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Thanks for your posts JB1975. Very informative. I have been...

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Harymeso

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23/05/22

15:49

Post #: 61569941
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Originally posted by JB1975: ↑

There isn't any doubt in my mind that some of the statements were very misleading indeed.

There is doubt in my mind.

I think I've read the southoz posts you've referenced. Where he talks about historical controls versus other terminology adopted at different time points. Is that the strongest example you can think of where statements were potentially misleading?

I note the Irene Kristal (the United States) case covers the period April 16, 2019 to October 1, 2020 whereas the two Australian prospective cases (William Roberts Lawyers is referenced in an MSB announcement and Phi Finney McDonald comes up in this thread) cover the same wider period of 22 February 2018 to 17 December 2020.

The laws of Australia are public domain. MSB announcements are public domain.

What is not public domain are the communications directly between the FDA and MSB and vice versa - what is public domain is only the statements placed in the public domain at meetings such as the ODAC meeting and where MSB reports what the FDA has said to it and in some cases MSBs reports are phrased in terms of "indicates" and "believes" so I think in fairness to MSB its possible that in some cases MSB may not even be certain what they have been told.

I think in part that MSB can be uncertain about what it has been told to some extent is because of the way the FDA does its business. The FDA has a number of guidances in which it specifically states something like the guideances aren't binding in law - they are intended to be guidances. I've also read that the FDA does not allow those dealing with it in meetings to record the meetings - rather that it is FDA policy that the FDAs reports of the meetings are to be the official reports.

In MSBs annual reports are statements like - simply that the FDA has agreed to a rolling submission doesn't mean that in fact that the FDA will necessarily look at each of the modules submitted separately and give feed back separately. The FDA seems to operate on something of an honors system in that they sometimes don't do what they aspire to do (meet their deadlines - do reviews of modules in rolling submissions as they come in separately) but as a powerful beaucracy they do what they can and have to prioritise their work in line with the human resources they actually have.

Things can go wrong or fall short of aspirations sometimes when there isn't really a villain on either side. I think that this is particularly the case when communications between companies like MSB and the FDA is as fragmented and lumpy as opposed to continuous as casual - I don't think MSB has done itself any favours by suggesting its in continuous and collegial communications with the FDA when on remestemcel-L over many years from 2009 to the present that just wouldn't have been how the FDA would have operated.

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Thanks for your posts JB1975. Very informative.
I have been wondering if MSB would announce when the GVHD resubmission is made and concluded that they would not in view of recent silent attitude. This thought has been confirmed in my mind by your post.
This been so, we are now awaiting an announcement by MSB regarding their attitude to the submission. Do you agree?

MSB Price at posting: 99.0¢ Sentiment: Buy Disclosure: Held
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