MSB 3.33% $1.40 mesoblast limited

Ann: Mesoblast Completes Resubmission of BLA to FDA for SR-aGVHD, page-179

  1. 4,209 Posts.
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    Well... yes, I didn't want evidence that was not directly attributable to your concern that FDA may reject Ryoncil on the basis of Interferon Gamma levels not changing.

    The evidence you provided, did not in my opinion demonstrate at all that MSB has ever claimed their product modulates Inf Gamma. In fact you showed me the CMC graph which even stated specifically the product does not alter INF Gamma levels, and as I said they do not appear to have changed even by a factor of 2, possibly 1.5. And still being wildly above "normal" levels seen circulating, so I would say no affect is an accurate description.


    The only evidence from MSB is that Ryoncil does the complete opposite, in that it has no effect on Inf Gamma levels. That is their actial claim. Now, I fail to see a logical way the FDA will weave that into any argument against the product. Just like they would not be able to deny a TNFAlpha treatment, that has no affect on inf gamma.
 
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