Originally posted by taylorstjames:
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Some crucial takeaways.1) Still much looking forward to the FDA approval. Beyond GHVD they are looking at other indications!2a) On GVHD - Hospitals can have Rem-L STOCKED day after approval. Looking at ~15 hospitals (as they do 50% of BMT)2b) On reimbursements from insurance companies - starts DAY AFTER APPROVAL We already have inventory, product is already made , and I don't see any reason why this product won't be used ASAP on FDA Approval "3a) On C-19 ARDS trial interim results - Again, reiterated the case that the MOA of C-19 ARDS is very similar to MOA of GVHD. Just look at the compassionate use results in Mt Sinai!3b) On the 30/45/60 interim results - "Y ou're right that the interim analysis was just performed in the first 90 patients and we flew through that . The DSMB recommended that we continue with the trial... "3c) On early stoppage - "We are focusing on completion of the trial and being in a position to present all the data to the FDA and have a potential label extension for Ryoncil "3d) On Australia - Ethics approval = several hospitals in Melbourne and Sydney that will take part in the trial4) On CHF & CLBP - "Both of these indications are really blockbuster unmet needs "same MOA of inflammation Both readouts will happen 4th Quarter this year .major heart failure company 5) On scaling up and COGS and QC - already in place to increase production to meet need for C-19. proprietary media using recombinant growth factors to increase yield by 5x-10x .6) On capacity to ramp up - they've been very judicious in terms of pre-launch capex (big pharma usually 18mths pre-approval), only invested 6mths in advance.a) Mentions that - sales force is ready and 12mths worth of inventory is ready for launch 7) Capital - happy with capital position8) On strategic partnership - Expects increase in royalties and also increase in revenue from strat partnerships
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On GVHD - Hospitals can have Rem-L STOCKED day after approval.
(20min delay)