I think Otherperspective had a go at this some time ago,

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nippy

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17/06/22

10:40

Post #: 62051846
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Originally posted by JB1975: ↑

I'd like to see a conversation on the law (and perhaps participate), and I think Southoz would be good, but can I please request that sources be clearly labelled and closely referenced - it makes it a lot easier to follow if a a quote is referenced quite specifically like to a particular page at least if not a line or paragraph in a particular named document.

There are differences between Australian Statutes of law and US law and there are differences between the time periods under claim between the US cases and the Australian cases. Though much will be in common.

A thing that is going to matter is who knew what and when. Timeline analysis. Whether defending MSB or establishing that they did something wrong the facts (when they, the facts, are public domain) can tell the true story potentially but a story always has a timeline.

Most of the FDA's position on things comes from their ODAC briefing disclosures and summaries and those statements of the FDA's usually do not put particular times on when the FDA said what they say they said so a bit of reverse engineering (deductive reasoning) has to be employed to work out when they could have said what they could have said.

I believe there have only been 8 meetings related to remestemcel-L between 2009 and now, with two of those meetings having occurred since the ODAC meeting of 12 August 2020 and with at least the first of those meetings having occurred with Osiris rather than Mesoblast because 2009 was too early for it to have been Mesoblast.

Page 10 and 11 of the FDA Briefing Document Oncologic Drugs Advisory Committee (ODAC) Meeting S ession on Clinical evidence (PM Session) August 13.2020 says

"Since 2009, FDA provided the Applicant with advice on the clinical development program for treatment of aGVHD in six meetings. Key points emphasized by FDA included:"

Then there are nine bullet points listed but those bullet points are not stated to be placed in any chronological order and the FDA doesn't say when the FDA emphasized those points - (making a case for or against themselves or MSB was not the FDA's purpose at the ODAC meeting).

There are the last three bullet points of the nine. (The appear on page 11)

"The null hypothesis for MSB-GVHD is not based on data from a historical control population. In the absence of data from appropriate historical controls, FDA is unable to agree that the proposed null hypothesis is acceptable".

"Given the absence of appropriate concurrent or historical controls, MSB-GVHD001 does not appear to be an adequate and well-controlled study. This, the trial as designed may not be sufficient to provide primary evidence of effectiveness to support a marketing application."

"Any claim of efficacy based on MSB-GVHD001 needs to take into account all studies of remestemcel-L for treatment of aGVHD, including the failed trials".

The FDA says therefore that it has said those things in its briefing note made public 11 August 2020 - but it doesn't say when it said them to MSB.

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I think Otherperspective had a go at this some time ago,

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I think Otherperspective had a go at this some time ago,

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