MSB Trading 2020 - a new dawn, page-12638

NEXT - just went and checked the primary endpoint for BACK- CLBP, to make sure it is plain and simple. Seems to be just that, is there a reduction in pain as measured by a visual analogue scale and the Oswestry Disability Index. Then was any further treatment required on the disc.
This is subjective to each patient and requires their input in drawing a pain scale and answering a detailed questionnaire re pain management by taking/not taking pain relief medication and how or if their daily life is affected by their disc.

 Primary efficacy endpoint agreed to withFDA:
– Overall Treatment Success Composite at both 12 and 24 months as measured by:
o At least 50% reduction from baseline in Visual Analogue Scale (VAS) pain score at both 12 and 24
months post-treatment; and
o At least a 15 point decrease from baseline in Oswestry Disability Index (ODI) function score at both
12 and 24 months post-treatment; and
o No interventions affecting the treated disc through 24 months

PHASE 2 FAVOURABLE RESULTS BELOW

Phase 2 Clinical Trial – 36 Month Results
MPC therapy provides durable results through 36 months
 Over 36 months:
− 82% of the 6 million MPC group who achieved the Phase 3 primary endpoint composite
over 24 months maintained treatment success1
− 86% of the 6 million MPC group who successfully met the Phase 3 pain responder criteria
(50% pain reduction with no additional intervention at both 12 and 24 months) remained
pain responders2
− 92% of the 6 million MPC group who met the Phase 3 functional responder criteria (15-point
reduction in ODI and no additional intervention at both 12 and 24 months) remained
functional responders3
 There were no significant differences in safety events cell-treated patients and controls over
36 months


Back results are imminent, no reductions in overall hospital visits, no 43% reduction in mortality requirements.

I'm backing this one in ( pun Intended).

Reg


The bottom line is that the drug did work but the FDA didn't like the single arm trial.
The heart drug works spectacularly, yet to chat with the FDA about 60% improvement in mortality rate plus reduction in strokes and heart attacks
Covid Ards trial no longer recruiting but continuing, with Novartis potentially commencing normal ARDS trial at their expense.


Haven't sold a single share