Off Label use.....
Given the ongoing appeal by the FDA in this case >
United States v. California Stem Cell Treatment Center - Food and Drug Law Institute (FDLI)
Maybe a % of the many stem cell clinics will come cap in hand to MSB for 'legal' cells to use for their work.
From memory the FDA won for most of their claims but the interim decision allows 2 of the products to be used which the FDA has appealed.
The FDA may end up being responsible for a great deal of revenue coming MSB's way.
Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-398
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