I'm happy that the FDA has gone that way of allowing adults to be the advanced troops that's not my point the point is the unpredictability because the FDA is STILL developing their policy, and that's an iterative process where SI and team go to them and advance their reasoning. It begs the question why they haven't gone the direction of AA in the first place. Just make the pathway clear. They ignored the advice of their expert team, but the reasons why are unclear too if they could have done AA and taken the advice of the expert team and then made it subject to post approval reporting.
You read stuff into my posts (like I'm unhappy that this is proceeding? well not happy with the delays but it's you who's been making the noise mate, and being damaging in where you imagine fault lies: with SI only? come on! All I ask for is fairness. Hold the FDA to account, not just haul SI over the chat room coals!
You haven't done your homework or you'd have read the Endpoints article and seen the reason why it underscores my approach on not vilifying SI and maybe conceded that the FDA is still developing its policy. It's a work in progress. Delays are ensuing still.
Even though the topic of the thread remains, it appears you aren't quite as red hot angry with SI anymore and might even be:
facing the abject reality that you don't have the numbers to roll him and never did and never will,
You were just venting, nothing more nothing less.
That's the reason despite the thread topic you have actually stopped repeatedly calling for SI to be removed, or showing believable reasons why he should be.
Calling me out for supposedly not doing my homework is funny in this context.
You can repeatedly claim superiority with your data analysis and it doesn't change the iterative situation with the FDA who are still developing the policy which of course includes data requirements, but it also includes unmet needs, and mortality baselines which make double minded clinical trials just a bit redundant, and you can see where they're appearing to give ground and where they have been somewhat pointlessly inconsistent or bloodyminded depending.
Or maybe you're so blinded by a love with data that you fail to see what's driving this.
I will spell it out for you again then:
The FDA has been confused. It's slowly appearing to reach an approach years after the fact, that it could have reached with the abject decision to require more data but not giving an AA in the first place with the requirement of post approval reporting.
And the assays and manufacturing requirements were developed out of curiosity Because with other approvals the FDA waves them through EVEN THOUGH they don't even understand why it works. Because pharmaceutical drugs they're used to that!
But with the mesemthymal therapies it's SAFE. The FDA know that. It's another absolute. Like the 70-80% mortality rate with aGVHD is an absolute.
So in this context they decide it's good enough to not understand why pharmaceutic drug therapy which is so often UNSAFE, works just so long as that doesn't cause have a lot of deaths, and it takes colossal studies and massive costs to do that...and they get enough data with those massive trials to show it KIND OF works in enough patients so that's enough...this is the kind of inconsistency I'm talking about. You're not talking apples with apples. It's a very mixed bag with the FDA but you think shouting clinical trials so many times it changes this absurdity? NO it does not.
Now in the article they're saying they sincerely hope to not have situations like that happen again of ignoring recommendations of its own expert committees. Because implicitly, when that happens it's a stuff up.
It's going to be an interesting meeting that within 45 day one, for everyone's career, not just SI's.
You can directly or implicitly demand that anybody who isn't a data expert like your good self cannot have a valid opinion and you'd be wrong.
Because policy underpins FDA requirements and it drives those requirements - or should do - and that involves a well-informed balancing act.
So it's policy first then the law. That's how it's meant to go at least in the regulatory world that's how it is. But you imagine I with a regulatory background have nothing of value to contribute.
You're a specialist and you can make mistakes on context and judgement.
You can have as many followers as you manage, it doesn't make your stance or theirs on this any more correct.
I'm impervious to followers and TUs and interested in the dialectic, that out of a discussion the truth will emerge.
The truth exists regardless it's a matter of whether you can let yourself pivot or not to a different mindset.
The developer of lateral thinking Edward de Bono said we in the western world need a new word, where we suspend critical thinking and petty point scoring long enough to fully absorb the points being made into a cohesive whole.
He called it "po". Then to re-engage in discussion it's about being fair-minded.
You have been remarkably lacking in fair-mindedness and civility towards SI, and attacked him instead of checking your own assumptions.
Best read the Endpoints article then? I look forward to your commentary on that elsewhere. Happy reading!
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