These products will be approved based on the overwhelming totality of the evidence. Here is just
some of the evidence they already have.
Source:
3A594714_MSB.pdfHave you downrampers considered :
GvHD control arm survival rate ( MAP > 0.29 ) 10 - 35% survive at 12 months
Remestemcell patients 70 - 80% survive at 12 months
GvHD protocol 280 patients control arm ( placebo ) 54% survive at 100 days
Remestemcel patients 79% survive at 100 days
But the down ramping cult, don't acknowldge this improvement in mortality, and refuse to acknowledge that this trial did achieve it's primary end point.ARDS trial respiratry function improvement over 30 days ( under 65's )
Standard of care 49% improvement
Remestemcel 68% improvement
ARDS trial 60 day all cause Mortality ( under 65's )
Standard of care 58% survive
Remestemcel 74% survive
But the down ramping cult, don't care about improving mortality for Covid in under 65's do they......Ulcerative Colitis and Crohns Colitis trial
In Controls, fecal calprotectin levels increased from a mean of 330, to 505 and clinical responses described as poor or unchanged.
Remestemcel treatment resulted in reduction of calprotectin, a validated biomarker of disease activity, from mean 231 at baseline to 67 at 3 months,
indicative of remissionThey have not put their collective downramping powers on these results yet ..... but they will, it is coming for sure.Back pain Trial ( entire population )
Controls mean change from baseline VAS pain score, 19 points at the 3 year mark
Remestemcel mean change from baseline VAS score, 25 points at the 3 year mark
Back pain trial ( Treated within 5 years of first diagnosis )
Controls mean change from baseline VAS pain score, 18 points at the 3 year mark
Remestemcel mean change from baseline VAS score, 38 points at the 3 year mark
Back pain trial ( Opioid reliance reduction)
Controls mean change from baseline opioid use , 8 % reduction at the 3 year mark
Remestemcel mean change from baseline opioid use , 28% reduction at the 3 year mark
But the down ramping cult, don't care about reduction of lower back pain, in a Chronic Lower Back Pain trial do they......CHF time to FIRST event Cardio Vascular Death, non fatal MI or non fatal stroke ( entire population )
Controls 34.9 % had 3 point mace at 2000 days
Remestemcel 22.8 % had 3 point mace at 2000 days ( 33 % reduction of 3 point mace vs controls )
As requested by FDA
CHF with CRP > 2, diabetics or MI patients,
Controls 39% had experienced 3 point MACE within 2000 days
Remestemcel 19.6% had experienced 3 point mace within 2000 days
But the down ramping cult, don't care about reduction of cardiac death, non fatal stroke or non fatal heart attacks in a Chonic Heart Failure trial do they......That is why the incoherent downrampers are members of some crazy cult. As if their brains are quantam entangled and when one crazy starts going off about the earth being flat, the other seven are drawn into the spooky action at a distance.
Maybe Einstein was observing downrampers and not atoms after all.
Sooooo much evidence..... all pointing towards approval.
(20min delay)