Ann: FDA Grants RMAT Designation for Rexlemestrocel-L in CLBP, page-126

The current downward share price movement is a shakedown. In my opinion, Mesoblast appears to have totally turned around its relationship with the FDA and is about to reap the rewards of its labour. Over the next 12 months , I believe the topics discussed on these threads will move to SNDA’s, off labels sales opportunities, valuations based on percentage probabilities of success on various blockbuster indications….and partnerships.

As a Company, which will burn cash probably for up to the next 3 quarters, Mesoblast may well raise additional capital by the end of Q2 if it wants to accelerate the pace of clinical trials in additional indications without dilutive partnering alternatives . Alternatively, if valuations remain subdued I quite fancy Silviu to pull off some form of less dilutive royalty deal. When the markets accept that approval for Ryoncil is almost certain ,..(barring unlikely failure of the manufacturing inspection at the Singapore site of Lonza)…the share price may well become parabolic, as it did a few years ago . The specific catalysts for this are many and varied, but if the Company receives FDA acceptance of its resubmission in approximately 6 days time and a 6 month PDUFA date is set…..I will probably be all in. That is the way a game of poker is played. You wait for a hand of overwhelming odds…recognising inherent risks remain, but you play your hand based on the probabilities..

If you blink, you may well end up kicking yourself for missing a paradigmshift taking allogenic mesenchymal cell therapy into mainstream clinical use …but please remember that biotechs are not for widows and orphans. I believe equity markets have grown weary of missed filing timelines, poorly chosen primary endpoints and dilutive capital raises..but therin lies the opportunity.You may loseall your investment to another unforeseen black Swan event…however, i will continue to play what I believe to be, incredible odds !!! Good luck to all and I look forward to expanding on the comments above in due course. OP


Please do not rely on the opinions or facts contained in this post when making an investment decision .