What would the Health Scare woos make of this, do you think?

[TZ]

I learned about something new with the FDA yesterday. Apparantly our company is moving one of their new drugs from Phase I to Phase II clinical trials but before they do that they are submitting their results and experimental design for Phase II VOLUNTARILY to the FDA for feedback and advice. From what I understand, these early submissions (designed with the newest protein/genetic products in testing in mind) can streamline the submission/review process later on, since the FDA will have had an early look at the research. The consultation involves FDA scientists and company scientists..not politicians...Anyway, I found it interesting and it seems to me like it would be an excellent way to streamline a somewhat cumbersome and expensive process.
But I thought after the seminar, what would the woos say to that? They probably think its all some sort of secret handshake lunch where bribes are swapped to rubber stamp the drugs.......:D

[cosmik debris]

1. Remember the anti-vax woos saying that Congressional Hearings

Were just as important as clinical trials? How many times have they cited the hearings as evidence that vaccinations are killing our children? Now you want to take politics out of the system???? YOU HEATHEN YOU!

[Warpy]

2. I think they'd take that as a smoking gun,

the final evidence that there is indeed collusion between Big Pill and the government.

Now that thimerosol is gone and autism is still being diagnosed, they're desperate for another cause.

[trotsky]

3. Bribes are swapped, sure, but don't forget about...

the divvying up of the babies they will kill with that new drug.

[dropkickpa]

4. I can only imagine what they'd say

The process makes a lot of good sense to me. The investigatiors can get an idea of what they need to do to get approval, can get guidance, and speed up what is usually a lengthy process of back and forth question/answers and revisions.

**I do something similar with my PI's, I'll have them submit a copy of their proposed protocol and go over it with them pointing out things they are missing, procedures they need to add, point out areas likely to draw questions from reviewers, etc and it really helps to streamline the approval process of everything needed is there on the first official go-around.