Update
$Mesoblast(MESO.US$ FDA Says Mesoblast Trial Data Sufficient to Support BLA Submission
MT Newswires· 1 min ago1min
The US Food and Drug Administration has notified Mesoblast (ASX:MSB) that available clinical data from its Phase 3 study MSB-GVHD001 appears sufficient to support the submission of the proposed Biologics License Application for the treatment of pediatric patients with steroid-refractory acute graft versus host disease, according to a Tuesday Australian bourse filing.
The Australian regenerative medicine company intends to file the resubmission during the next quarter to address all remaining product characterization issues, the filing states.
MT Newswires· 1 min ago1min
The US Food and Drug Administration has notified Mesoblast (ASX:MSB) that available clinical data from its Phase 3 study MSB-GVHD001 appears sufficient to support the submission of the proposed Biologics License Application for the treatment of pediatric patients with steroid-refractory acute graft versus host disease, according to a Tuesday Australian bourse filing.
The Australian regenerative medicine company intends to file the resubmission during the next quarter to address all remaining product characterization issues, the filing states.
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Trytosaveabit OP : The end of this PR has a bit of updated info!
sendhelp : hmm thinking to get back in, but I feel like it's gonna run without me in premarket![[undefined]](https://static.moomoo.com/nnq/emoji/static/image/default/default-black.png?imageMogr2/thumbnail/36x36 "undefined")
Trytosaveabit OP sendhelp : At this point I’m going to wait to see how it looks PM into MO! GL