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Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-203

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Zenox

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08/03/23

16:23

Post #: 66662779
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Originally posted by dachopper: ↑

You're simply wrong zenox.

Lets travel back in time, and have a look what the actual press release stated, rather than twisting and implying the facts:

It was a sunny morning on the 2nd of October 2020, depending on where you lived. The birds were tweeting, the share price was hovering around the $5 AUD ( 500% higher than today ) when the trading halt followed by BLA update occurred.

https://hotcopper.com.au/threads/ann-update-on-bla-for-graft-versus-host-disease.5662970/

Please read the entire sentence from the press release, I have Bolded the points you are ignoring.

The FDA recommended that Mesoblast conduct at least one additional randomized, controlled study in adults and/or children to provide further evidence of the effectiveness of remestemcel-L for SR-aGVHD.

We now have 1 year, 2 year, 3 year and 4 year survival data that the first BLA did not include. ( New evidence of effectiveness )
We now have survival outcomes proven to be greater against other trial control arms, and matched control arms that were in the same hospital, at the same time, and propensity matched with our trial ( New evidence of effectiveness )
We now have a new release assay specification, which has been post hoc confirmed within the trial, and within other studies that the efficacy has increased verses the phase 2 / phase 3 release specification used ( New evidence of efficacy )

Now..... the recommendation was to provide further evidence of efficacy...... Not for the sake of conducting another trial.

It was only a recommendation

Mesoblast have provided further evidence of efficacy.
That 4 years survival data , combined with the new release spec shows the best efficacy they will have ever seen for any product for SRGvHD from what I have researched.

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

They need further evidence of efficacy, not another trial.

Expand

So the FDA mentioning an RCT is irrelevant then?

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Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-203

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Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-203

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