Friday, August 02, 2024 11:13:22 AM
KEY WORDS: INSPECTIONS ARE SCHEDULED! IT MEANS THEY WILL HAPPEN IN NEAR FUTURE.
LINDA LEAVES SCHEDULED DATE INTENTIONALLY OUT.
From Today's 8k, Item 7.01, "Meanwhile, we are continuing to focus on working with our teams of consultants on activities related to the review by the Medicines and Healthcare Products Regulatory Agency (MHRA) of our Marketing Authorization Application (MAA) in the UK, including preparations for inspections by the MHRA that are scheduled to take place in both the US and UK [left out: in the week of xxxx]."
[
Zadie420, I have reached my three post limit so I reply to your post here:
My understand is that inspections consists of site visits, manufacturing visits, etc. Inspections in US may be trial site visits, not including manufacturing. BTW, inspections, particularly manufacturing one is the last step in the proving process. Cheers]
LINDA LEAVES SCHEDULED DATE INTENTIONALLY OUT.
From Today's 8k, Item 7.01, "Meanwhile, we are continuing to focus on working with our teams of consultants on activities related to the review by the Medicines and Healthcare Products Regulatory Agency (MHRA) of our Marketing Authorization Application (MAA) in the UK, including preparations for inspections by the MHRA that are scheduled to take place in both the US and UK [left out: in the week of xxxx]."
[
Zadie420, I have reached my three post limit so I reply to your post here:
My understand is that inspections consists of site visits, manufacturing visits, etc. Inspections in US may be trial site visits, not including manufacturing. BTW, inspections, particularly manufacturing one is the last step in the proving process. Cheers]
Bullish
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