Ann: Third Quarter Results Presentation, page-8

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    I think the major problem with the BLA process is that it is new for both the FDA and MSB. The excitement with MSCs is they are new, but new is never fast when it involves the FDA.

    To answer your question no MSB does not need to wait for feedback on each section before submitting the next module, but I suspect the it might be a little while before the next module goes in purely because the FDA won't be ready to look at it until they have had a good look at the first module. I hope I am wrong here, but at least we can see the finish line in sight now.
 
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