Post Hoc Analyseswhich has been peer reviewed from the NIH trial. The mean proportion of successful weans in patients with ischemic heart failure (n = 69) was 64% in theMPC group vs 43% in the control group (RR, 1.55; 95% CI, 1.01-2.36), …
Doc, also look at the supplemental appendixThere is a 0.02 p value against the ischemic pre specified sub group for reduction in GI bleeding. After four years of evaluating both the Phase 3 Dream Revascor and NIH LVAD Phase 2 trial , the Cardiology team at the FDA have most likely looked at the totality of the evidence in both ischemic sub groups in the aforementioned trials , as predicted in the Q&A of an earnings call by the CMO Eric Rose , who is an eminent cardiologist in his own right .
That’s the Eric Rose that wants to buy an additional 1.5m shares you may recall.
I believe that the FDA must be willing to consider using a reduction in GI bleeding as a surrogate endpoint for mortality which would facilitate an accelerated approval based on the results of this trial. Normally, a further trial would be warranted but when one considers this is an unmet need they are entitled to grant it if they are convinced of the science.
What is very encouraging is the successful weaning percentages. Remember many patients for LVADs over 65 years old have Grade 3/4 disease and baseline ejection fractions of just 20 which keeps them barely alive. When one considers that only 2 out of the 3 weaning exercises (taken in 2 month intervals over 6 months) were undertaken in this trial as many of the patients because of unrelated problems with pump thrombosis the results achieved by using Rexlemestrocel were pretty outstanding. Remember, failure to complete a test was registered as a failure regardless of the cause which disguised IMO an even better result. As an eminent cardiologist yourself , you are no doubt aware of the problems of driveline infections and small vessel malformations causing strokes , which is why 2 year mortality post LVAD use is still poor. If we can successfully wean off LVADS a significant number of patients over 65 years old it will revolutionise LVAD treatments. In any one year there are about 100,000 patients hoping for a heart transplant and over 65s do not get a look in when a heart becomes available . I have read studies where less than 5% of Grade 3/4 ischemics can be permanently weaned with similar ejection fractions. Maybe we will get further peer reviewed information which help explain the FDAs newly found enthusiasm? Someone pretty special must be happening…just like it did in HLHS. Once the clinical data builds up supporting Rexlemestrocel’s use in end stage ischemics, the obvious off label use is in Coronary Artery Bypass Graft operations for late stage ischemics…as much larger population with similar ethology . I understand that of the 400k CABG procedures completed annually in the USA ,about 50k late stage ischemics might be the obvious target population for an additional treatment of our cells. OP
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