Very few institutions have the skill sets to evaluate this Company at this stage of its development. Those that attempt to have been continuously burned by a regulatory system that preserves the status quo. Some of the biggest breakthroughs in medicine have occurred by chance findings as a result of the FDA sending applicants on wild goose chases which prove the complete opposite. Case in point SGLT2 inhibitors and GLP1 agonists .
Meanwhile there are still grandfathered products on the market like talc and deodorant which are now finally being examined for some pretty horrendous potential side effects.
I have seen Mesoblast survive by doing just enough to scrap through pushbacks mainly by relying on its existing shareholders for funding when faced with probing questions from perfectionist scientific panels on the FDA, who established efficacy and safety long ago , but appeared determined to drill down to the nth degree on learning about MOA. Rather than regulate , it appeared that some on OTAT even published research on how they could do improve processes and pressured the Company into evaluating their own IP.. enough to bankrupt any company .. and you can’t argue with your regulator ! Efficacy was obvious long before Mesoblast revealed four year mortality data for GVHD001/2 …you would have expected the MAGIC biomarker algorithms based around ST2 to have done the trick a long time before. What is particularly galling is the seemingly easy ride to approval afforded to Incyte’s Ruxolitinib when duration of response and toxicity are taken into consideration.
Some in the US government saw that big pharma had, by and large, thrown the towel in on large R&D spending that has left over 50% of BLA approvals now coming fron small biotechs which are then snapped up for spare change by larger companies not prepared to subject themselves to the regulatory fiasco . Finally the FDA is being more sensible in interpreting accelerated approval powers now they have added appropriate safeguards on misuse .
Were it not for two institutions bankrolling Mesoblast for much of the last decade and the acumen of a proven commercial entrepreneur in the form of Dr Gregory George , Mesoblast would probably not be in existence. Ironically, all the delays will have cost the US healthcare system a small fortune . Mesoblast is now in a dominant IP position with whole hosts of clinical data which has supported much higher reference pricing. Silviu has yet to reveal his new manufacturing strategy but substantial productivity and potency enhancements from future generation products are about to raise the bar even further against the competition. Now efficacy of over 70% is proven in severe grade acute GVHD, the costs of powering a competitor trial solution in such a small patient population become exorbitant.
Ryoncil has been introduced to the commercial market and most investors in Australia are asleep at the wheel.. the last piece of the puzzle .. sales and profits are about to wake them up ! The antics of the short sellers are disguising the incredible progress made in the last twelve months. Regardless of progress, they attempt to crash the price in front of fundraisings and then hope to by back during the dilutive fundraising. This time , I believe they have overplayed their hand. I believe Ryoncil will be cash flow positive within a few months and substantially profitable within six to nine months on a stand alone basis. If an adult trial is completed successfully in Rux refractory patients sales of US$ 1bn are achievable within 3-4 years. To think that analysts guided reference pricing at only $250k per paediatric treatment only four years ago ! An average nine dose treatment is now around US$1.5m !
In my opinion, Mesoblast is about to rip . If Ryoncil can produce these type of revenues from one orphan indication . Just imagine what lies in store . I never thought we would sit at these absurd valuations on the eve of the Type B meeting for cardiac but I have increasing my exposure as the shorters play their game of chicken. OP
Please do not rely on the facts or opinions contained in the above post when making an investment decision.
MSB Price at posting:
$1.68 Sentiment: Buy Disclosure: Held
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