Mesoblast CC Transcript 31/8, page-38

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reginaldp

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01/09/23

08:24

Post #: 69678757
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Originally posted by whytee: ↑

IMO SI is still looking for a way to try and convince the FDA that they could grant approval based on some more "generated data" before doing another trial in adults. The FDA still want to see all of the claims that SI makes about potency, mechanism of action, biomarkers and outcomes proven in a real life study. SI wants to try and add another small fragment to the puzzle and distract the FDA from looking at the whole picture and seeing the other holes.
Sleight of hand works for investors, why not the FDA? Because the FDA, like Novartis and TEVA has their own experts on clinical trials and biostatistics who know what they want and how to find it. They're not likely to be distracted from the main topic by a sideshow.

"We believe that we can link the product that was made in the Phase 3 trial to the current commercially risk product through additional work using potency data."

"The Type A meeting with the FDA is scheduled to be held in mid-September, and we will be laying out these exact strategies. We proposed providing FDA with additional potency assay data to provide the link between Phase 3 product and the current commercial inventory"

I don't think the FDA will accept this, it's more grasping at straws. They've said very clearly they want at least one well controlled trial before granting approval, and either SI just doen't listen or he's desperately trying to wedge a foot in the door because of concerns about money and investor faith in the company and doubts about the results of doing a proper clinical trial, most likely all three. I see the CFO is still claiming that another $40m is still available subject to secret milestones. Realistically, those milestones can't possibly be met in the next few weeks so that renegotiated agreement is about to reach a conclusion.

So I think any excitement or hope now is probably misplaced. That type A meeting is likely to result in the FDA making it plain to SI that they really do want/recommend a well controlled clinical trial in adults as the pathway to approval and this is what it needs to show. That's likely to lead to some disappointment among investors hoping for some shortcut to get the company out of the hole that managent have dug (and they still can't quit digging it seems...)

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No Whytee.

Remember the FDA wanted further proof of efficacy at Adcom

Now they want potency assurance for product on the shelf.

No trickery involved- no sleight of hand- no ruse

Perhaps have another listen, or read the transcript

or buy some stock

Double the survival benefit n71 salvage therapy adult patients

Reg

MSB Price at posting: 51.0¢ Sentiment: Buy Disclosure: Held
11 Upvote

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Mesoblast CC Transcript 31/8, page-38

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Mesoblast CC Transcript 31/8, page-38

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