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$1.61 mesoblast limited

Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-304

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whytee

17,199 Posts.

2428

09/08/24

00:54

Post #: 75133881
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Originally posted by Bazsa ↑

Replying to Reg
https://hotcopper.com.au/posts/75086866/single

"
3. Clear failure to include evidence of effectiveness compatible with statute and regulations, for example:

a) Lack of any adequate and well-controlled clinical trials, including use of obviously inappropriate or clinically irrelevant study
"

What is the chances that the FDA has opened the door to a BLA for the third time and have again overlooked the above grounds for refusing to accept the BLA ? CRL 2 was all about this.
The FDA have accepted the BLA.
Would this mean that the reason given in CRL 2 , failure to include evidence of effectiveness compatible with statute and regulations, would have been checked and checked again and again. Pre BLA meeting , general check of BLA and then again to see if we have adressed the CRL 2 issues.

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I guess you will find out in 6 months time?

MSB Price at posting: 92.5¢ Sentiment: Sell Disclosure: Not Held
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