@bruce_w92 @BiotechElmo@crist_phd@BillMiller32 Not a fan of cause. Hard to tell w little info, from Bofas report issues seems fixable. HSCT-TMA severity, no options and Narsoplimab efficiency and safety it would be more than odd if FDA all of the sudden dumbs the drug. At these prices a little to late to sell, so I'm waiting.
@Quantisnow@jpmorgan FDA ended the study due to impressive response rate, target 15%, Narsoplimab got +60% respons rate.
Lack of comparator? There is no treatment today only management that dosent work. Best case 15% response r... https://t.co/R3FXntVsAt
@flora_peyvandi @aHUSUKvoice #Narsoplimab FTW ๐ฅ
Only complement inhibitior that addresses the crosslink between complement and coagulation ๐
https://t.co/1o1AUjVPPn
An increase in #complement activation has been observed in #GVHD and #HSCT-TMA, and rates of overlap between steroid-refractory GVHD and HSCT-TMA have approached 80%. The presence of both impacts clinical outcomes. #TMA#transplant https://t.co/dv7R38L4zF
@zachiscards Where do you see any prayers? Scamming less intelligent investors and potential regulars to believe they have a covid19 treatment, now that's disgusting ๐คข
@andrewkwil@TOWiU2 @anflan88 @SnackBioTech Hard to tell from a slide summary. Fact is a paper detailing the pivotal has been submitted for publication and will be published. Lot of answers will be provided. Answers FDA already has.
@andrewkwil@TOWiU2 @anflan88 @SnackBioTech Yes Andrew these slides are what Omeros submitted to FDA in the BLA. Fact are we don't know what FDA wanted and what Omeros answered.
@RWMaloneMD Why did you enter the study then? Whole idea is to build on a backbone of drugs that have proven to work.
But you run a RCT alone vs SOC and show the superiority of your wonderdrug..
@TOWiU2 @anflan88 @parrotfishing@Rajt1111 No SOC today, you can โธ the CNI(causes endothelial damage) but not effective & risk of GVHD โฌ๏ธ. Then there is a bunch of stuff that doesn't work well: steroids, c5i, plasma exchange ect. Reason why Narsoplimab only needs to beat 15% response rate.
@SnackBioTech Of course but this is TA-TMA, ultra orphan condition and w 90% mortality rate without treatment in the high risk setting.
And was it by a factor 3 or 4 Narsoplimab outperformed the FDA agreed threshold of approval?