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96.0¢ mesoblast limited

Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-296

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ddwn

12,456 Posts.

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09/03/23

10:19

Post #: 66671964
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Originally posted by JB1975: ↑

So - they don't need another trial, period. It's a factual certainty.

No it is not.

The FDA needs to have at least one adequate and well controlled trial to approve a BLA.
They may not approve without at least one. But they hold within themselves the authority to determine what is an adequate and well controlled trial. And they are not borg they are a collection of individuals - they will disagree internally and amongst themselves from time to time as will the officers and agents of any largish organisation.

MSB needs (unless they do another one) Study001 to be that trial.

It cannot be that trial if MSB cannot link outcomes with product given to a satisfactory level of scientific and statistical certainty.

That certainty doesn't have to involve a randomised controlled trial - it usually does - but it doesn't have to.

But it does have to be there.

And it is not yet a fact that MSB doesn't need another trial.

It is likely, in my opinion, they will. But it is possible they won't. But in no way is it a fact. And it won't be a fact until the FDA says it is a fact. Not me, not you, not MSB. The FDA has the authority.

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If push come to shove on this, then IMO the AA will likely be the best outcome for all concerned

MSB Price at posting: $1.05 Sentiment: Buy Disclosure: Held
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