MSB 5.50% $1.38 mesoblast limited

Ann: DSMB Recommends Continuation of Phase 3 COVID-19 Trial, page-239

ANNOUNCEMENT SPONSORED BY PLUS500
ANNOUNCEMENT SPONSORED BY PLUS500
CFD TRADING PLATFORM
CFD Service. Your Capital is at risk
CFD TRADING PLATFORM CFD Service. Your Capital is at risk
ANNOUNCEMENT SPONSORED BY PLUS500
CFD TRADING PLATFORM CFD Service. Your Capital is at risk
  1. 2,059 Posts.
    lightbulb Created with Sketch. 319
    Defining:
    interim analysis = The analysis of data in a clinical trial comparing intervention groups at any time before the formal completion of the trial, typically before recruitment is
    completed.
    overwhelming efficacy =
    Clinical study has shown that the predefined stopping boundary has been crossed and the candidates primary endpoint met.
    I know the prelim data was shown to be very successful = 75% of patients off ventilation and discharged from hospital, but in reflection it seems the sample size is the real issue to extract a P value there needs to be a control group= is that which is blinded to treatment by placebo/candidate.
    While the 1st prelim analysis is mostly for safety and efficacy - this was already a given due to product candidate being equal to Ryoncil [clinicals already proved safety]. The main decisions when first interim analysis from sample group is = Trial stop/continue for Safety then results from first analysis show no benefit = Trial stop/continue for Futility.
    Given that the initial Mt Sinai hospital results would have been a defining "overwhelming efficacy" they must be discounted as no control group as compare to. I looked up a couple of P3 trials that were stopped early and looks like 2nd interim is the point where the patient sample size is enough to give a true picture of the P value analysis of treatment vs control group.
    So it has been decided probably on the grounds that the group sample size @ 30% is too small to show the endpoints being met and we have a better chance that @ 45% or 135 patients the 2nd interim will provide the necessary key endpoint analysis. All in all it was a green light and a nice follow up to the announcement of Aust inclusion of patients to be treated with Remestemcel-L. 2 green lights in a week that shows the volatility in markets and the virus are not going away anytime soon.
    Dips under 5 bucks well theres opportunity knocking but Nasdaq didn't boost MESO.
    Ref
    https://www.ahajournals.org/doi/pdf/10.1161/CIRCHEARTFAILURE.111.965707
    https://www.ema.europa.eu/en/documents/presentation/presentation-sme-workshop-session-4-statistical-considerations-confirmatory-clinical-trials-ii_en.pdf
 
watchlist Created with Sketch. Add MSB (ASX) to my watchlist
arrow-down-2 Created with Sketch. arrow-down-2 Created with Sketch.