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viagra didn't save anyone's life except of course yours, ex
ps
Now I get it why you are being such a d..k against NWBO. 😉
I take Powers seriously when she said that the Health Economic Model did not happen as of the last ASM.
What has not happened either is:
- No BLA
- no EMA MAA
- no other medical cancer trials
- no staff hired responsible for the commercialization of DCVAXL
- no joint trials
Its completely unclear what the heck NWBO staff will be doing after UK approval
Hopefully, they will wake up from their extended holiday and be kind enough to enlighten us on the game plan is, after UK approval. Better yet hopefully they will be bought for $11 billion and be done with it.
ooh my bad but its still accurate lol
Powers did mention there have been talks with different large pharmaceuticals for joint trials but she walked away because of the bad terms they offered. Large pharmaceuticals therefore are aware of NWBO's presence. Also, each big pharma has a research department for what is going on in the field of cancer drug development so they could not have missed the JAMA article.
No I think no large pharma dares to partner with NWBO until an RA of repute has regulated DCVAXL, something btw that has become more of a trend with medication in the developing stage.
From Chat GTP
******************
In the UK, biotech and pharmaceutical companies often begin Health Economic Model (HEM) assessments for NICE (National Institute for Health and Care Excellence) during the later stages of clinical development, typically after phase III trials are nearing completion or have provided enough data on the clinical efficacy and safety of a new therapy.
Here’s a typical timeline for when a company would start this process:
1. Phase III Trials:
By the end of phase III, companies usually have robust clinical data showing the effectiveness and safety of the treatment. These data are essential for developing the HEM because they provide the core inputs for estimating health outcomes, such as quality-adjusted life years (QALYs).
Companies may initiate internal discussions around the HEM during this time to support decision-making and pricing strategies.
2. Pre-Submission to NICE (before Market Authorization):
Prior to submitting a dossier to NICE, companies usually have a draft of the HEM ready. This model assesses cost-effectiveness, long-term health outcomes, and the broader impact of the therapy on healthcare resources.
The company may begin engaging with NICE through its Scientific Advice Program to get early feedback on the economic model, clinical data, and the design of the submission package.
3. NICE Technology Appraisal (TAs):
The formal health economic model, often in the form of a cost-utility analysis, is a key part of the NICE submission for Technology Appraisal (TA). The company will provide a detailed dossier, including the HEM, once the product has received (or is close to receiving) marketing authorization from the MHRA (Medicines and Healthcare products Regulatory Agency) or the European Medicines Agency (EMA).
The timing aligns with the expected approval date so that the company can receive NICE guidance at or soon after launch.
4. Post-Launch Modifications:
After submission, NICE may request revisions or further analysis based on additional real-world data or longer-term efficacy data.
Key Factors Influencing Timing:
Clinical Data Availability: Companies need robust data from clinical trials to populate the health economic model.
Regulatory Milestones: NICE submissions are often tied to the expected timing of regulatory approval.
Stakeholder Engagement: Companies may engage with NICE early on for advice on model development, especially if the therapy addresses an unmet need or has a novel mechanism of action.
In summary, health economic model assessments for NICE usually begin as companies gather sufficient phase III clinical data and prepare for regulatory submission, often starting before the product has marketing authorization but well after early clinical trials.
**************************
So as of last ASM NWBO is, as always late and negligent
I assume this has already been posted here
well
After UK approval I think we will hit $1.5. $1.5 because it corresponds with the previous ATH market cap. After that
- if there is no other news that will assure investors that the relentless dilution has stopped I think we will fall back to 90-80 cents and in the weeks after that perhaps even lower
- If with news that NWBO has received a large sum of money as an upfront payment for a licensing deal and or to conduct joint medical trials (as they promised on different occasions) then I see the SP soar +$3
well as it now seems we will be at around 32 cents when UK approval is announced. Disappointing as always
Ooh just buzz off. If you can only trust someone if everything that he or she has said would always come to pass and was always the truth and nothing but the truth then you can only trust your labrador.
thank you senti
I didnt look out for reteweets
I have been going all over his Tweets from the last 2 months, nothing about the human MIA being granted
Do you have a direct link to this tweet
79 is the new euhm 75 ;) lol
I really hope for a BO or a merger, considering NWBO's age
Sentiment Thank you for your elaborate view of the FDA's guidance on the use of external controls for clinical trials with individual patient-level data/ ECA's. Can you then please comment on why the American Brain Tumor Association seems to be more concerned about the FDA's proposal to require the inclusion of patient-level data in marketing applications than you are?
Thank you for replying
03 May 2023
the problem is Citadel will never want to admit they are spoofing and or have manipulated so for LP its a choice to take a deal of perhaps $ 150/ 200 million Citadel buying of discovery, or keep this lawsuit going on forever with a highly uncertain result. With the limited resources NWBO has and Cohen's working commission-based, that choice should not be very difficult.
I dont think LP is inept (Les is) I think they are semi-grifting shareholders with Advent (and before that Cognate), putting their self-interest before shareholders
no they will not be rejected for MHRA approval stop that nonsense.
No biotech can slow-walk an RA decision.
as pointed out many times before production capacity is NOT a condition to file/to be accepted as a valid BLA. Quality of the production is.
no its the you dont want to hear reality alert
agreed
as discussed before the knowledge and ability to follow simple logic is astoundingly primitive for most poster zealots here.
We can only hope that management has arranged a serious financial deal with a large pharma company on condition of UK approval, most probably settling the SP above $2.
I predict that you will sling more BS on this board
I predict that you will post more gibberish and kindergarten logic
Yes my prediction of an SP x5 tot x7 SP from where we are now after UK approval is a short prediction that is based on manipulation, sure sure
someone burst your toddler fantasy and the only thing you can come up is that poster must be a short blabla simpleton
Double your medication
in the US we do not have summer vacations. Thats an European thing
I couldn't agree with you more.
The uneducated uninformed nonsense that circles around here about NWBO and knowledge of nonrevenue biotech in the development stage is staggering low and very worrisome. The problem is that many NWBO longs invest based on the echo nonsense chamber that this IHub platform has become.
This board is nothing else than an echo chamber for cult members and a nonsense pusher for short bashers. The reasonable voices such as yours mine and Femike's are seldom and we are attacked by both the zealots and by the bears.
I have been on the Anavex board for a while and the level of education and knowledge of posters on that board is of much higher quality than this board.
within the EU it never was permitted to short-sell an OTC stock, so there never were short OTC positions in the first place