Hi A.
Couple of questions and my thoughts are as follows:-
(1)
ASX announcement 15/11/2011:-
Dr E Perin :Texas Heart Institute - Medical Director, Stem Cell Centre.(note: at the time the follow up periods was 22 months)
Dr Perin is quoted as follows:
......."These clinical findings are the first using any cell therapy in heart failure patients to show a concordant positive effect on clinical outcomes, cardiac remodelling, and functional capacity, the three key parameters in congestive heart failure. Together, they indicate that a single 150 million dose of Revascor™ may significantly reduce both heart failure hospitalizations and death in these very sick patients who have such a poor prognosis despite maximal existing therapies,” Dr Perin said.
”Based on their defined product characterization, batch to batch consistency, immediate availability, and lack of clinically relevant immunogenicity, MPCs appear to be an ideal cell type to provide a new level of patient care in congestive heart failure. We look forward to progressing the Revascor™ clinical program into Phase 3," Dr Perin added "....End of extract
Also - as mentioned by MSB in various presentations, at 3 years plus there been no MACE events. Also I suggest you ( and all holders) have a look again at Maxim Report on 28th January 2013 which hosted a Cadiology Dinner with three world-class Cardiologists and key opinion leaders: Emerson Perin MD, Kenneth M Borrow MD and Warren Sherman MD.
The "experts found the high-dose data absolutely compelling when considering all the parameters of cadiac health and cardiac MACE".
(2)
Regarding the 125 patient interim analysis - my views are quite the opposite and shows confidence by TEVA with the MPC technology.
In reading various analyst reports (over the years), the interim analysis was as expected and part of the IND strategy/request by Mesoblast/TEVA. In fact, I am fascinated that the meticulous FDA would agree to such an early review point(and not 500 or 750). So IF the readout from an early interim analysis, recommends continuation of the Study, then (in my opinion) TEVA and MESO have a business that has shifted gears and lots of options and food for thought (prior to final P3 heart failure study results in 2016/17?).
In following the Mesoblast story over the years, I am getting the picture that when they plan a study or engage in a transaction (CEPH; LONZA; Osiris), its been attentively reviewed and considered before committing to.
In any event , I wish you and all holders the best of luck and always DYOR.
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