2023 The Final Countdown, page-3161

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reginaldp

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01/08/23

09:40

Post #: 69093901
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Originally posted by col69: ↑

The potential approval on Thursday AUS time, represents about up to 200 patients per year, and around *$500,000 US per treatment with similar market penetration rates as JCR pharma in Japan with the sister product.

This is why I posted what I did yesterday here:

https://hotcopper.com.au/threads/2023-the-final-countdown.7156737/page-3139?post_id=69085271

The company has informed the market on multiple occasions that we have circa $30 million in Remestemcel-L stock ready to go - why did we spend another $7.2 million on manufacturing activities (I understand all of this won't equate to new stock) in the June quarter without a signed off FDA approval when surely we have at least 6 months supply ready to go and ramping up production on Friday would surely replenish stocks in time ?

Isn't this expenditure a risk that we would be left yet again holding all of this new stock in the case of a CRL ? Seems risky without the FDA approval in hand although I have no idea of what the ongoing collegial discussions at the FDA have revealed ? I guess if you received a sign off on labelling then you could undertake certain activities with a high level of confidence but even that still isn't a 100% guarantee ?

View attachment 5480321

@@Ziebes1 I am asking questions as you can see above and in my other posts ? I am trying to look at both sides of the equation but I do think Mesoblast have a much better chance at approval this time around .... even if that is reduced down to an AA, it will still be a big win for the company unlike what many are saying

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Col69 - Manufacturing activities expenditure excess spend would have been inspection readiness and the actual inspection imo

Only added $1m of stock

Reg

MSB Price at posting: $1.15 Sentiment: Buy Disclosure: Held
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2023 The Final Countdown, page-3161

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2023 The Final Countdown, page-3161

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