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Wednesday, April 01, 2015 5:36:57 PM
Other thing would be some guidance on the plan for sepsis. It was end of 2013 when there was an update on dosing study (28 patients), the total number is 50 patients according to the new website. Even with 28 more patients, the update they gave was very vague, so I'm not expecting much. The best thing that could come out of it is some guidance for a comprehensive study.
This dosing study was supposed to be a quick study...before doing a real study, but it's dragging out way too long. The primary end point is 28 day survival, pretty short relative to other programs that are moving fast in pharma. In pharma, companies are always trying to find ways to expedite approval (break through therapy, buying priority review vouchers). I'm really not sure why they are dragging their feet with generating clinical data. Oncology trials that have longer end points with hundreds of patients are finishing faster than this dosing study...Regeneron/Sanofi started multiple phase III for their cholesterol trials in 2012 that are already finishing up. If this is truly a blockbuster, they are not acting with that kind of urgency. Pharma companies have to be more cautious because a lot of drugs fail on safety, this supposedly has zero safety concern, so why not just go for it.
Also...side note, can someone explain reimbursement in Germany. In the US, hospitals would love another therapy you could tack on to bring in more revenue. If it's really only $500-1500/patient on cartridges, why would you not just add it in case there is an effect. Do you get a lump sum for treating a patient on disease X, or do you get fee for service.
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