Whytee- we agree with you. An RCT would provide the most
robust evidence to support efficacy of Ryoncil.
That's what you have left to argue. All matters relating to Oriris,
ODAC, efficacy, potency , manufacturing etc- all gone bye byes.
Resubmission accepted- No day 74 issues - no 483 letter .
Will the FDA approve Ryoncil based on a single arm trial or will they insist upon an RCT?
No-one knows.
It puts pressure on the FDA - they negligently approved Rux based on a single arm trial and it doesn't work. Now the argument is they can't approve based on a single arm trial for a product that works.
You say only an RCT will prove it works- I agree - that would be the most conclusive evidence. That 4 year survival data must be causing some angst within the FDA
So we wait- but please , for you sanity and mine, that's all you have left to argue.
Keep punchin buddy
Reg
Ann: MSB Reports Q3 Financial Results and Operational Highlights, page-328
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