MSB Trading - Aug 2020 on, page-623

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lukewarmtin

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11/08/20

10:05

Post #: 46444726
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Originally posted by kervio: ↑

Hi everyone, I've pulled out the important part of the FDA document for reading:

"As stated above, FDA’s position is that the analytical methods used for product characterization
of remestemcel-L do not have a demonstrated relationship with clinical outcomes. We ask the
committee to consider the product attributes identified by the Applicant as CQAs and discuss
whether they are adequate to ensure that the manufacturing process will produce lots of
consistent quality. Additionally, given the limitations of the current CQAs, and the state of
knowledge in the field of MSC, we ask that the committee discuss other product characteristics
not previously identified as CQAs for remestemcel-L that might provide more meaningful
measures of product quality and potency."

To break this down, the committee is looking for a way to ensure that the manufactured cells are going to be as effective as the cells that were proven clinically effective in the study. Their point of view is that because this area of medicine is so new, there are not widely agreed standards by which to test the quality of the cells, they see some issues with the standards being proposed and therefore they don't want people getting ineffective cells and dying because they were taking something that doesn't work. Their recommendations are that they improve both the quality measures and testing of the product and discuss some standards for identifying quality cells. This is undeniably a hurdle, but depending on the outcome of the discussion between MSB and FDA it could be a small hurdle or a big one. My personal level of concern is about 4 out of 10... I expect a retrace though today as people take profits and overreact to this news, but DYOR.

Expand

Thanks Kervio. A good analysis and summary.

Efficacy is not an issue.

The FDA wants to put in place 'standards' that allow replication in the manufacturing process.

Having worked in the area of 'standards' in a previous (telco) life, I'm not worried at all.

To me, setting 'standards' in a completely new field of medicine is the FDA doing their job. The are pressure-testing the 'nuts and bolts' of the manufacturing process.

And I for one assume SI and LONZA are all over this.

Worry factor: "Next!"

All IMHO.

MSB Price at posting: $4.87 Sentiment: Buy Disclosure: Held
19 Upvote

0 Great analysis

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MSB Trading - Aug 2020 on, page-623

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