MSB (ASX) Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA

Originally posted by JB1975: ↑

What I'm reading -

"Mesoblast... today announced that the U.S. FDA has informed the company that following additional consideration the available clinical data from its Phase 3 Study MSB-GVHD001appearssufficient to support submission of the proposed Biologics License Application (BLA) for remestemcel-L for treatment of pediatric patients with steroid-refractory acute graft-versus host disease (SR-aGVHD)."

So that is the company and presumably Silviu's (and or the other company's officers alltogether interpreting what they've received as a team under Silviu as the CEO) opinion.

So MSB reports the FDA says the FDA has additionally considered specifically available clinical data (that is not potency assay its clinical data) from its Phase 3 Study. That's data from a long time ago now. What specifically did they reconsider? And relative to the second BLA what more did they have to consider that they didn't have before? Has their been a change in the personnel at the FDA doing the considering? (It's my understanding Matthew Klinker is still in place).

I'm inclined to read this whole paragraph down to mean that MSB had proposed, yet again, to resubmit a BLA (for a third time) and that the FDA has, yet again, given some feedback (appears sufficient to support submission) - we've (the market has) been here before though - its "appears" its not a detailed look at a whole BLA.

"We thank the agency for their collaborative approach. The responses and guidance from the FDA are clear(*** we'll speaking for myself I think you and the MSB board have a bit of a history (two CRLs to two BLA's now) in reading clear patterns in previous communications but not showing those original documents - I grant not showing is not unusual most companies don't disclose communications from the FDA - and then acting, and then not getting the results that you thought were clearly to be expected)and provide us with a high level of confidence to refile our BLA for remestemcel-L in children with SR-aGVHD"

"Mesoblast intends to file the resubmission during the next quarter, seeking to address all remaining product characterization issues".

So this announcement treats "product characterization issues (remaining ones) as quite separate matters to "clinical data from its Phase 3 Study..."

I see that as the potency assay stuff (product chacterization issues) still hasn't been endorsed.

Overall this announcement does seem to signal that the company thinks now, rightly or wrongly, that the FDA has given it a path to go forward with a BLA submission without a further trial with adults if the company wants to have another go.

The FDA would not state that the clinical data was sufficient if more was needed - in my opinion, but in my opinion MSB could misunderstand what the FDA has said to them - indeed they seem to have a history of doing exactly that.

All the above, just my opinion, will watch for subsequent announcements. I still don't think MSB has sufficient data to be granted a BLA without a further trail.

Expand

well i think your interpretation is wrong. and sounding either desperate or jealous that our therapy is way ahead of the company that you hold.

1. assays are clinical data.

2. a second assay that was in place during the trial is the additional data that has been considered.

3. there is no separate matter, the assay addresses the characterisation issue.

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Last updated 10.13am 07/05/2024 ?

well i think your interpretation is wrong. and sounding either...

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well i think your interpretation is wrong. and sounding either...

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