And in case any newcomers think I'm just some downramper trying to ruin the fun, this is from MSBs official announcement. Nothing I've said is incorrect.
Huge difference between what was formally requested by the FDA, and what was submitted. Think the FDA will be impressed their recommendation wasn't followed?
When they ask, and they absolutely will ask, why MSB didn't do an RCT, especially in adults, where ethical issues are fewer.... what will MSB say?
The evidence requested and the evidence provided is wildly different.
Maybe it'll get through. But Si is rolling some seriously risky dice with all of your money. Why not just do what they wanted?
Ask these questions. It's your money.
And in case any newcomers think I'm just some downramper...
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