Replies to post #607169 on NorthWest Biotherapeutics Inc (NWBO)

[CrashOverride]

That's not correct nor would application submission be material. The company would only need to tell us of negative feedback from a regulator such as requirement to run an additional Phase IV trial before approval can be given. We know that negative feedback like that won't be mandated as we already have MHRA approval of the post submission pediatric trial (PIP).

If regulators had a problem with our trial they wouldn't conduct another one post MAA submission, with same design as our adult Landmark Phase III, on children!!!

The company told us that they want to see MIA issued this year as well as the initiation of the pediatric trial. We have the MIA. We have plenty of time left for the pediatric trial to begin as well as full MHRA approval.

We are not late, stalled, off target, or any sort of manufactured narrative like delay which some want to propagate.

[Maverick0408]

As I have been saying, there will be no application submission/acceptance news in Q3. Only dangling of carrots (from supporters).

Per my earlier post, one of these excuses will be hyped up as we approach mid to late Q3 (in an attempt to build lofty expectations and attract more buying from retail).

1) The focus has shifted to FDA now? UK not number one priority anymore. So need more time to line up CRL and other million BLA pages?

2) Now applying strategically via Project Orbis. All RAs at once. Need extra months.

3) Flaskworks certification given off label demand considerations!

4) Tissue agnostic approvals.

5) No MAA acceptance PR. Need to wait until final MHRA approval (in 2024?) for the big reveal.

6) Rolling review already in the works. Approval(s) can come anytime.

Ultimately, they will PR MAA acceptance news but it won’t be in Q3. Highly unlikely in Q4 either. We could potentially be under 40 cents before that news ever comes. It will again be very disappointing for most folks in terms of the impact on SP.

The report in August will also be revealing in terms of the specials revenue and the financing (including C shares). I expect we will be under 50 cents before that August report comes out as some of the folks connected to the management sell a bit of their position to buy back at a lower price point later in the year. These guys know regulatory application submissions are still some months away!