MSB 0.72% $1.37 mesoblast limited

The below post is not mine. I came across it last week on Yahoo...

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    The below post is not mine. I came across it last week on Yahoo stock forum posted by Left-e . I am sharing it as I found it to be an informative and timely reminder of MSB objectives with gvhd.



    "As mentioned by others, getting FDA approval will be a key event for both Mesoblast and Osiris. We know that Restemcel-L has fast-track status with the FDA, that phase 3 results are compelling, that market penetration has been good in Japan where the product is already approved, that Mesoblast has had multiple meetings with the FDA in preparation for a BLA submission (suggesting rolling review), that Mesoblast has hired a Sr VP for Commercialization and is reportedly building a sales force in the US., that the partial Gov't shutdown is now partially resolved, and that the company has cash on hand and 3 different credit facilities to launch the necessary marketing program while continuing to develop its other products. The “Loan facility with NovaQuest Capital Managment” mentioned in yesterday's filing is of interest. Mesoblast received a $40M loan commitment from NovaQuest Capital back in June and drew down $30M at closing. No interest payments are due until FDA approves and Mesoblast makes a first commercial sale of Remestemcel-L. Moreover, the loan is subordinate to Mesoblast's senior creditor Hercules Capital. Talk about putting $30M at risk. NovaQuest is a spinoff of the CRO Quintiles Transnational and they know their way around clinical trial data and the BLA filing process. Interest rate is high, but I don't think NovaQuest would have agreed to such loan terms if they weren't ultra-confident that FDA approval is forthcoming. No doubt they'll be actively monitoring the submission process. Hard to tell exactly when approval might occur, in my mind it's “anytime now”. This is a big deal in medicine - the first off-the-shelf allogenic stem cell product, a very special gift of life from one human to another. Win-win for both companies and the culmination of many years of R&D effort."
 
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