I'm going to bang on about the 3D manufacturing again. Try and keep up.
1. MSB has argued that the Osiris trials done 10 odd years ago should not be taken into the FDA's consideration because of the low quality and low potency aspects compared to all the 2D manufactured cell trials. Maybe MSB is correct but this related to aGVHD and we know that it didn't receive FDA approval or any additional acceleration consideration since. 2. 3D has had a CR (US$90M). 3D has $50M payment attached to it from the Novartis deal plus royalties etc. which should really provide a full return on the CR pretty quickly.
Why would the EU trial be done with 2D cells?
If the EU trial was to be successful the volume of demand couldn't be satisfied by 2D as 3D scale would be required. And from what has been stated by SI and the gang that quality/uniformity/potency of the cells with 3D will be highest.
In my mind there is not a reason to trial 2D cells for anything other than aGVHD (or other small volume applications which does not include ARDS, CLBP & CHF) due to the scale required. And there has been no progress on 3D manufacturing. So, talking up anything outside of aGVHD doesn't make sense until 3D is satisfied.
MSB Price at posting:
$1.84 Sentiment: Hold Disclosure: Held
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