Replies to post #587958 on NorthWest Biotherapeutics Inc (NWBO)

[Survivor2012]

Right on the "money" thermo! NWBO has delivered on every single milestone. When DI was hired, I spoke to him for 45 minutes -- we discissed the SAP. The rest as they say is soon to be history making/paradigm shifting!! In fact, the only "borderline" bad news I can remember in my past 10 years of investing in NWBO was "the halt" -- not!! Woot, woot!!

[dennisdave]

so the turning point will be MHRA approval. From what I gather from your post is that you think they will submit for approval with the FDA AFTER they have received approval in the UK. That's what Powers meant when she said strategic submitting the requests for approval.

Anyway thanks

[StonkMaster]

Thanks Thermo

[StonkMaster]

I'm starting to get the feeling that approval of the MAA in the UK is important.

[fluteman]

Thermo, thanks.
Too much noise, indeed.

[thermo]

According to the MHRA guidance², the MHRA offers a 150-day assessment timeline for all high-quality marketing authorisation applications (MAAs), aiming at accelerating the availability of medicines for patients in the UK. Under this process, the MHRA will evaluate the application for a UK, Great Britain (England, Wales and Scotland) or Northern Ireland marketing authorisation and reach its opinion on approvability within 150 days of submission of a valid application². However, this timeline may vary depending on the type and quality of the application, and whether any additional information or clarification is requested by the MHRA during the assessment².

Alternatively, applicants can use the rolling review route, where they can submit modules of the eCTD dossier incrementally for pre-assessment by the MHRA rather than as part of a consolidated full dossier submission³. The rolling review is intended to streamline the development of novel medicines by offering periodic enhanced regulatory interaction and advice to reduce the risk of failure at the final phase³. The final phase of the rolling review should be completed within 100 days in two stages as 60 + 40 days with an intervening clock off period¹³. However, this timeline may also vary depending on the quality and completeness of the submitted modules and data³.

Source: Conversation with Bing, 4/22/2023
(1) 150-day assessment for national applications for medicines. https://www.gov.uk/guidance/guidance-on-150-day-assessment-for-national-applications-for-medicines.
(2) Marketing Authorisation Application submission dates for 150-days .... https://www.gov.uk/guidance/marketing-authorisation-application-submission-dates-for-150-days-national-and-european-commission-decision-reliance-procedures.
(3) Rolling review for marketing authorisation applications - GOV.UK. https://www.gov.uk/guidance/rolling-review-for-marketing-authorisation-applications.
(4) Rolling reviews: a useful tool to speed up the regulatory review process. https://www.vennlifesciences.com/wp-content/uploads/2021/04/Speder-Bruno-Rolling-Reviews-Feature-May-2021.pdf.

[hoffmann6383]

Thanks for the post thermo.

With a potential May or June submission (red in image) do you see approvals happening in August or September (blue in image)? Right column being submission deadline and left column being CHM meeting date.

https://www.gov.uk/guidance/marketing-authorisation-application-submission-dates-for-150-days-national-and-european-commission-decision-reliance-procedures

[Doc logic]

thermo,

“...and, upon UK approval, Fuerstein will Tweet...?”- thermo-

Maybe something like “I hope they have grapefruit juice as good as this in jail”.

Best wishes.

[Rh2022]

Thanks, Thermo.

What’s the other 10% you’re referring?

[timung]

Nwbo, yes AF will tweet..."90% of risk and 90% of reward" ?

[jfr1611]

“Company value will discount all the above and more.”

Agree once they get UK approval, the stock will closed a huge valuation gap and will probably discount the rest of the world (row).
However, when you’re saying “…and more”, are you making reference to a possible short squeeze that will inflate the stock price above “realistic value”?

Thanks Thermo

[hope4patients]

Thermo,
Any thoughts regarding valuation 2-4 months post UK approval for L in newly diagnosed and recurrent GBM?

[iclight]

Over a billions shares is the result of this “access to sufficient capital”. If any institutional investor agreed that financing would’ve happened already. Instead it’s “hope for some BS spoofing settlement”

[martyDg]

NWBO will delivered, the question will we get a good share price boost? Unless we get out of this pos OTC sp will remain less than a $ and every pump is temporary and very disappointing. What’s the next pump MAA approval everyone will go back to bashing as the sp goes back to descending behavior.