BioCryst Pharmaceuticals,Inc. (BCRX)

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I watched yesterday’s conference this morning and they asked the same question about a possible delay. Stonehouse’s response was that it’s always a possibility, but their “confidence level is extremely high.” Among their reasons are having redundancy in domestic manufacturing. FDA isn’t “hit and miss” with traveling to manufacturing plants inside the U.S. and, if they’ve recently traveled to a facility and found no concerns they might accept a previous approval and apply it to the Orladeyo application. He didn’t say whether he had any info on whether an inspection had actually taken place, only repeated “our confidence level is very high.”

One would think the FDA would identify the anticipated delay and provide that information in advance: “hey, we still need to do a site visit and can’t get to it for a month or two.” Not sure what the typical practice is, though.

Conversation starts about 2:20.