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nidan7500

01/06/24 10:47 AM

#446436 RE: bas2020 #446432

bas2020

Not a waste of time if the FDA is impressed by the complete package of trial data, OLE and RWE evidence. Agree... AD is priority #1, but that doesn't mean drop Rett.

...agree.

As an old lab rat I have observed WW where results can(and often are) more easily and enthusiastically supported when they confirm the biased thinking of the people performing the study. So, RWD and RWE ... like videos of a young girl using stairs after treatment or preforming other daily routines present solid-directly measurable-verifiable evidence of of efficacy. When incomplete or uncertain causal solutions are being evaluated (like XXXX vs AD) then stats become proof-evidence, particularly when the true cause(s) have not been V&V 'd . People get paid a lot of $$$$$ to perform such work, while others stand back roll the dice and play the STATS game about results.

Having assessed and verified (or not) what people/institutions (WW) will do or say to get $$$/results (WW) I can/do form my own opinions on methods while working to be open minded about (+/-) results. Believe it or not, some WW cultures are more trustworthy than others. Not every country (read culture) has evolved the same value set and in fact there are many places where (IMO) only some (+/-) of what you see/are told is in fact the truth. There are several WW cultures which I have learned (the hard way as a conformance/compliance auditor) where very bright people cannot be believed , AT ALL.

Strongly advise people here to use the ignore function or exercise passive ignore often. There are some (posters) who present as credible but whose history clearly show bias. If you have not personally experienced what I am describing then , think about it before you act on it. Not all WW cultures value the truth , some may even be laughing the dumb (XXXXs) culture .