As already mentioned here, that FDA stance on trial data, MOA's and especially manufacting will create a massive moat and first mover advantage for MSB.The FDA presented a lot of what the have been playing with in their labs on stem cells and was a little disconcerting some of the conclusions they were making. I think any stem cell based manufacturer better have very strong and validated CQA's in the future because FDA basically beleive stem cells have thousands of properties which are potentially significantly different from donor to donor as well as after each cell replication. So some of those other techniques/IP which rely on hundreds of replications better watch out!
I still firmly believe SI's confidence and skill completely mitigated the risk of a less favorable vote.
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