northmark1
Oct 30, 3:58 PM
$RFL Immanent Failure? Money and Hope are running out. This Could be the End folks. This was a big week for RFL. On October 28, Cyclo Therapeutics submitted a New Drug Application to the FDA for remibetadex to treat Niemann-Pick Disease Type C. The catch is that the trial did not meet its primary endpoint in the overall population, though a prespecified subgroup on background therapy showed significant benefit. The NDA requests a pediatric priority review voucher. Full-year results were also released: the net loss narrowed to
$29.6M from
$30.5M. Two things to keep an eye on: cash fell to
$22.1M from
$52.8M a year earlier, and management reports substantial doubt about continuing as a going concern. The next catalyst is whether the FDA accepts the application for filing.
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