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91.5¢ mesoblast limited

Ann: Mesoblast Q3 Financial Results Webcast, page-106

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Cato

7,294 Posts.

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03/06/21

09:42

Post #: 53611949
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Originally posted by imback: ↑

John Hester, right on ball. Exact question I wanted to ask: CMC issue and/or new RCT needed? Looks like they may not need the RCT, just CQA data which MSB have created additional data for and will present to FDA in a couple of months. 'General agreement' on approach with FDA, according to SI. Promising.

I thought they had solid data at ODAC on the correlation of their CQA with outcomes and potency. It was different to the what FDA wanted and it wasn't as clean cut as one would have liked, so they weren't prepared to give them any leeway. FDA asked the ODAC panel to come up with alternative CQA's which is a bit like asking your lawyer how to conduct a skin graft operation. It's now being worked through with a specialist department at FDA. It's a process but good to not hear any more complaints on efficacy data from FDA.

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Hi Imabck

I was interested to listen how they "hold" the 9x1.. Yes, absolutely YES they are holding that as a especial card in their hands and of course FDA board cant just pretend and make ridiculous 9 of their top doctors.They said YES and board said No.
Now they need face an internal [pressure of people suggesting.. welll..maybe u should fire all !

GVHD will be soon than many think aproved.

CATO

MSB Price at posting: $1.92 Sentiment: Buy Disclosure: Held
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