Hi Techinvestor –
“… the literature control was always a potential weak point as I've expressed before, and one FDA will invariably challenge. MSB took a calculated risk here, we'll see how it pans out.”
My reading of the FDA briefing note p7 is that the FDA told MSB that a single arm trial was potentially approvable but that it had to be designed and reviewed before it was conducted.
MSB appear not have got the tick of approval from the FDA before the trial was conducted.
The FDA is now saying that the historical control estimate is unacceptable, and the MAGIC study doesn’t fix the problem.
If this is the case it is pretty scandalous. The trial had failed before it had started because of the inappropriate (deemed by the FDA) control. Everybody wasted their time.
Id love to hear why this way of looking at things is wrong. Any thoughts?
Regards southoz
Hi Techinvestor – “… the literature control was always a...
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