The FDA is a corrupt organization., page-51

The 'we need adult data to approve kids' is the bit that stocks in my claw.

I struggle to see how this improves our understanding of paediatric treatment.

The jaded view that it's time wasting.

The positive view is that it's all good data.

What the company now need to be very explicit about with the FDA is what the circumstances are under which the trial will be deemed a success and unlock approval.

This really should be a binary outcome now.

Achieve X, you're in. If not, you're either out or need to do more.

I would hope that the success definition should be a relatively low bar given that this is salvage territory on patients who are actually expected to not make it.

I've gone through the depressed part, have started thinking a bit more positively and am now looking forward.

Pass me the Koolaid!