In "hindsight" it looks like (presumably) Novartis paid DC lawyers to petition the FDA on the 20th of July to not approve Reme for GVHD. These reasons look suspiciously like the issues raised in the briefing pack in Aug and then the FDA were suprised that ODAC approved it so then they went against that ruling to keep (presumably) Novartis happy??
See full letter here.https://beta.regulations.gov/document/FDA-2020-P-1689-0001
We lost a ton of $$ and now they partner up with us 2 months later after the crash. Coincidence?
Still this now bodes well for getting GVHD over the line on appeal? They will have all come to an agreement behind closed doors so Novartis gets a stake and kids can now get treated? I wonder how many lives were lost with the delay?
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