Ann: Submits New Information to FDA IND File for SR-aGVHD, page-123

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03/10/22

21:58

Post #: 64007034
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Originally posted by JB1975: ↑

I'd agree with your 14 days - IF MSB/Silviu had said they'd completed the BLA resubmission.

But if its not a complete resubmission that's occurred (ie if MSB still has other material it needs to submit to satisfy the CRL matters) I'm not sure the 14 days applies yet.

To me this reads like MSB has gone back to submissions in installments (like they did previously with the first BLA submssion) rather than that they've made a single complete resubmission that addresses all matters in the CRL.

I read this announcement as being ambiguous - even deliberately and enigmatically so - so as to say something to meet an expectation that something would be said by quarter end, but also not to say very much.

Perhaps MSB is hoping that the FDA will look at the data that has been given them in this announcement and provide feedback on it in the true spirit of a rolling submission - which I get the impression the FDA may not always live up to - in that the FDA may not provide feedback on each installment in a rolling submission.

What is definately still necessary for the FDA to do to grant a BLA is for there to have been a site inspection. Passing such a site inspection at Singapore would be such a important thing I suspect that MSB would announce it (especially if the result is positive) - but perhaps until that has occurred MSB is trying to understand the FDA work processes and work within those to keep its options as open as possible.

"Mesoblast has maintained an active dialog with the FDA since receiving the CRL, and the substantialnew information submitted to the Investigational New Drug (IND) file for remestemcel-L in the treatmentof children with SR-aGVHD, as guided by FDA, represents a major milestone in the Company’s completeresponse to the FDA."Stockrock you've shown an interest in understanding the FDA work process previously as has LearningEachDay.

I still find that phrasing "maintained an active dialog" quite ambiguous because I don't believe the FDA can be communicating particularly often or informally but a dialog can still be active in certain contexts even if there isn't a lot of it in terms of quantities of discussion or frequency. Perhaps a couple of meeting since ODAC could be considered "maintained an active dialog", by FDA standards.

I find this announcement interesting, but I don't feel much wiser about where MSB is at. I do think that MSB is giving the FDA a chance to object if the FDA wants to to some data they've generated on potency assays and such, so they've given the FDA a chance to not surprise and disappoint with bad new.

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Whether it’s technically a “resubmission” or not is a distraction. What’s important is that it’s progress!

MSB Price at posting: 84.0¢ Sentiment: Buy Disclosure: Held
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Ann: Submits New Information to FDA IND File for SR-aGVHD, page-123

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Ann: Submits New Information to FDA IND File for SR-aGVHD, page-123

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