Biotech Values

[p3analyze]

"I find it notable that the industry pros on this board do not buy this anti-FDA propaganda. And these pros were, almost without exception, highly skeptical of DNDN’s BLA. "

I am willing to bet that if the mechanism of action were clear, many of the PROS would overlook the type I error bullshit, as would FDA. But this also means that setting aside issue of MOA, most of these PROS could care less about type I error. Yet the main criticism was the statistical technicality when FDA has approved numerous applications with worse violations.

US FDA probably is as good an institution as a bureaucracy can be. It protects the welfare of American consumer and patients with due dilligence. There is no doubt about it. But what yous said sounded almost like the following:

When German Nazi first invaded, in many European countries, upper echelons almost without exception were highly skepitcal of resistence put up by underground guerilla. Their pessimism were well justified, but that does not make Nazi right, does it?