the drug from the liabilities to the asset column of their ledger.