Inspections are over with, based on the grammar used in the 10K management analysis.
10K said: The Company continued working with teams of specialized consultants on the MAA process, including onsite inspections in the U.K. and U.S., and ongoing production of documents and information before, during and after the inspections.
AI says:
Yes, based on the wording "continued working" and the context of the provided text, the activities described are in the past, specifically referring to actions that have already taken place and are now completed.
"continued working": This phrase suggests that the company's work with consultants and the MAA process was ongoing in the past, but it's not stated as something happening currently. "including onsite inspections in the U.K. and U.S.": This implies that the inspections have already happened, as they are being described as part of the past process. "ongoing production of documents and information before, during and after the inspections": This indicates that the document production was a process that happened both before, during, and after the inspections, placing the actions in the past.
The very next sentence in the 10K says:
The Company is actively engaged in the ongoing process, and the Company has decided not to attend ASCO this year in order to stay focused on interactions with the MHRA and efforts to move forward as quickly as possible.
ME: There's nothing here that tells us what the "ongoing process" is. Could be they're discussing manufacturing timing for artisan vs. automation with MHRA, or how to cover all patients in the U.K. (Note that management is working deals with outside clinics for various needs...clean rooms, leukapherous units). This is not easy, pulling off not only a first-of-its-kind personal vaccine, but also a first-of-its-kind manufacturing plant making one-of--a-kind vaccines! There's lots of moving parts to get straight, not to mention quality control.
the Company plans to announce the results when the MHRA review and decision-making is finished
I found this to be an odd way to to tell us when we could expect to get the results. Why not just say, "We'll announce the results when we get them"? To me, it sounds like management is telling us specifically that they're waiting on the MHRA to "review and decide"....not to inspect.... not to gathering documents and information.
I know someone brought up the past tense use in this MAA section yesterday but I didn't have a chance to look at it carefully. Now that I've had a chance, I don't think anything written in this portion indicates we're in a certain 70-day portion of the application or that we're in for any kind of required long delay. Instead, I think we're in the "decision happens when MHRA decides it happens" portion of the application. This is just my opinion of how to read this section...based on grammar and word usage! FWIW
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