It’s possible that MSB tried to hit a home run with their application to have Ryoncil approved for up to 18 years. The safest bet in hindsight may have been to settle with 3rd base in seeking approval for children under 12 as this is where there is no approved treatment.
Nobody can predict the outcome of a Type A meeting with the FDA but I would like to think that an ethical, practical and administratively sound compromise will be reached.
MSB have stated that 309 children (under 18) have been treated with Ryoncil across the 3 trials. I would be interested to know (I can’t find the data), how many children under 12 years of age were treated in these trials and how many responded favourably. I’m assuming this may be relevant for the meeting and FDA’s determination?
It’s possible that MSB tried to hit a home run with their...
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