Just watched SI presentation at the Share Cafe Webinar. My key takeaways:
aGvHD:
* Coming quarter refiling
* Second half of year potential approval
* Small sales force as 50% of transplant centres in US
* Substantial reimbursement revenues (launch towards end of year)
* Japan seeing 30 - 40% adoption in market after 3 years
* Potency assay to predict clinical survival - new data shows this
* Very confident - resubmit data short order - review process 2 to 6 months
* Reiterated 9:1 ODAC vote - extra data requested around potency assays
IBD
* Current drugs on market cost about $60,000/year
* Update next couple of months further results
* Initial results outstanding
CLBP
* Most valuable opportunity - multi billion projected annual sales opportunity
* Second half of year to start CLBP trial
Interestingly didn't expand of CHF - intriguing - make of it what you wish. My thoughts probably because in discussions with FDA.
Mentioned extremely happy to have Dr Krause on board - asset for navigating first and subsequent products.
SI looks confident.
Good luck all!
MSB Trading 2022, The TurnAround, page-721
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