FDA ODAC Meeting Material discussion analysis, page-61

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11/08/20

20:07

Post #: 46465073
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Originally posted by JB1975: ↑

"Overall, I'm quite satisfied with MSB's responses addressing FDA's concerns."

With respect I think you are reading the timeline backwards. What you are referring to as FDA concerns are arising after not before reading MSB's briefing material in my opinion.

For example consider the statement from the 10 page FDA Briefing Document on page 4 -

"The Applicant has defined critical quality attributes (CQAs) for remestemcel-L that are proposed to be related to the potency and activity of the product (see Section 5.1 Critical Quality Attributes in the Applicant's briefing document)."

The FDA could not make those sort of references if they hadn't already read Mesoblast briefing document (or at least a draft of it that was pretty close to complete).

The way you have structured you post suggests to me that you believe Mesoblast has already responded to the FDA concerns in their briefing - it seems to me you have the order the wrong way around. To me it seems like the FDA have responded to the briefing with concerns and questions and those now need Mesoblast and/or the advisory committee to address them.

For instance continuing on from the quote above I see this statement -
"FDA's position is that the product attributes the Applicant has identified as related to potency and activity, however, do not have a demonstrated relationship to the clinical performance of specific DP lots, and that the product's proposed immunomodulatory mechanism of action has not been demonstrated in vivo in study subjects receiving remenstemcel-L. Without a demonstrated relationship with clinical effectiveness and/or in vivo potency/activity, controlling these CQAs may not be sufficient to ensure the manufacturing process consistently produces remenstemcel-L lots of acceptable quality".

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I wasn't sure of that on first reading, so thanks for pointing that out.

I'm not sure flipping the order, i.e. FDA saying, "We've read your briefing, now explain it further and answer these questions" changes much in terms of Mesoblast's approach to the meeting. If anything, they've got about 2 days to gather more evidence and answer with confidence!

MSB Price at posting: $3.36 Sentiment: Buy Disclosure: Held
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