Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-358

Really talk about a rhetorical trick…..he is saying they are lying by hoping they have enough data
They have enough or they do not have enough …….If they don’t have enough and they have announced several times they have enough it is lying especially at this level

I am the he you are talking about there - you referred to another comment I posted and it comes up as you reply (actually the system reports it as you 'quoting') me.

But I am NOT saying MSB are lying by hoping. Hoping isn't lying. We'll at least that isn't lying as I would use the word.

I'm not comfortable with you characterising (I think mischaracterising) me as saying MSB is lying not only because that would be leading me to have to potentially defend against a charge but also because it isn't actually what I meant.

Some of the what is happening is that people are putting their reading of other peoples words into their own understanding - but sometimes those things don't actually line up.

In this forum over and over the suggestion is made that experts like the companies experts can't possibly be wrong - but they can be sometimes and on some details. There are errors in the ODAC submissions and in announcements and a bunch of other places that can be seen as evidence of small errors even to casual observers - that doesn't mean bigger errors have been made necessarily but nor does it mean they have not. What it does mean, I argue, is that shareholders and potential shareholders can and should be critical. Neither putting MSB or its officers up on pedestals and certainly not slandering them.

But the slander move (hey that guys is slandering my favorite much loved company rep - when usually they aren't) is also pulled on HotCopper to try to shut up criticism by other posters.

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MSB can be stating they have a validated potency assay - in their announcements - and believe it to be true (so not be lying) and it can still not be true that they have a validated potency assay.

It comes down to how a potency assay is validated (somewhat) and who does the validating for the decision as to whether it is or not is done. The pretty much final call on whether the potency assay is validated (in the absence of evidence allowing observers to do it for themselves - and perhaps in their presence as well) is going to be the FDAs.

But scientifical laws and logic trump even governments. Its theoretically possible to have institutions and the law validate something legally (for a time) and for the validation to be bogus.

For a while Thalidomide (might be spelling that wrong) was available in Australia.