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$1.15 mesoblast limited

Might explain some of the US etc Buying...

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HOLIDAY1

2,161 Posts.

73

02/04/24

19:36

Post #: 73155343
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Originally posted by reginaldp: ↑

December 31 2023- Company advises they have generated the potency data requested by the FDA. ie we have answered the CRL
February 29 2024- Company advised new potency assay data was with the FDA and a follow up meeting scheduled

March 26th 2024- The FDA responds to the potency data provided , which the company prepared specifically in answer to the CRL.

So the potency data was with the FDA for a month. They checked it to see whether it answered the problems specifically raised in the CRL.

If it didn't answer the CRL then they would have received a negative reply.

Instead the company released a statement saying the FDA NOTIFIES MESOBLAST
THAT AVAILABLE CLINICAL DATA FROM PHASE 3 TRIAL APPEAR SUFFICIENT TO
SUPPORT BLA SUBMISSION FOR REMESTEMCEL-L IN CHILDREN WITH STEROIDREFRACTORY ACUTE GRAFT VERSUS HOST DISEASE (SR-aGVHD)

They don't say the potency data is sufficient- but they may as well have. We are not being told to proceed because the data is crap, rather- spectacularly- it answers the CRL.

This stock is now about dollars not cents.

Safety/Efficacy/Manufacturing and now presumably potency is done and dusted.

The company has never been in a better position

ever

Reg

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Might explain some of the US etc Buying...

MSB Price at posting: 95.0¢ Sentiment: Buy Disclosure: Held
6 Upvote

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