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Re: meirluc post# 690535

Friday, 05/10/2024 11:58:04 PM

Friday, May 10, 2024 11:58:04 PM

Post# of 693684
I share your caution that this seems to indicate that MHRA is not going to be completing their total review process within a few weeks. I would have to imagine that the referenced statement was as of release of the 10-Q or possibly a short time before the release when the Q was being written. The inspections mentioned don't sound like they are related to the manufacturing facilities but rather a kind of audit by on-site inspection of main trial sites and possibly some other site(s) chosen at random to confirm by visiting and physically inspecting e.g. that all the documents and data referenced in the application are indeed preserved at the various trial sites. I would take this to be 'your application makes various claims, let's not just take your word for it, we need to actually go onsite and see for ourselves the preserved trial info' just to be sure there is no hanky-panky about the large amount of data that is claimed in the application. In as much as I would imagine this means a limited number or maybe even just one team from the agency traveling around to look-see multiple sites. If on-site visits have not yet even been scheduled as of today, even if the RA is super well-organized it's a stretch to think they will get it done before the end of this month. If the RA is quite organized it could get done by sometime in June. If not, well NWBO is completely at their mercy wrt their getting visits scheduled, coordinating with the sites to be visited etc.

I think this is a very clear warning that things seem to be going quite well in general, but there is still this non-trivial activity that still had not yet even been scheduled. NWBO has no control over how quickly those inspections get done, other than making sure that everybody to be visited is well prepared to have the visits concluded without any issues. It does seem like this is waving a red flag saying 'folks, don't expect the approval to get done by the end of May 'cause that clearly ain't gonna happen'.
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