@DocMcstuffins
Er Doc, the FDA have also just indicated in formal meeting notes that accelerated pathway options are available to Mesoblast for pursuing for two other therapies, one of them being end stage CHF and the other HLHS during that time period. or had you forgotten ? The share price was driven down by some larger players shorting and then subsequently participating in the placing. How do Australians feel about rogue operators spreading inaccurate bile before piling in themselves when they have been encouraging shareholders to sell at a low point ? Outrageous but very difficult to prove.
Mesoblast will require one more pre BLA meeting in the next few months for Rexlemestrocel before compiling its end stage CHF submission with accompanying manufacturing data in Q1/Q2 2025? That was definitely surprising to you… because you said it couldn’t even happen without another trial being conducted. Do i need to explain the size of the CHF market to you ? The current Share price is a joke. It doesn’t take a genius to work out that CLBP might also prove to be a candidate for accelerated approval on the basis that it can make serious inroads into dealing with the opioid crisis in the USA . Those anticipating having to wait 2-3 years for CLBP might also be surprised in due course, but that decision is in the FDA’s gift should Mesoblast apply. I suspect that Mesoblast has an embarrassment of inflammatory conditions which can be safely controlled by our multi factorial mechanism of action. Don’t get me started on those !
A somewhat poorly briefed l analyst on Seeking Alpha has just published an hatchet job valuation on Mesoblast based on a $250k total treatment cost for Ryoncil .When a similar first in class CART-T therapy for treating certain types of rare paediatric blood cancers was approved back in 2017 called Kymriah, it lacked long term mortality data and had some serious black box adverse effects but still had a sticker price of $475,000 I predict a price close to $700-750K per therapy for Ryoncil based on the fact that expert analysis shows a patient who dies with sr aGVHD has $1.8m treatment cost differential to surviving patients. (See below).
So Doc, I contend the fundamentals have changed, as a result of the FDA recognising “positive clinical evidence” in a Type B meeting on 21st February 2024 regarding the pathway to approval for Revascor …very .considerably. In my opinion accelerated approval for end stage Heart Disease would be worth many billions , OP
https://www.jmcp.org/doi/10.18553/jmcp.2021.27.5.607
https://www.pharmaceutical-technology.com/news/mesoblast-eyes-accelerated-approval-filing-for-heart-failure-cell-therapy/?cf-view
Please do not rely on the facts or opinions expressed in this post when making an investment decision.
Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-128
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