Made me laugh.
The FDA game is mostly won by big Pharma. SI has been banging on with the donkey/carrot/stick story for decades. He made the decision to proceed with all trials coupled with 100% of the risk in the USA (either that or the continuous Big Pharma deal discussions were all BS).
We are now here with our own genitals in our hands blaming the FDA. We went to war with water pistols that SI told us were nuclear.
Reread the articles pre and post ODAC if you can find them (and the ODAC minutes itself). Fred Grossman was making noises that they were ‘short’ but positive and after ODAC and SI lost his mind and blamed the FDA, Fred wanted to launch into another P3. He knew. And one assumes he knew the next P3 was the answer.
Fast forward to now, and it feels to me that Fred was probably right.
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