Oct. 14 at 1:04 PM
$DNLI Some added color on the delay.
https://www.fiercebiotech.com/biotech/denalis-hunter-syndrome-drug-latest-be-hit-fda-decision-delay
"In separate notes Monday evening, analysts with William Blair and Evercore ISI wrote that the delay came after Denali flagged an incorrect molecular weight for the drug shown on a public source. Because the FDA often uses such sources to inform its pharmacokinetic analyses, Denali "proactively" flagged the discrepancy, according to Evercore ISI's note, and the FDA responded by asking for "updated molecular weight info directly" from the biotech.
“Management believes that, due to the nature that the discrepancy was identified late in the review cycle, procedurally it made sense for the agency to issue a major amendment, extending the PDUFA by three months,” the William Blair analysts wrote."
