Replies to post #823175 on NorthWest Biotherapeutics Inc (NWBO)

[sage007]

GZ is not looped into the back and forth with MHRA. And even if he is, it not been public info, his hands are tied. He can’t be specific about anything. He is responsive though. Both he and Dave Innes have answered my calls. Even Les use to. I’ve even asked them if an RS can be done (though it hurts us retail investors) to uplist. They’ve always maintained, they don’t know and it’s not up to them. I don’t think anything can really be done strategically by the management till approval. Uplisting now would tie their hands in terms of dilutions. And without diluting, keeping the lights on would be even more difficult. So we are, for a lack of a better word, trapped, till this tunnel opens up into some kind of a light, however faint. I really do dread the ensuing months without approval.

[DrHigh]

He can blame MMs all he wants but they have done nothing to increase demand and have continuously added to supply. Econ 101. They need to actively work on buying demand. What have they done to do that. And is there a reason why not. Is LP going to do some stock swaps with other Toucan owned companies? Would a depressed stock price benefit those future partners??? I don’t understand why they have made zero efforts to get buying interest in the stock. Or if they have they suck at it

[Investor082]

It’s clear that it will be a conditional approval. No NICE evidence submission, almost 6 years post data lock proves that. They know it too!

Expect more sell off based on this update tomorrow, LOL! ;)

[SinfullyKorean]

Thank you for sharing these emails, but like GZ has stated, there is nothing that they can do besides wait in terms of approval AND SP. I am expecting to hear approval by end of May based on estimates done by Chigary and Baxer, which seems in line with what GZ is hinting but it seems he is not clear of timeline as well by saying it by weeks/months. 1 MIL+ LONG - also, he seems pretty certain about approval and I am as well. How long is anybody's guess but the outcome seems certain based on all the signs.

[jesster64]

"WE’RE SETTING UP THE LEUKOPHERESIS UNIT IN LONDON in preparation of MHRA approval, whenever that happens."
I thought they set it up to help with compassionate care cases.

"To try and do anything is a waste of valuable time that we are using instead to advance the company’s objectives."

so they can do something but chose not to?

[Zardiw]

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Z

[flipper44]

“NO. The licensing of the leukopheresis unit is NOT part of the review process.

However, it’s likely that the MHRA reviewers have learned about it since it was disclosed in a PR.“

That second paragraph is hard to decode.

I mean maybe someone at MHRA groaned they’ll be tying up all the Leuk clinics, and so NWBO got on it.

Or,

It’s a cue to NWBO that they really are anticipating a rapid ramp.

Or,

???

[antihama]

Thanks for sharing. I’m a little taken back GZ stating

"Whether it’s a full or conditional approval remains to be determined, but either way it will enable us to launch DCVax-L in the U.K."

I didn’t think conditional approval would be in the cards for GBM/rGBM but would be in the cards for a grade 3 or less glioma. The way he said it puts conditional approval on the table for GBM/rGBM. As he said either way DCVax-L would be a marketed drug but w conditional approval there would be more rigorous annual renewals to ensure compliance. And w either full or conditional approval, they would no doubt be running additional trials to support/expand initial approval. Still GZs statement is a little bit of an eye opener.

[beartrap12]

I found this comment by GZ from the email 10Baggerz received very interesting:

Last week I was in San Diego for AACR annual meeting networking and meeting with people who will be able to collaborate with us and who are our supporters.

The way it is written (people who will be able to collaborate with us....) sounds like he's talking about "done deals"...like maybe he's putting the final touches on contracts (plural). It's a very awkward way to write something....unless you're trying to tell people something you can't tell them.

Just saying...crossing t's and dotting i's before the signatures make it final?
Right before, or at, approval??

Of course, I could be reading too much into it.

I'd love to see approval come tomorrow, but we're now in the zone where the new MHRA regs are live, so there's no concern that our trial jumped the gun (even though we believe that date was the beginning of April).

As for full approval vs. conditional approval, we really need full approval on GBM, otherwise the shorts have ammunition to disparage buyers and generally confuse investors. I suggest that GZ's comment on this issue may have something to do with giving conditional approvals to other possibilities such as DCVax-L plus poly ICLC, or Grade 3 GBM, or DCVax-L WITHOUT SOC radiation and chemo. I think they have so much evidence that DCVax-L works without Chemo/rad that they may need to approve it conditionally if they want DCVax-L/polyICLC to be the new standard of care. The UK is all about saving money on drugs that don't work, and may even be harmful, I can see this happening.

P.S: Thanks to another poster who offered the idea of these conditional approvals on this board a few days/weeks ago.