Ann: Manufacturing update and clarification of Abcam engagement, page-6

I agree. The manufacturer in Australia may well not be approved to manufacture for the US market - not because they aren’t up to standard, but perhaps that’s just not where their business lies. Seeking FDA approval if they don’t already have it would likely require a pre-approval inspection (whether on-site or remote) and there could be months in between initiation and execution of the audit. The FDA inspectors generally have a significant queue of work. All of that is also assuming that the Australian manufacturer has the capacity for the volumes that PIQ expect they will need. A US-based manufacturer already approved for the manufacture of other similar types of test kits would likely not need a pre-approval inspection and will also be able to supply the N hemisphere more quickly due to reduced transit times. If I was running PIQ I wouldn’t want all my manufacturing eggs in one basket in any case.