Hopefully DECN'S kit won't fall victim to the FDA
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Posted On: 04/12/2020 11:51:46 AM
Re: mrmaskedman #9735
Hopefully DECN'S kit won't fall victim to the FDA bias and preselection.
We will know before this coming week is over. My personal belief is that the antibody methods came to the attention of someone in at least an upper-middle position at the FDA that is saying "over my dead body."
Reminds me of a meeting I had with the FDA in 2011 where we were having trouble getting clearance from FDA staff, so we asked for and were granted a face to face meeting. 35 FDA staff showed up, just a room full of people. And the manager of these people made a comment that I remember to this day because it was the most naive and dumbest comment I had ever heard. And when this FDAer said it 35 other heads nodded yes. It was stupid, biased, and retaliatory -- and dead ass wrong. But it held up clearance until this lady went on maternity leave. FDA is its own religion.
We will know before this coming week is over. My personal belief is that the antibody methods came to the attention of someone in at least an upper-middle position at the FDA that is saying "over my dead body."
Reminds me of a meeting I had with the FDA in 2011 where we were having trouble getting clearance from FDA staff, so we asked for and were granted a face to face meeting. 35 FDA staff showed up, just a room full of people. And the manager of these people made a comment that I remember to this day because it was the most naive and dumbest comment I had ever heard. And when this FDAer said it 35 other heads nodded yes. It was stupid, biased, and retaliatory -- and dead ass wrong. But it held up clearance until this lady went on maternity leave. FDA is its own religion.
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