Agree that Covid would most definitely wreaked havoc with the work schedule of the agency.
“The FDA is back on track, and the pace of approval is rapidly gaining steam. Their messaging is that they want to approve. Look at the gene therapy space by way of example.
You are not wrong to be cautious, but I expect the current FDA to surprise in how quickly they progress this.” - thanks again @kingfedex
Ann: FDA Supports Accelerated Approval Pathway for Heart Failure, page-274
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