MSB (ASX) Ann: Appendix 3G and Appendix 3H

Originally posted by JB1975: ↑

I....like many others no doubt......after reading these transcripts are still trying to rationalise why the FDA made the ridiculous decision to ignore the overwhelming recommendation of their own 'hand picked' ODAC committee voting (9-1) in favour of approving Ryoncil......and provide a proven & viable successful therapy in the ABSENCE of any other VIABLE alternative !!!! ?????

I vaguely remember learning about rationalisation in high school as part of critical thinking in English class and rationalising wasn't the same as reasoning. Rationalising was more like believing in that rationalising involved selectively reading and attending to that which accords with what one hopes or wishes or believes to be true.

The world can be a complicated place. So we tell ourselves stories and construct narratives that we think/hope/believe capture the essence of the complexity - but almost inevitably because we are biased we end up constructing our narratives from biased data.

If one really wants to know why the FDA reached a conclusion that is the opposite to what one wanted them to reach then there is still a lot of material available in the public domain. There is the FDA briefing material that went out prior to the ODAC meeting and there are the two transcripts for the AM and PM sessions and the slide presentations from almost all of the speakers - I believe Artur Caplan's may be missing.

IF one wants to differentiate between what is true and what one merely wishes were true, the short narrative that one keeps telling oneself or that gets passed around amongst those who believe the same thing, then one can make lists from the information in the public domain.

Simply go through the material (there is quite a lot - its not like reading a post on hotcopper one has to make a commitment - but its not beyond the capacity of people that can post to hotcopper to read a few hundred pages of transcript and a few hundred pages of briefing material.

An exercise that I have not seen done, and I think could be done usefully, is the construction of all the objections no matter how apparently ridiculous or unclear made by anyone associated with the FDA in the public domain materials. Then go through and see if there are counter arguments or facts offered in reply to those objections or problems raised. This is much harder work that posting something that is likely to get ticks of sympathy about how outraged or unfair something seems. But at the end of the exercise you have a comprehensive list of what the FDA has objected too specifically and what has been said in reply and you can then see what has not been addressed.

If there is a science or legal or statistical argument you don't understand then note the argument and be honest that you don't understand and then you can probably find someone that can walk your through it.

Rationalisation - fitting fragments we find pleasing into conclusions we want to be true is easy but it isn't likely to give us a proper picture of what is true - nor is it likely to cause us to collect arguments and facts together that can persuade someone on the other side (the FDA is law bound and science bound ultimately a corrupt person or persons can be exposed if all their arguments are shown to be incorrect in front of others that have an interest in what is true ) - we tend to demonise those on the other side when we do that - whereas taking their objections as objections one at a time gives us a list that if answered should persuade them or those that were persuaded by them.

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"I believe Artur Caplan's may be missing"

It's Arnold and from memory it was mainly self promotion and self congratulations. It was forgettable, I remember that!

Here's one quote from Arnold that I remember "this is a watershed moment".

Arnold and Artur speak fluent arse.

I reckon the acceptance speech from Arnold and SI etc. were written over a decade ago. Therein lies the problem.

Posters here refuse to admit that management screwed up the trial and/or negotiations with the FDA. They can not see it no matter what. Even though they have witnessed Fred Grossman's execution and the fall out of Novartis, yet zero blow back to the FDA.

Love is blind.

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Ann: Appendix 3G and Appendix 3H, page-32

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Ann: Appendix 3G and Appendix 3H, page-32

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