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"Protocol 275 is not an adequate and well-controlled trial and...

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Bazsa

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28/09/22

12:10

Post #: 63918965
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Originally posted by JB1975: ↑

You wrote : the additional data from the 241 patients treated with Remestemcel-L through the FDA approved EAP will dramatically improve the BLA resubmission's chances

Bullet point 2 (in a list of "key points emphasized by the FDA") on page 10 of the FDA Briefing Document for the PM sessions, August 13, 2020, says -

"Protocol 275 is not an adequate and well-controlled trial and does not provide confirmatory evidence of efficacy to support a license application."

That document is on the ODAC website in the event materials (still I presume) as I'm quoting from a hardcopy.

I see your blue bolded excerpt from MSB's announcement stating -

"Mesoblast has now generated data from the expanded access program (EAP 275) of 241 children which confirm the ability of the in-vitro potency assay to measure product activity relevant to survival outcomes".

Why do you think "the additional data from the 241 patients treated with Remestemcel-L through the FDA approved EAP will dramatically improve the BLA resubmission's chances"?

Can you talk through a chain of reasoning for that?

Do those words of the FDA's not sound like they might be coming from a sort of governing US Code or a regulatory requirement to you? They certainly do to me.

I read both those statements as being made in an historical context. Protocol 275 cannot be rerun. So it seems unlikely to me that the FDA will change their mind that it was not an adequate and well-controlled trial.

Could they change their mind about it. Going from "does not provide confirmatory evidence of efficacy to support a license application" in light of new data? To instead being - okay it wasn't an adequate and well controlled trial in itself, but nonetheless, in light of the new data you've shown us, we do agree that it does now provide some confirmatory evidence of efficacy to support a license application".

Expand

"Protocol 275 is not an adequate and well-controlled trial and does not provide confirmatory evidence of efficacy to support a license application."

This is from a briefing document for ODAC. Even if the statement is still valid it doesn't mention that biomarker data is not valid.

MSB Price at posting: 82.0¢ Sentiment: Buy Disclosure: Held
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