If the Doc really understood a very complicated subject he would...

If the Doc really understood a very complicated subject he would know that RCTs for aGVHD have been using patient stratification methodologies ( Glucksberg and IBMTR ) which are now proven to be far lessaccurate than the Magic Biomarker scores which have been back tested through meta data analysis involving thousands of patients . According to a podcast I have been listening to Dr Ferrera will shortly be presenting the results of thousands of patients data over the last five years whose clinical data has been reviewed on this basis . The superiority of soluble ST2 biomarker scores above 0.29 using the Ann Arbor algorithm classifications reflecting likely “non responders” is one of the greatest breakthroughs in demonstrating efficacy both as a prognostic and predictive tool. Basically , at all stages (1-4 weeks) it is more accurate than ANY other grading methodology used in RCTs ! This is a fact backed up in numerous clinical papers. When we match Mesoblasts clinical trial results with these ST2 ( MBS) scores we discredit the RCT requirement as being the only basis for approval.That was why Mesoblast undertook the separate analysis with MAGIC . This is a strategy which other biotechs have also recently adopted to overcome null hypothesis disputes. Basically , RCTs have been using panels of Best Available Therapies on the judgment of the trial investigator ( see Supplemental Appendix Reach 2 trial for Ruxolitinib Phase 3 trial ) . Whilst , I am on the subject did the Doc see how well Remestemcel performed in Reach2 when it was used as a treatment option ? I suggest he look it up ! Sorry it’s so technical, but I am sure the Doc understands the p values of the biomarker are superior to the clinical grading used in historical trials in this area. You have to keep up Doc . This was all covered in a peer reviewed study which was published on the 1st September 2021 in Nature . Mesoblast also submitted these facts to the ODAC Committee but I am afraid the expert practitioners understood what the FDA review team was unable to, which is why they voted in favour of it by 9 votes to 1.Since the date of the ODAC hearing the overall consensus regarding ST2 has become overwhelming. I will try to find the podcast so that you can hear how about most of the top 35 specialist teaching hospitals in the US and Europe in treating GVHD have all contributed to the meta analysis .




https://ashpublications.org/bloodadvances/article/3/23/4034/429584/The-MAGIC-algorithm-probability-is-a-validated