The FDA doesn't release these kinds of pre approval communications with companies. In fact they didn't release the CRL. It was reported by MSB because it was market sensitive news. FDA releases information in preparation for public meetings like ODAC and will provide backgroud post-approval. But pre approval everything is commercially confidential and it is up to companies to keep the market informed.
Ann: S&P DJI Announces March 2022 Quarterly Rebalance, page-66
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