This is an excellent summary of recent events and clarifies some important points….John Hester is a sensible analyst ….what I can’t fathom is his inability to revisit the valuation post the FDA change of position . I have posted recently that the batch variability for Prochymal was caused by downstream processing not the cells themselves…a point which must have been obvious to the FDA at the conclusion of the manufacturing inspection at Lonza Singapore. Osiris never benefited from these upgraded processes at the new plant in Asia, as it sourced cells from another facility in the US. It has taken Mesoblast four years to identify the source responsible for the Prochymal variability …and then show a revised potency assay which could have been used at the time to weed out the less potent cells to prevent any reoccurrence.
To all those questioning Silviu’s competency , i believe he has found the proverbial “needle in a haystack” to prove he was right all along about his trial GVHD001. I recall the FDA experts at the ODAC meeting suggested using the latest machine learning and full spectrum integrated proteomic workflow analysis to show how proteins might have been altered during the MSC manufacturing process …in the understandable expectation it would provide answers relating to the mechanism of action for Ryoncil . I think Mesoblast would have had to oblige them by providing all this additional clinical work.
The chart below suggests that dark forces have been at work “selling the news”with naked shorts in the US. Whilst I am confident that days traders and arbitragers also payed a significant role , I think it unlikely that 70m ADS /700m equivalent Aussie shares could have been traded on the day of the announcement. According to the ADS registration agent J P Morgan there are only 18.47m shares outstanding in ADS form, half of which i believe are held under various nominees to the benefit of Dr Gregory George. IMO someone has tried to control the share price after two extremely positive announcements…they will have to buy back soon. I rather fancy the start of the P3 blockbuster CLBP enrolment to focus peoples minds on how large the potential for this share really is as a platform technology. It would not surpirse if we rise tenfold over the next 12-18 months.
Please do not rely on the facts or opinions expressed in the above post when making an investment decision. OP
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