@R2r11 I am afraid it is you that needs to smell the coffee.
1) The futility analysis for the Revascor CHF trial , including safety and efficacy , occurred after 50% of the patients had been enrolled and was after 25% of the primary MACE event endpoints had occurred. It cost US$14m to conduct and resulted in a decision to continue the trial. The FDA required five year safety data so the trial continued with no reference to the unblinded data, which I understand was seen in censored form by the Company . Would the Company have continued if the data was poor ?
2) There were a total of 9 interim analyses, every six months and a further one at the conclusion of the trial.
“
DMC reviewed available data from the 566 randomized patients, including components of the trial’s primary and secondary endpoints, and all safety data. The results from this pivotal trial are expected to be read out by mid-2020.”
https://www.biospace.com/article/releases/data-monitoring-committee-completes-final-scheduled-review-of-mesoblast-s-phase-3-trial-of-revascor-in-advanced-chronic-heart-failure/Let me help you here , if the DMC is tasked at the commencement of the trial with ensuring safety and futility, how do you expect the trial to fail once it has concluded with all interim analyses passed by the DMC ? Please explain your negativity . I am all ears .
I could provide you with several other reasons why people should be optimistic...indeed I believe the crucial point now, is not, have we had a positive result ? but the
quantum of that
improvement . Remember , in the Dream HF-1 trial, 80% of the patients have similar ischemic profiles to the seventy patient subset in the LVAD trial , who showed such a dramatic reduction in hospitalisations (which are correlated to mortality).
Furthermore ,please explain to all of us, why at 6 months there was a :
“Dose-dependent effect seen on left ventricular remodeling, with 150 million cell dose (MPC-150-IM) showing greatest effectvs.controls”
Page 24 of this slide presentation should help you .
https://www.jefferies.com/CMSFiles/Jefferies.com/files/Mesoblast.pdfDo you call that a coincidence ? It just happened to occur in that 15 subset group with the highest dose that did not have a SINGLE hospitalisation. Please, i have had enough of all this deramping.
I will wait to hear your explanations to the points I have just raised. I want to hear them ...because I want everyone that being frightened out of their shareholdings to see the motivation behind so many posters on this website.
Step up or ship out !
Please do not rely on the facts and opinions expressed in this post when making an investment decision . OP
(20min delay)