What's desperate is the FDA continues to allow emergency use because Remsestemcel-L WORKS. Otherwise they would disallow plus they don't want children's deaths on their watch.
The assays are just a side issue and reflects the caprice and proclivities of the FDA. Could have been easily done in post approval reporting.
But while the FDA continue to hold up therapies that work, others might get to enter the game and also competition from the old technology along with vested interests, is secure.
It's been a long time and someone still wants to kneecap MSB so we don't get to charge actual $ for the supply of this life saving therapy.
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