Replies to post #1784 on Revance Therapeutics Inc (RVNC)

[DewDiligence]

Has the inspection occurred? On further reflection…

On further reflection I agree with your contention that there’s an alternative way to parse the paragraph we’ve been analyzing in yesterday’s PR. Here’s the complete paragraph (emphasis added):

On November 25, 2020, the company announced that the United States (U.S.) Food and Drug Administration (FDA) deferred a decision on the BLA for DaxibotulinumtoxinA for Injection due to the FDA’s inability to conduct an inspection of the company’s Northern California manufacturing facility as a result of COVID-19 pandemic travel restrictions. The inspection of the company’s manufacturing facility is required by the FDA as part of the BLA approval process. Though the company’s BLA is still under review, the FDA did not indicate any further outstanding review issues beyond the pending on-site inspection.

The tense switches from past to present after the first sentence, which would be an odd use of language if the second and third sentences were meant to refer to the BLA status back in November 2020 rather than the present status.

On the other hand, the entire paragraph is almost verbatim copy of what RVNC said in its 11/25/20 PR (https://investors.revance.com/news-releases/news-release-details/fda-defers-approval-daxibotulinumtoxina-injection-glabellar ), so it’s possible that RVNC simply inserted the language from the November PR without changing the tense.

Further, the following sentence from the November PR is not repeated in yesterday’s PR:

The FDA stated they are actively working to define an approach for scheduling outstanding inspections, once safe travel may resume and based on public health need and other factors.

So, it seems that the inspection could already have taken place after all.