God forbid FDA drug approvals require a rigorous scientific review.
Where have you been since 2020? The FDA did not conduct scientific review (that is, completed clinical trials) on any of the early Covid vaccines that killed and/or maimed hundreds of thousands of innocent victims. I made it a point to read all the Covid vaccine clinical trial results and all were prematurely cancelled once the disastrous results started to surface. That "safe and effective" ship sailed years ago.
You are going to regret your position when the scientific barriers are down, political influence will wash unimpeded over the decision making process,.
I knew you would take it to the extreme and in doing so you are 100% correct as we saw with the Covid vaccine! It was “sitting on a shelf” all ready to go after a lab leaked an experimental virus…….financially supported by our gov.
Try to be a little more in the middle next time by agreeing on something like….uhhm, I dont know maybe an Fda brand new “out of the box thinking” open label, adaptive ph 2a design that looks at safety while simeoultaneously looking at efficacy while accelerating the whole process….! WAIT, we did that and it still took 10 plus years. Yah yah yah, no NDA blah blah blah.
The whole problem was that we came into the political head winds of the “liquid draino” drugs coming to market with no signs of efficacy. Some say something is better than nothing but not when it kills people and governments waste valuable time evaluating the marginal at best results and decline coverage because of this, and rightly so.
This is why Dr. Missling did not file an NDA. He went and presented the same evidence in the EU and they welcomed him with open arms. Are their Dr’s/regulators smarter than ours…..? Did they see more data than the FDA….? The answer to both is no! In fact Dr. Missling checked with the FDA at EVERY interval in the AD trial design tweeking it to satisfy and meet their requirements.
Im sorry but common sense is sometimes not even able to be bought in the greedy, intellectual, politically motivated silos that immerse our gov officials, at whatever level you say, top, botyom or everything inbetween.