So the Adult aGVHD trial and then 100 day readouts will take around 12 to 14 months from the Type A meeting?
Realistically how long will it take after the adult aGVHD trail ends and readouts done will MSB take to resubmit?
Then how much time does the FDA need to reassess the new trial data and then provide an approval answer.
Fine for the trial 12 much I am trying to determine the likely time frame here from now until FDA approval as that is the most likely path and one that has to be taken anyway for adults.
Are we talking 2 years from Type A meeting for the actual approval to come down? Or longer ….as everything takes longer than we expect for MSB and the FDA.
Keen to ensure everyone is on a realistic time frame page here.
I know we may jag a better scenario on AA or early data reads but realistically they have not panned out in the past and are best case scenarios - we need to be realistic on the time to any aGVHD approval.
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So the Adult aGVHD trial and then 100 day readouts will take...
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