Saturday, February 24, 2024

But that's actually number one that the FDA, and every other regulator, has to approve is the manufacturing package.  It's called chemistry manufacturing control.  First, that has to be done.  After that, you can talk about safety and efficacy.  Because if you can't manufacture what you're saying your manufacturing, who cares about safety and efficacy?  We don't know what we're testing.  Yet all the big scientists all the big doctors all they talk about all day is safety and efficacy but nobody looks at the manufacturing.

Not just that you can make what you said you would make but that you can make it consistently when you go and swallow a Panadol what you call over there Tylenol you expect that pen at all to be the same product you swallowed the last time you're not expecting variability of that Panadol or else you wouldn't take it.  You're expecting a drug manufacturer to make the same product the same tablet, right?

Same vial same everything in my newt precise quantities in billions of doses so it needs to be extremely precise extremely consistent well characterized I was giving people the analogy and imagine if you go to the bar and get a beer and then next week you go to the same Pub and it's a thousand percent different beer either you know twice the alcohol or no alcohol or some other compound and flavor.  Well you might be dead of alcohol poisoning or maybe it was just water.

Yeah so it wouldn't be right so manufacturing is the big deal so you could see in that document that the EMA regulators

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