Another good summary from a member (left-e) over at US Yahoo message board. Hope they don't mind me sharing.
https://finance.yahoo.com/quote/MESO
"I agree, yesterday's move was likely fueled by the CEO's presentation on Wednesday. He didn't give much new in content, but he underlined the company's strategy remains on target, always a relief in biotech. Perhaps the market is waking up to the fact that the product now labeled Ryoncil could get FDA approval anytime in the next few months. It's already approved in Japan and there's a wealth of trial data going back years documenting its safety and efficacy. The fast track status and rolling review into the final admin module plus the announcement of an approved brand name suggest preceding major hurdles (trial data, manufacturing) have been cleared. And we're in an environment where the FDA has been making earlier than expected announcements, Amarin's Vascepa is a recent example. This is one where it's wise not to be sitting on the sidelines when an announcement comes.
In medicine Ryoncil is a big deal. The FIRST FDA approved allogenic stem cell treatment. Allogenic meaning it's a transplant from one human to another. We could really say it will be the first FDA approved stem cell treatment. Because to date the FDA has only 1) ignored, 2) tolerated, or 3) banned. They've told clinics what cannot be done. And in some cases that has included banning certain autologous stem cell treatments, ie treatments using an individual's own stem cells. So, this is a breakthrough... and notice he used one very sweet word in his presentation: cure. This is a treatment that leads to the cure of an illness with a 90% mortality rate in children. No ongoing treatments required. A cure of an illness provoked by bone marrow transplant from a matched donor.... that can now be treated... by of all things a second transplant of MSC's from the bone marrow of an unrelated donor. Pretty incredible stuff. Meanwhile treatments with small molecule inhibitors (names ending in -ib) are falling by the wayside due to toxicity (Incyte's ruxolitinib / Jakafi) or lack of efficacy (Incyte's itacitinib).
He talked about patents. Mesoblast has over 1000 patents in its stem cell therapy estate. It's a reason I think FDA approval will put them in play with big pharma. Deep pockets to defend against big players who will invariably step on the patents. My opinion. Meanwhile ph 3 results are pending on the spinal and cardiac products, pivotal in the latter case meaning another approval is on the horizon. 2020 should be a good year for MESO. Careful hedging or selling it short, and many thanks to whomever sold me those $5 calls in November. Much appreciated, it brought me out of message board retirement. GLTA".
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