Replies to post #690535 on NorthWest Biotherapeutics Inc (NWBO)

[Dan88]

My reading of the Q regarding this question is that certainly the company has been preparing us for a bit longer for approval, because usually if there are no inceptions, there will be no approval.

Nonetheless, the biggest part of any such inspection(s) is to inspect the readiness of the underlining manufacturing process which has already passed although at the time the MIA was issued the MAA had not been submitted yet. But essentially they are the same. I don't think is necessary to inspect it again/

So if other inspections are still required, they would be minor in comparison with manufacturing inspection part.

Then, there are two scenarios:

A. If MHRA deems those minor inspections are unnecessary or if it has already inspected before during compassion use approval process, etc., then the approval may come any day in the near future; and

B. If MHRA's inspections occur shortly after 10Q, ie today, then it won't unreasonable to expect the approval may occur before ASM by the end of June.

[dstock07734]

meirluc,

I assume they use the same manufacturing facility to deliver the vaccines for over one thousand patients in compassionate use program. I don't see the necessity of additional MHRA inspections. But I suspect I could certainly be wrong.

[ccie1024]

I read same.

I also read their “validation” language as to the effect of we discovered inexplicable delays only from working with NICE but from that have as of March 7 confirmed MHRA have commenced phase I. The delay was not caused by error on our part.

Perhaps nefarious forces across the pond have been underestimated.

[kabunushi]

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'.

[Arby2000]

Isn't the 10Q written to reflect events and status as of March 30th, 2024? If so, inspections could have taken place since then to maintain the 150-day timeline for May 19th or soon after that.

[hankmanhub]

it seems that additional MHRA inspections are still
pending and have not yet been scheduled. Also apparently
in preparation for those inspections, the company is arranging
for additional mock inspections.

Meirluc, I don't get it. Why are these inspections not included in the 150 day schedule? Or could they be in response to an RFI with a clock off period?