MSB 1.02% 99.0¢ mesoblast limited

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  1. 258 Posts.
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    Great question. I have included a snippet of the Appendix 4C Quarterly Activity Report ending 31 March, 2022 when we heard this news. If we take the case that they supplied data for the pre-specified high-risk groups that showed the greatest benefit (diabetics and/or ischemics) on 31 March, 2022 then technically the time-frame set by the FDA is 60 days to review an Accelerated Approval request, so we could know any day now. However this time frame of 60 days to the best of my knowledge only applies if a manufacturer makes a request for an Accelerated Approval Pathway. Unfortunately for us shareholders this time-frame may not apply because it is my understanding that it was the FDA that asked us to provide data on the target population with the greatest treatment benefit (i.e. it was not us to request an Accelerated Approval Pathway - so does the 60 days still apply?). Either way, I would expect news could drop any day now or in the coming weeks. I assume we would know by the end of July unless more detailed discussions behind the scenes continue around Manufacturing / Quality Control...


    https://hotcopper.com.au/data/attachments/4477/4477147-997e981ac71b951902aa99c96a77bfe4.jpg

 
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