Replies to post #627773 on NorthWest Biotherapeutics Inc (NWBO)

[attilathehunt]

"The MHRA will also implement a timeline for completion of an application review within a maximum 30 days in general, with a maximum 10 calendar days for a decision to be granted once the regulator has received any final information.

Submission by 9/25....Approval by 11/10....Veteran/s Day!!

[maverick_1]

Not forgetting what ENSUED below & from WHOM in what turned out to be their OWN CONTENTIOUS MIS READINGS & ILL LOGICAL befuddlements that underscores still unaddressed MYOPIA seen in this waste land since 2014!

Time sequenced progression & rampant obstinacy of MADDENING CROWD:

NON STOP CIRCUS:

maverick_1
Re: maverick_1 post# 626461
Wednesday, August 30, 2023 2:18:36 AM
Post# of 627783
Newfound Expeditiousness in UK MHRA’s in Approvals, transparency ETC

LIKELY WHY IT IS NO COINCIDENCE NWBO Communique SAME DAY!

As iwasadiver (Greg Zivic) I don’t believe it was just a coincidence!

StonkMaster
08/30/23 4:44 AM
#626482 RE: maverick_1 #626470
WRT the 30 day timeline, is it referring to application review for acceptance or approval?

Sorry for the stupid question.

maverick_1
08/30/23 8:29 AM
Post #626500 on NorthWest Biotherapeutics Inc (NWBO)
BTW contained & BOLDED in post re Newfound Acceleration @MHRA:

The MHRA plans to shorten the timeline for the completion of an application review to a maximum of 30 days, and a maximum of 10 calendar days to make a final decision upon receipt of further information.

[Not Semantics

Social Media DESTROYING Society WW!

LIVES don't matter to FUDSTERS just $

DIFFERENT STROKES for DIFFERENT FOLKS

Astavakra
Re: maverick_1 post# 626500
Wednesday, August 30, 2023 8:37:47 AM
Post# of 627794
It would be great if this applies to us, but, when read in the original context you posted, it specifically refers to Clinical Trial Registration. It does not mention MAA.
Bullish
BULLISH

hoffmann6383 08/30/23 8:51 AM
#626513 RE: StonkMaster #626482
referring to clinical trial registrations imo, not the same thing
Bullish
BULLISISH

maverick_1
08/30/23 9:15 AM
#626524 RE: Astavakra #626502
Asta why no one else make that assertion???

Your revealing hip shot OVERSIGHT

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172717232
Bullish
BULLISH

Astavakra
08/30/23 9:19 AM
#626526 RE: maverick_1 #626524
[See hoffman post 626513
referring to clinical trial registrations imo,not the same thing

Then re-readthe MHRA announcement

bas2020
08/30/23 9:25 AM
#626533 RE: Astavakra #626502
Agreed... Otherwise, NWBO would've requested the new 30-day review, in its PR, rather than 150.

Astavkra
08/30/23 9:30 AM
Post #626542 on NorthWest Biotherapeutics Inc (NWBO)
I'm long 13+ years and as eager as anyone for success.Sometimes in their eagerness, people see what they hope to see when they read something like the new MHRA guidance on clinical trials. I get that. But these types of misreads, as they are repeated, quickly become gospel. I suggest people go to the source and read and decide for themselves what is being said.That's they only reason I decided to comment on Mav's post

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maverick_1
08/30/23 9:40 AM
Post #626553 on NorthWest Biotherapeutics Inc (NWBO)
Why not make it simple:
MHRA in that PR should have been clearer:
why they, not me, include the MAA clause
AND state
Only for NEW Trials

OR better yet:

Not Applicable to Pre Existing Marketing Approval Application

My MISREAD? on Bureaucratic legalese & protocols

Astavakra
08/30/23 9:50 AM
#626562 RE: maverick_1 #626553
They have no reason to. The MHRA statement is 100% clear. I can't help more than that, so I'll leave it at that.

dstock07734
08/30/23 9:59 AM
#626571 RE: maverick_1 #626553
It is still exciting news.
The UK special program can be a very successful model using RWE for approval. Hopefully, in the next stage, there will be no traditional type of clinical trials. [color=red]]Just using RWE is good enough for approval[/color].

pgsd
08/30/23 10:00 AM
#626572 RE: maverick_1 #626553
I cannot see how anybody can look at the quote below and then state this is just about guidance relating to the clinical trials aspect. The text is pretty clear

A series of new measures will be introduced by the Medicines and Healthcare products Regulatory Agency (MHRA) with support from partners to make it faster and easier to gain approvalAND to run clinical trials in the UK

https://www.gov.uk/government/news/mhra-to-streamline-clinical-trial-approvals-in-biggest-overhaul-of-trial-regulation-in-20-years
Bullish
BULLISH

Then re-readthe MHRA announcement

georgebailey
08/30/23 10:26 AM
#626592 RE: Astavakra #626542
Asta I agree with your interpretation MHRA is about streamlining clinical trials.
We already have evidence the app can be approved in 30 days after accepted.
However, this acceleration agenda will come in very handy as nwbo pursues everything accept GBM.

maverick_1
08/30/23 10:27 AM
Post #626594 on NorthWest Biotherapeutics Inc (NWBO)
Thank you Peter
AND that's from one who BOTH truly plies into UK HC developments and is domiciled there.

