Key upcoming announcements, which could be the catalysts for a turnaround in the SP as per the Feb operational and financial highlights:
- COVID ARDS expect to update the market with much more granularity in the short term major unmet need. Single trial would support an EUA
- Back pain expect to be working with strategic partner shortly. Confirmatory trial to last ONLY 12 months
- Remestemcel - L for aGVHD. Statutorily based on a resubmission fapproval is 6 months. SI expects approval in the second half of this year. The commercial team is in place to hit the ground running.
- Royalties in Japan keep increasing for aGVHD so expect this continue with next quarterly update
- UC and Cohns they will go back to FDA for larger trial based on the impressive preliminary data from the smaller trial
- Heart Failure greatest impact was in participants which had ischaemic or ischaemic diabetes. Discussion’s with the FDA are happening and and are in the process of a formal submission to the agency and they’ll be able to update the market in short order.
Hopefully this provides some confidence that the SP at these levels is temporary and the only way is up from here. We have previously been at this levels. Difference here is that with so much rich positive data, which was not the case last time we should never see these levels again IMO.
GLTAH
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