@PledgeSo even though the FDA PLI Manufacturing Report for Lonza Singapore showed extensive lot release testing without any known issues , the FDA still requires its
own “routine
lotrelease” procedures
before batches are
released in the USA to patients. So please spare us the lectures because you are clearly out of your depth. Mesoblast can now build Ryoncil inventory storage in the USA in advance of patient demand, but for the first few patients there is likely to be very minor batch testing delays before release to the distribution channel..therefore some aspects of the procurement process can be held up temporarily by FDA paperwork for lot release testing.
Mesoblast has clearly knocked the ball out of the park with regards to reference pricing for Ryoncil and has already identified, in treatment refractory Crohn’s Colitis, a major new label extension opportunity to pursue worth multiples of sr aGVHD but the doom merchants continue to peddle their filth. Personally, I believe that Mesoblast can achieve a
runrate of close to US$100m of sales within four months…by treating just six patients a month . When Medicaid reimbursement is fully available in about six months? that number could double again just for severe grade paediatric patients .
I can tell you one thing. In my opinion the shorters will not be anywhere to be seen when the penny drops. All Silviu has to do is announce he has treated several patients and the bear case will be exposed as posterior fluff !
https://www.fda.gov/media/185192/downloadPlease do not rely on the opinions or facts expressed in this post when making an investment decision .
(20min delay)