@E300@Anjo-RochTo hear such kind comments makes the hours and hours of researching and validating information so much more worthwhile. My children may not agree, however ! HotCopper has brought me together with an online family whose contributions make me smile on a continuous basis. We cannot help but be touched by the bonhomie of
@Wilba32 and
@reginaldp, grounded in reality by
@col69, or bedazzled by the wisdom of
@Phaedrus and
@stockrock Then we have the excitable intra day commentaries of
@ddwn or the more sober morning call from
@antibody with the Nasdaq trades. How wonderful that someone in our community selflessly devotes time to do that US trading report every day, especially as there has been a consistent transfer of ownership over to the USA, where ADS receipts now account for almost 30% of the share register according to the J P Morgan ADR Register.
@dachopper has done a splendid job holding the fort against the hate mob and going further back who could not be impressed by the salient in depth observations of Left-E, the Turtles and ECoool backed up by the cutest of black labradors
@The Yankee.
Mesoblast has been blessed with some great supporters…not least of which are the former fund managers at M&G and Capital who supported the Company over so many refinancings. Without their support I seriously doubt the Company would have survived. Few of you will understand that the patience and fortitude shown by the fund managers of those institutions who believed so deeply in the science but the timelines for regulatory approval have been cruel , twisted and extended, as the true mechanism of action for MSC’s unveiled itself. Mesoblast has hardly helped itself with the choice of primary endpoints, or a failure to properly capitalise itself to withstand these constant delays. Despite this criticism, anyone who interacts with Prof Silviu Itescu is blown away by his mastery of his brief and his exemplary work ethic. This is a man who is a total workaholic but he is much more than that. Time and time again I am touched by stories of his huge compassion in offering to help individuals in a desperate situation to cling on to life. When, Covid arrived he accepted the call to arms, initially saving many early patients lives at Mount Sinai in NYC from an horrific death. What is remarkable was that without the introduction of Dexamethasone to the control armamentarium, our Phase 3 trial might well have met its primary endpoints as it had already progressed beyond two interim futility tests. People should remember that the control arm would never normally be allowed to make such changes mid trial and we never benefitted from the fact that our therapy combined with Dexamethasone was arguably the best solution to ARDS. What an achievement from the whole Mesoblast team that we can all be proud of.
The Phase 3 Chronic Lower back Pain trial, is another travesty, with practitioners ignoring a clinical trial protocol in the best interests of their patients and weaning a significant percentage of patients off opioids early in our cohort, confounding the efficacy results. What was the response from the FDA ..to ask for another Phase 3 trial. With half of opioid deaths in the USA attributable to CLBP, is this really the best way forward? Thank goodness a practical approach has emerged from Operation Warp Speed and credit must be given to Peter Marks for his top down approach to reforming the process for accelerated approvals…which is only just permeating down to our regulatory pathway to approval, now Nicole Verdun heads up FDA, CBER, OTP.
How lucky are we also to recruit Philip Krause formerly from the FDA to assist Eric Rose as CMO whose stellar career as a Heart Surgeon is so highly respected.
I also dob my cap to our external principal investigators at the coal face, such as the wonderful Dr Joanne Kurtzberg at Duke Univ and Dr Emerson Perin at THI. I had the honour of speaking to Dr Perin a few years ago when doing my due diligence…what a caring physician devoting almost his entire life to the pursuit of a treatment for Chronic Heart Disease, the number one killer of mankind. Lastly, let’s recognise the scientists like Dr Paul Simmons whose original IP helps to drive this Company forward ,supported externally by the late Arnold Kaplan, the grandfather of MSCs who recently passed. Prof Levine at the MAGIC Consortium has also been instrumental in our progress in developing validated biomarker algorithms that have proven the efficacy of our sr aGVHD therapies beyond question.
So
@Anjo-Roch, back to that drink. We have a lot of toasts to make… some wonderful contributions to acknowledge… but they will have to be put on ice whilst we sit nervously on the sidelines watching what will hopefully be a successful BLA resubmission for Ryoncil . Like many of you here, I also suffer from conditions that could be treated by MSCS. I have learnt so much from so many of you all and I can’t say the journey has been easy financially but finding the inflexion points for “first in class” therapies is more akin to discovering the gold at the end of a rainbow. I believe Mesoblast is the real deal. Post approval , the market capitalisation of this Company should swell enormously as people wake up to the range of inflammatory diseases which can now be treated safely and effectively….surrounded most importantly, by over one thousand patents.
I will try to make it to this year’s AGM , but it is held many thousand of miles away from where i live. I would love to put faces to names and thank you for your contributions. Let’s face it, we are a cult craving respectability
We never intended to sign up for this torture in the first place. OP
Please do not rely on the facts or opinions expressed in the above post when making an investment decision. Biotech shares are extremely risky.
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