[color=red]]So even a PM exchange in last few minutes with Hoffman understands my viewpoint and agrees.[/color]
AND I have never been dogmatic or argumentative.

Apologies to all

The ABOVE RAMFIES yet AGAIN the ABSENTIA in LOGIC &

Let alone COMPREHENSION of not only those above applicable posters

BUT that since 2015 NOTHING much here has changed despite having

a SWAT TEAM previously identified

AND since 2015 NWBO has been a MIRACLE.

GHASTLY, & BEYOND PATHETIC is an UNDERSTATEMENT

SO Piss poor MENTAL INEPTITUDE PERIOD is why this board & most posters are not worth paying attention on this

BIG Press Release re REVAMPING 20 Yrs how UK MHRA NEW Regulations.

Instead scientific one’s even a lawyer’s dealing with[color=red]]DETAILS (PICAYUNE) took center stage[/color]

vs The BIG PICTURE

Truly PATHETIC! , MUCH WORSE for sidelined lurkers & populace who are new & in
PENNY STOCK land ETC

AND NO Retractions, let alone apologies RAMIFIES this board & posters POPULARITY EGOCENTRIC orientation PERSISTS!

Can’t wait for BIG Players with their own TSUNAMI to MUZZLE the UNENDING NONSENSE

BRAVO for Peter Davis that has a LT history on this AND BEFORE NWBO generated his 1st Retirement FUND from Neil Woodford PRE 2012 when Woodford was at INVESCO!

Peter has admitted in 2019 his view of Woodford FUNDS BIGGEST UK financial DEBACLE.
Woodford FUNDS went from $19 BLN & ShUTDOWN at $3 BLN IN 5 yrs in World’s Biggest Bull Run .

No one except moi saw it BEFORE it IMPLODED ( Sold ALL at peaks >$10 while others here Bought & 2-3 yrs later began accumulating back beginning at 50 cts.

INSTEAD ALL here was RATIONALIZING INCORRECTLY that Woodford with $195 mln invested into NWBO with a $6.85 avg per shr cost would average down his cost basis. That was center stage from 2015 thru 2019! 10,000 + posts DOCUMENTED of NEOPHYTES , coverups you name it!

The damage to 292,000 other UK ‘ers on Top of THE FAILURES of 2017 BREXIT ETC are inherent in current UK Financial Budgetary CRISIS!

99+ % have been OVERWHELMED in this EPIC thinking investing is easy AND may belatedly begin to recognize their OWN SELF INFLICTIONS which there is no humility.

DIFFERENT STROKES for DIFFERENT FOLKS

[maverick_1]

EPITAPH

With the amply displayed & documented……

UNPREPARED, IMPERMEABLY RIGID minds(??)
demonstrably UNADAPTABLE & INSOLENT mindsets since 2014
In traversing the expansively diverse but narrow STEEP Winding
TREACHEROUS TERRAIN in this unsuitable investment.

Too many Big EGO Cooks(???) not heeding early posted advice of DEEP PROFESSIONAL EXPERIENCES has been the result…….

Flogging, castigating, and even denigrating management never gets results.
Only mounting a difficult proxy contest may!
(I did it on the 1st try! Documented.) while others
pontificated & failed at prelims of organizational level.
That was the 3rd member of that TRIO.

No matter how much Pissing in the wind on every key encounter since 2014
NOBODY was equipped nor Experienced:
INFLATED EGOS of NEOPHYTES prevailed!
UNABLE to read or handle the handwriting on the wall

Since 2014 OVERWHELMING daily sweet NOTHINGS
(commiseration is NOT resolving)
due to the roundtriping $3 to $12 …CRATERED to FIFTEEN CENTS!

Huge LOSSES (both realized & UN realized)
CEO Linda F Powers had GINORMOUS LT Losses
OFFSET by HUGE gains selling Cognate to CRL
Nobody knew or posted till mine reveals the
EMPTY Due Diligence on ALL CRITICALS!!!
Highly unlikely for others to duplicate what LP DID

Clearly MASSIVE financial & personal dislocations
exacerbated by OTHER biotech CRATERS in their “portfolio”

AND detected LATE…real time MOLES 4 CHAOS

100% TRANSPARENCY for DARK Forces

Plus BIG EXASPERATED BRAIN DRAIN

HIDDEN(??) CARNAGE & DEVASTATION

The world is rife with PARASITES & PIRANHAS seen here
& identified early, Bully Pulpit Pied Piper NEOPHYTES went OVERBOARD

Herding FLOCKS off Yosemite FALLS

EASY Reading even of devious Personalities.

They will undoubtedly take credit for it’s rise from the DEAD.

FACTS vs SPIN

DiFFERENT STROKES for DIFFERENT FOLKS

[StonkMaster]

I hate that I keep asking this, but can someone point out where in this document it says they plan on speeding up application timelines for Marketing Authorizations?

We've established the 30/10 days are for clinical trials, not marketing authorizations, right??

I'd love to be wrong.