Replies to post #592335 on NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

Unfortunately for your speculative post, it was already approved. Obviously the FDA always reserves the right to reconsider on an application, but that appears unlikely.

[Springbok80]

Already approved by the FDA...yet again wrong and grasping at that piece of grass as one hangs from a cliff.

[RPD60]

The operative phrase is “Sponsors should finalize”

I don’t see the phrase “Sponsors MUST finalize”

[The Danish Dude]

FDA won't accept NWBO P3 trial ECA:

I'm litteraly drowning in evidence that refutes that,

Everything points to, FDA will and already have.

So let me recap, what I have already recapped around 8 times and add new and exciting info.

Let's start with Al Musella refuting NovoCure "non disclosed interest" Matt Williams



FDA have removed all obstacles with regards to the use of historical controls in the DCVax-L trial.

LINK

Regarding "The Use of External Controls in FDA Regulatory Decision Making"

45 approvals id'ed where FDA accepted ext. control data in benefit/risk assessment; doing so for many reasons incl. rare nature of the disease, ethical concerns wrt use ofplacebo or no-treatment arm, seriousness of condition, and unmet medical need

https://pubmed.ncbi.nlm.nih.gov/34014439/#:~:text=Forty%2Dfive%20approvals%20were%20identified,the%20high%20unmet%20medical%20need.

As well as 13 authors from FDA, including Pazdur, published the article "External control arms in oncology: current use and future directions" in Annals of Oncology

https://www.annalsofoncology.org/article/S0923-7534(22)00006-0/fulltext

... which is considered to be a huge positive for NWBO, as walked through here by Larry Smith-

https://smithonstocks.com/northwest-biotherapeutics-fda-statement-regarding-use-of-external-controls-in-clinical-trials-is-a-huge-positive/

Then came the FDA "Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products"

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-design-and-conduct-externally-controlled-trials-drug-and-biological-products

Which already in the introduction says:

"FDA regulations under 21 CFR 314.126 outline the characteristics of adequate and well-controlled studies, and recognize various controls, including a historical control, which FDA considers to be a subset of a broader category of potential external controls. FDA has accepted various types of external controls, when appropriate, for a specific drug development program"

And FDA even mandated the crossover as stated per Linda Liau:

"There was a crossover arm designed into the trial and that was actually mandated by the FDA..."

And Dr. Toms during this LifeSpan interview

"…don’t have an internal control because of changes that were mandated by the FDA…"

Then we have the JAMA article "Analysis of Supportive Evidence for US Food and Drug Administration Approvals of Novel Drugs in 2020" from May 2022.

Showing that:

Pivotal trials supporting oncology approvals were much more likely to use a historical control than nononcology approvals

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2792372

Thanks Hoffmann for this!



Organisations like End Brain Cancer initiative:

"These Patients are going to die quickly, therefore, it makes no sense to give them a placebo in a clinical trial instead of the treatment, especially when the external patient data already exists and can be used as the control arm w/in the clinical trial design/protocol for rare diseases."

And just to add that the MHRA is in on the bandwagon with historic controls, we can just look at the british Pathway to a Cure report announced a month ago, in which british politicians from the All-Party Parliamentary Group on Brain Tumours, SPECIFICALLY URGED MHRA to get DCVax-L to patients and get NICE to reimburse.

• Explore how the MHRA, HTA, and NICE can
cooperate better to enable new treatments to
be made available in the UK, such as immune
vaccination, and immune cell therapy which use
a patient’s own specific antigens and dendritic
cells respectively

• Where possible, external controls such as
previous trials data to replace placebos for
brain tumour patients

Let's hear a BIG WHAMMY for that!



And a big round of applause



https://www.braintumourresearch.org/docs/default-source/default-document-library/appgbt/btr_2667_appgbt-briefing_pathway_a4_36pp_2023_singles_lores.pdf?sfvrsn=27ac8501_3

THUS SPECIFICALLY talking about DCvax-L, which the APPGBT group have had hearings about. NO OTHER DENDRITIC CELLS have been discussed during the groups years of effort.

MHRA has already begun implementing initiatives to prepare for whats coming, with extra funding during the next two years, ESPECIALLY for getting cancer vaccines quicker "through the system" and last I looked, there were only one available.

2) MHRA to receive £10m from HM Treasury to fast-track patient access to cutting-edge medical products

https://www.gov.uk/government/news/mhra-to-receive-10m-from-hm-treasury-to-fast-track-patient-access-to-cutting-edge-medical-products

The funding over the next two years will support development of a thorough but shortened process to speed up the approval process for cutting-edge treatments developed in the UK with the greatest opportunity to meet the UK’s healthcare priorities, such as cancer vaccines and AI-based therapeutics for mental ill-health.

Next two years there are only ONE cancer vaccine in play in the UK.

ALL ARE IN ON NWBOS USE OF HISTORIC CONTROLS!

No matter how hard nay sayers are trying to deny the inevitable.

FeMike:
The $3M was probably from LP and she didn’t want to finalize the deal yet because the share price spiked 15% unexpectedly and she expects to get better terms once it drops back down again.

Can’t wait for the excuses after this nonsense speculation fizzles out. Just like the creation of Pref C’s guaranteed a partnership was imminent. Already earmarked for a huge purchase, they were. What am I going to be told when a partnership isn’t announced before the next Q I wonder…

Yet it seems like the NWBO stock magically attracts non invested retailers in a way like no other stocks, making an OTC stock the most debated, posted and read Ihub board of all stock boards.

I seem to remember I personally flee stocks, when there are no financial incentives for me to be invested and the outlook is bleak.

Somehow its different with NWBO, to a degree it is heatedly debated 24/7, on holidays and weekends by non invested retailers, who for years have argued NWBO is a "dead fish".

I wonder .... how bad should it be, before "one" actually does not care anymore and find other "playgrounds"?

Really, I'm keen to know, what makes a stock that exciting to discuss, that is an inch away from cremation?

[SkyLimit2022]

HyGro,

Your ideas do not align with the facts.

Your ECA comments are irrelevant because you don’t have to consider the ECA trial if you don’t want to—there are other DCVax-L trials. Furthermore, just like other efficacious drugs such as pembrolizumab, DCVax-L will continually be studied in other cancers and other drug combos/other PD1 combos even after commercialization. Keytruda was approved many years ago and has been a blockbuster, but it has continued to be studied in more clinical trials ever since.

There was only one ECA trial. That trial was clinically appropriate, adaptive, and compassionate.

Data collected from the P3 and ECA comparison only comprise a fraction of the clinical efficacy data that exist for DCVax-L today. DCVax-L (murcidencel) has been studied in three notable trials that have reached data collection points—only one of those three trials relied on an ECA, and the ECA included over a thousand well-matched contemporaneous patients.

Additionally, nGBM and rGBM especially are unmet medical needs having a clear and well-documented prognosis.

Furthermore, any and all lingering criticisms that naysayers may have will be dispelled during the confirmatory period following commercialization (this applies to all drugs). In the hands of practicing clinicians worldwide, we can learn more about this cell-based technology as a platform.

Skip to timestamp 8:01 when Dr. Liau again confirms that the crossover was mandated by the FDA.
https://edhub.ama-assn.org/jn-learning/audio-player/18738384


https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171254756

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171849931

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171883120

[dstock07734]

HyGro,

NotaCure board needs you the most at this juncture. The investors feel being betrayed by the CEO of the company who dumped 94% of his shares right after the PR. Since then, the share price dropped over 50%. See it yourself. The row marked by pink box.