Where is Novartis?, page-120

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ddwn

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21/05/21

16:23

Post #: 53337441
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Originally posted by stockrock: ↑

Just have a hunch that Novartis are probably going to take up full rights to remestemcel-l i.e. including Ryoncil for SR-aGVHD.

Based on the lack of update, I can only assume that the FDA has kept it's position in that it wants an RCT run before it can give any approval for Ryoncil. If this is the case, it then becomes a bridge too far IMO to go it alone for such a small market... this is in light of much larger heart, backpain and ARDS indications that may also come online the same time as SR-aGVHD.

So if Novartis are held up a bit, it may just be that Mesoblast are trying to extend the collaboration beyond ARDS. Of course this is just a hunch, so take it with a pinch of salt .. or maybe a teaspoon.

And remember... MSB's MPCs and MSCs work across multiple indications... this has been shown in large scale and well controlled phase 3 randomised controlled trials... what MSB hasn't quite been able to nail is the trial design, and in all fairness when you are a small biotech trying to pioneer stem cell research.. and running the largest RCT's ever run globally.. it was always going to be a challenge to be able to get it completely right the first time around... Novartis now have a chance to run a second round of RCT's with much more confidence... remestemcel-l with Dex for ARDS for under 65yrs... what big pharma looking at Heart and lower back pain (in the US) are in the same boat.

Second half of 2021 is going to be packed with FDA and partnership updates... good or bad, that's the risk we take.. but the announcements are coming.

Goodluck all

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That's an interesting take on it @stockrock

Personally, I hope & think the EUA for Ryoncil is still in play.

It's frustrates me at how slow things are moving, on multiple fronts, but that's the nature of the beast.
I have to and can accept these elongated timeframes, as long as I can see some indications that we'll get favourable outcomes

I live in hope

MSB Price at posting: $1.88 Sentiment: Buy Disclosure: Held
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Where is Novartis?, page-120

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Where is Novartis?, page-120

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