They are in the dark and the only vote is “is the product worth it” basically.
considering it’s totally safe. Batch consistency is predominantly there and the p3 was UNAMBIGUOUS and there is no alternative.
it would be stunning if they recommended a no vote based on how this is going. If that occurred it would only demonstrate in my mind that ODAC have clueless people on the panel when it comes to stem cells.
they are asking the same question different ways and Silviu is using the same slides again and he’s having to repeat himself etc.
many panel members are silent which I take to be a good thing but it might not be either.
If they don’t vote yes then it would really be a surprise and only demonstrate they have a huge lack of brain power on that panel to appropriately understand stem cells.
constant whinging about In Vivo when every subject matter expert has said that it is basically impossible to do that test due to the nature of the product so they have to use other tests
Ryoncil: ODAC/FDA Meeting Discussion, page-846
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