Replies to post #536140 on NorthWest Biotherapeutics Inc (NWBO)

[Reefrad]

You tell us

;)

[Turner5]

Nasdaq , partnership, uk manufacturing approvals , uk approval, rest of RA applications , combo results, this year. Buyout next year

[flipper44]

Commercial manufacturing license for Sawston facility.
Confirmation of MAA/submission.
MA with temporary reimbursement stopgap.
News of BLA app.
Etc.

[exwannabe]

For reasonably likely milstones:

. Advent gets their license to commercially manufacture approved biologics.
. ASM vote on either R/S or raising the AS limit to ~2.5B.

For possible milestone:

. Advent completes more work on SOW 6 (not the entire SOW).
. The ex-Flaskworks team completes another milestone towards getting the device approved to make an ATL-DC for clinical trial or Specials use.

[VikingInvest]

Personally, I think that they are well into the application for approval process, so don't expect any news in this regard in the near future (2-4 weeks).

I think that the next milestone will more than likely be the MIA for Sawston. It could literally come any day.

I would love for us to get some results released from the combo trial, as I know some who have been expecting this for some time. I think they had to wait for the JA to get published before they wanted to talk about the combo trial, as it gives them a solid idea of the future of approval for Mucidencel, which is important as it is the central drug for the combo trial.

I doubt it will happen, but an uplisting overnight (either with or without an R/S, depending on SP) would be nice. Regardless of what Ex says, I have been told by attorneys who specialize in listings that this is absolutely possible.

Further down the line, I expect we will get some MAA and BLA news, as I expect we are well into these processes.

Also, we could see additional journal articles with a more in depth discussion of the stats.

Other than that, I do not think that NWBO will be bought out for some time and I think that management need to let this permeate for a little while before putting ink on any JV or partnership. As the news spread and the SP hopefully moves up on this, they would likely be in a much stronger position later this year or earlier next year.

JMHO

[carp77]

Seriously the man with tens of millions of shares why don’t you tell us what you think will happen PLEASE…

[j e d]

Could you please share your thoughts on the matter?

[W_W]

1. MIA for Sawston 2. Combo patent

[CrashOverride]

I expect a lawsuit announced anytime. That's the only explanation for the silence of Adam Feuerstein.

I think we will have MHRA approval this year.

[OncoJock]

GOOD QUESTION

1. Company press release announcing MHRA has granted approval/certification for commercial manufacturing operations at plant in Sawston before end of this year
2. Company press release announcing MHRA has accepted its application for marketing authorization for DCVax-L, 1Q 2023
3. Announcement (from company, MHRA, or both) that marketing authorization has been granted and some indication whether DCVax-L will be added to standard formulary and reimbursed for patients of the NHS in the UK, also with dosage and pricing information, 2 or 3 Q 2023
4. Company press release announcing that commercial sales have begun, with some indication of initial sales volume, order volume, order backlog, or all three, 3 or 4 Q 2023

5. Total blue sky/wild card/hopeful contingency for which I have no evidence at all and I have no idea when it could happen (but ATLinsider has been talking about this possibility for months if not years and it makes total sense given recent public statements by Richard Pazdur MD about Project Orbis):
FDA announcement of simultaneous approval of DCVax-L in recurrent GBM across at least 2 jurisdictions (USA and UK) and perhaps 3,4, or 5 (European Union, Canada, Japan) etc.

[sentiment_stocks]

Adding to some of the other’s possible upcoming events (not necessarily milestones), I suspect that some sort of contract with Charles River Lab in the next several months may be in the offing. Of course, I could be wrong on that but I think it’s reasonable to suggest.

Lawsuit (fingers crossed) to stop the monkey business.

Any moment, proxy… will there be anything interesting to vote on, or same ol’, same ol’?

And as others have suggested, submission of the completed MHRA application.

[pgsd]

In a 2019 presentation (slides below), Dr Bosch listed a number of specific new trials said at the time to "start in the coming months" I expect to get news on some of these in the near future:-

"The first 2 of these new trials are anticipated to start in the
coming months"

DCVax-Direct - New Trials
Ø Brain metastases of lung- and breast cancers
Ø Pediatric diffuse intrinsic pontine glioma (DIPG) and supratentorial high
grade glioma (SHGG)

Novel clinical trial designs using DCVax-Direct will be explored
in severe unmet medical needs

https://nwbio.com/wp-content/uploads/ASCO-2019-Presentation-FINAL.pdf









https://nwbio.com/wp-content/uploads/ASCO-2019-Presentation-FINAL.pdf

[Know-Fear]

Short week with the holiday domestically not conducive to major announcements. But this holiday week is especially conducive to stories like the JAMA article and Liau’s presentation to gain traction in the media. So, if there are any major announcements this week it’s likely to come from across the pond with manufacturing the most likely followed by MHRA submission.