FDA criticized by congress

What a total debacle……it is the identical ‘flip side outcome’ to our Ryoncil situation. Such a pity that the Congressional Committee didn’t highlight our case as a comparison to Aduheim….,.ie a therapy that was actually effective & efficacious..,,,9-1 ODAC approved…..no existing SOC for young children …boxes galore all ticked……yet ‘talk to the hand’ from the FDA. Hopefully common sense & justice prevails in 2023.

Cannot say this is good news if you are trying to get something approved without proper controlled trials.

I’d say any bio company trying approval with sliced and diced data will struggle. Maybe msb lost the chance two years ago. Now, there might be a lot more scrutiny. And the big wheels rolled out by msb given a lot less weight.