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01/19/25 2:51 PM

#480997 RE: Investor2014 #480995

There is a huge difference between skepticism and negative spinning:

Skepticism and negativity are related but distinct concepts. Here's a breakdown of their key differences:  

Skepticism:

Focus: Questioning claims and seeking evidence.  
Motivation: To understand the truth and avoid being misled.
Approach:
Involves critical thinking, examining evidence, and considering alternative explanations.  
Open to changing beliefs based on new evidence.  
Outcome: Can lead to a deeper understanding, more informed decisions, and a more accurate worldview.  

Negativity:

Focus: Finding flaws, emphasizing the negative aspects of situations.  
Motivation: Often driven by pessimism, cynicism, or a desire to criticize.
Approach:
Tends to focus on the downsides, ignore positive aspects, and dismiss evidence that contradicts their viewpoint.  
Resistant to changing beliefs, even when presented with contrary evidence.
Outcome: Can lead to a pessimistic outlook, missed opportunities, and strained relationships.
Here's an analogy:

Skepticism is like a detective: Carefully investigating a crime scene, examining evidence, and considering all possible suspects to find the truth.
Negativity is like a cynic: Assuming the worst of everyone involved, focusing on the flaws, and dismissing any evidence that contradicts their initial suspicion.
In essence:


Skepticism is a healthy approach to critical thinking that helps us evaluate information and make informed decisions.

 
Negativity, on the other hand, can be a barrier to growth and understanding.
It's important to cultivate a healthy dose of skepticism while avoiding falling into negativity.  

The problem many here see with the naysayers is that they fall into the negativity category, not the skeptical.
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Steady_T

01/19/25 3:34 PM

#481002 RE: Investor2014 #480995

Since you requested a rebuttal to you paper comments....


Quality of the Paper: Peer review is more than an initial quality check. It is a validation by people experienced in the field who examine the paper, it analysis, and its conclusions. The ultimate arbiter of the "claim's universal validity" is an almost meaningless phrase, but let's assume that it has some meaning. The "ultimate arbiter" will be time and the overall the continued advancements of the field.

Role of the 58 Authors: Of course all 58 authors did not contribute equally to the paper. That intuitively obvious. Each author contributed his or hers area of expertise. What is important is that the 58 people put their signature and reputation on that paper. That means they agree with the paper and its conclusions. The is a lot of expertise in different areas agreeing with the paper.

Regulatory Approval:No one suggested that the EMA and FDA base their decisions solely on the authorship or reputation of those listed. You are creating a straw man argument. The RA do consider peer reviewed papers in their regulatory decisions as one of the many factors that they consider. The FDA has said that it likes to see peer reviewed papers on a drug that is applying for approval.

Limitations of the Paper: Of course the paper acknowledges the "key" limitations. That is a standard part of a scientific paper. Every paper has limitations. Journal papers are necessarily limited in size and can not go into the depth that NDA or EMA filing would. Again that is an obvious statement. That is why the Journal paper 12 pages and EMA and NDA filings are in the many tens of thousands of pages.


On Constructive Discussion: Your final line gets it right. "In summary, the presence of expert authors on a paper enhances its credibility but does not make it immune to scrutiny. Engaging with the reasoning behind skepticism instead of dismissing it outright helps cultivate a more informed and respectful discussion."

The problem is there has been not nearly as much skeptical reasoning as there has been cynical negativity.
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Guzzi62

01/19/25 8:35 PM

#481028 RE: Investor2014 #480995

No, I am aware that the peer review don't give automatically approval, but for me, it's the DD it provides. I believe in the journal, but not so much self-proclaimed experts posting on a message board.

Role of the 58 authors: I heard that the first name on the list is the main author and the last name on the list is the 2nd most important person writing the journal, but I haven't got that 100% confirmed!

So in our case, the main persons are, if above is true:

Stephen Macfarlane
The Dementia Centre, HammondCare, Melbourne, Victoria, Australia

Marwan N Sabbagh
Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, Arizona, USA
Corresponding author at: Barrow Neurological Institute, St. Joseph's Hospital and Medical Center 240 W. Thomas Rd.; Phoenix, AZ 85013, USA.

My layman conclusion is that we will get approval with EMA because there isn't anything they want (EMA) out there and Leqembi is only for a very small group not likely getting brain bleed.
"Docs" conclusion at 4% likelihood is just plain space cadet IMO.
Phase 4? Yes, likely, but that's fine, isn't it?