Grapire most feel there has been a change of requirements from the FDA over time at least once.
Right now my interpretation is that approval will be given for children under 12 ( maybe to 18 ) but some sort of conditional trial will apply to adults within the year.
SI was really pissed and definitely not collegial after the initial change from the FDA.
Some have also suggested the FDA's original advice was not properly listened, or adhered to as well, but all indications are that some 10 million plus has been spent in these areas since then to address them.
Ann: S&P DJI Announces March 2022 Quarterly Rebalance, page-60
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