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@dachopper great post (it is why I follow you), question for...

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    @dachopper great post (it is why I follow you), question for you. We have had an amazing announcement of the CLBP trial. The biggest boost to a blockbuster therapy that will launch this company. As @otherperspective (from memory) posted, it is unusual in that they did not demand a composite. So my question is, would this have been agreed if OTAT were still to “rule”?
    Reading the thoughts of posters and timelines given by the company, I assume meeting has been held. If negative like before the CLR they would have announced it. If negative to avoid another “class action” (which this time imo would not have been a frivolous shade throwing stunt) they would have had to include the caveat of agreed potency assay as part of that trial. Clearly the minutes (are they in the same format as other departments?) have not come through and Covid and Xmas may explain why they are hoping to update before the end of the year as they wait for these to come through.
    I think we all agree that OTAT approval is the launch pad. I think we have been allowed to park up our record on that pad. The CLBP trial is the first. Fully expect however that SRGvHD to beat it to actual launch. Next clue will be the update on Heart, again following @otherperspective and others posts, fingers crossed that the word RMAT will be in there. Covid Ards, I had a very good reply from a Turtle when posting at a “sub station”. In essence again this has been the view of others who I follow, we were never going to be “The solution” to the problem. However given the sheer numbers, variants and speed of infection, plus those who choose not to vaccinate. There will be (as with flu) a sufficient number ending up in CU’s. Here in the UK, are government are threatening another lockdown on the premise that we have to avoid over running these beds. It costs billions each time. Money we don’t have. Therefore as we will have clearly identify in the next trial the “sweet spot” and dosage required (let’s not assume we can’t help over 65’s) to reduce the time they spend in ICU and save lives. We will remain a high value treatment with high value income. The cost of lockdowns and political requirements of avoiding the deaths, imo outside cash to fund this trial will be found.
    Novartis will not be the first company to overlook a Diamond. Someone mentioned the company who did not sign the Beatles. Well I would rather highlight the companies who could have brought Google for a snip. One of whom was Yahoo. Remember them?
    I think OTAT has a great big tick against it. The data we already have has shone through. The FDA are working with Mesoblast to bring these therapies through but have established a high bar for others to follow. We have the patents. As fund managers slowly understand this, you will see that pressure of buyers take the ball away from those who can currently control a small cap company with their shorting antics.
    regards
    Yelrom
 
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