Hi senti, when the National assessment procedure for medicines was updated by the MHR in May, I did the same calculations, and came up with something similar. I would note that there is language in there that allows for extensions, so an exact end date can be flexible.
In exceptional cases, we may agree to extend the clock-stop period beyond 6 months.
In exceptional cases, we may agree to extend the clock-stop period beyond 3 months.
I remember posting a long while back discussing commercial pricing for DCVax, and I said that it wouldn’t surprise me if Northwest Bio acquired Advent and brought manufacturing in-house to keep the price as low as possible. I thought that this would only occur when they were actually ready to begin commercial manufacturing. The language in the Advent acquisition announcement said, “the transaction is expected to close as soon as certain legal conditions are fulfilled” which I thought might take a couple/few months. When I read the Advent acquisition announcement, I thought it probable that the approval decision was on the horizon.