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$1.13 mesoblast limited

The batch consistency issue may have been of some value if REM-L...

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16/11/20

09:47

Post #: 48895054
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Originally posted by RickyH: ↑

The problem, I think, that is argued by the FDA is, how can you ensure your product will work every time if you don't know what part of it is working?
You have a trial of aGVHD that used cells from one donor (I think this is correct), and it was successful. Past trials were not. The argument by SI was that the cells were enhanced for greater effect. But what part of the cells? How can you ensure the next batch will also be as potent if you can't tell what part of the cells caused the more powerful effect? How can you measure this? Do another trial to prove that you can replicate the results with your more powerful cells from a different donor. We (the FDA) will not give families false hope without clear evidence, irrelevant how safe this product is.

Please don't shoot me down. This is not necessarily my opinion. I am not well enough versed on this product to make such a judgement, but am heavily invested because I like the science and the potential.
But give the FDA credit. They have been presented with heaps of information and have come to this conclusion. It is not that they don't believe the cells work, they are not convinced that MSB can produce the same results batch to batch, donor to donor. Without some way of measuring the 'active ingredient' how can they be sure that the product will be as effective?

This becomes particularly important when FDA is dealing with other submissions. If they let this one through without having something to measure, how can they stop any back yard setup from claiming they're producing stem cells as well therefore should also have approval?

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The batch consistency issue may have been of some value if REM-L has not been used in Japan for about 5 years and JCR is growing the market remarkably. We’ve had an EAP for many years and according to Dr Kurzberg REM-L was highly efficacious.

FDA wants to make an example and show how severe they can get. By their standards (some learned commentators said their ignorance) applicants are guilty unless proven otherwise.

MSB Price at posting: $3.25 Sentiment: Buy Disclosure: Held
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The batch consistency issue may have been of some value if REM-L...

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The batch consistency issue may have been of some value if REM-L...

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Capital raisings wrap: Brainchip, Ovanti, Lake and VHM

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