Ann: Trading Halt, page-509

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01/10/20

22:25

Post #: 47791580
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Originally posted by mja ↑

Analysing the situation, the first trading halt overnight in the US 6 minutes into trading was likely precipitated by a statement/ query from the FDA. The fact MSB did not go into trading halt until 10 min before ASX open. Points to the fact Mesoblast management were waiting on information/ reply from the FDA and thought it could come at anytime, and they would then be able to make a release to the market and go into normal trading. However, a reply was nor forth coming from the FDA or the FDA needed further information.

My impression, is the FDA wanted clarification of an issue. MSB managment provided the requested information, and considered it would be routine and they would be able to open up on the ASX with good news. It appears some issues need to be worked through on Thurs/ Fri US time before FDA approval is granted. This is likely ongoing formal monitoring of response in paediatric patients treated for acute graft versus host. And correlation of some of the remestemcel markers with clinical response, to provide ongoing batch validation. I believe they will be ironing out details of how to do this. The FDA cannot say do x, y, and z, as they will want to clarify it is feasible for MSB and makes sense from a scientific viewpoint .If MSB had bad news and they were trying to spin I would expect it to be released on Friday Aus time. It appears the MSB scientific team will be meeting with FDA officials, to come up with a plan the FDA are happy with. And once this is signed off, approval will be granted with the agreed to conditions facilitating ongoing validation.

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Mja-!i tent to disagree FDA had weeks to review data and ask questions not at 11th hour. FDA is just delayed.. also it’s not that quick where we resubmit data and they look at it immediately and give Ok within few hours.. they have processes mate..

MSB Price at posting: $5.08 Sentiment: Buy Disclosure: Held
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0 Great analysis

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